TRAZODONE HYDROCHLORIDE - trazodone hydrochloride tablet 
Aurolife Pharma, LLC

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS .

TRAZODONE HYDROCHLORIDE tablets, for oral use
Initial U.S. Approval: 1981

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
See full prescribing information for complete boxed warning.




• Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients (5.1)
• Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors (5.1)
• Trazodone hydrochloride tablets are not approved for use in pediatric patients (8.4)



INDICATIONS AND USAGE

Trazodone hydrochloride tablets are selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) (1). (1)

DOSAGE AND ADMINISTRATION

• Starting dose: 150 mg in divided doses daily. May be increased by 50 mg per day every three to four days.  Maximum dose: 400 mg per day in divided doses (2).
• Trazodone Hydrochloride Tablets should be taken shortly after a meal or light snack (2).
• Tablets should be swallowed whole or broken in half along the score line, and should not be chewed or crushed (2).
• When discontinued, gradual dose reduction is recommended (2).



DOSAGE FORMS AND STRENGTHS

  • Scored tablets:  50 mg, 100 mg,  150 mg   and 300 mg   (3).

CONTRAINDICATIONS

  •   Concomitant   use of monoamine oxidase inhibitors (MAOIs), or   use within  14 days of   stopping   MAOIs (4).

WARNINGS AND PRECAUTIONS



  • Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue Trazodone hydrochloride tablets and initiate supportive treatment (5.2).
  • Cardiac Arrhythmias: Increases the QT interval. Avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval (5.3)
  • Orthostatic Hypotension and Syncope: Warn patients of risk and symptoms of hypotension (5.4).
  • Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk (5.5).
  • Priapism: Cases of painful and prolonged penile erections and priapism have been reported. Immediate medical attention should be sought if signs and symptoms of prolonged penile erections or priapism are observed (5.6).
  • Activation of Mania or Hypomania: Screen for bipolar disorder and monitor for mania or hypomania (5.7).
  • Potential for Cognitive and Motor Impairment: Has potential to impair judgment, thinking, and motor skills. Advise patients to use caution when operating machinery (5.9).
  • Angle-Closure Glaucoma: Avoid use of antidepressants, including Trazodone hydrochloride tablets, in patients with untreated anatomically narrow angles. (5.10).

ADVERSE REACTIONS



Most common adverse reactions (incidence ≥ 5% and twice that of placebo) are: edema, blurred vision, syncope, drowsiness, fatigue, diarrhea, nasal congestion, weight loss (6).
 
To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma Usa, Inc. at  1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.



DRUG INTERACTIONS


  • CNS Depressants: Trazodone hydrochloride tablets may enhance effects of alcohol, barbiturates, or other CNS depressants (7).
  • CYP3A4 Inhibitors: Consider Trazodoen hydrochloride tablets dose reduction based on tolerability (2.5, 7).
  • CYP3A4 Inducers: Increase in Trazodone hydrochloride tablets dosage may be necessary (2.5, 7).
  • Digoxin or Phenytoin: Monitor for increased digoxin or phenytoin serum levels (7).
  • Warfarin: Monitor for increased or decreased prothrombin time (7).


USE IN SPECIFIC POPULATIONS


  • Pregnancy: Based on animal data, may cause fetal harm (8.1).
  • Nursing Mothers: Use with caution (8.3).


See 17 for PATIENT COUNSELING INFORMATION.

Revised: 1/2020

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING:SUICIDAL THOUGHTS AND BEHAVIORS

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Dose Selection

2.2 Important Administration Instructions

2.3 Screen for Bipolar Disorder Prior to Starting Trazodone hydrochloride tablets

2.4 Switching to or from Monoamine Oxidase Inhibitor Antidepressant

2.5 Dosage Recommendations for Concomitant Use with Strong CYP3A4 Inhibitors or Inducers

2.6 Discontinuation of Treatment with Trazodone hydrochloride tablets

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients

5.2 Serotonin Syndrome

5.3 Cardiac Arrhythmias

5.4 Orthostatic Hypotension and Syncope

5.5 Increased Risk of Bleeding

5.6 Priapism

5.7 Activation of Mania or Hypomania

5.8 Discontinuation Syndrome

5.9 Potential for Cognitive and Motor Impairment

5.10 Angle-Closure Glaucoma

5.11 Hyponatremia

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience

6.2 Post marketing Experience

7 DRUG INTERACTIONS

7.1 Drugs Having Clinically Important Interactions With Trazodone hydrochloride

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

9.2 Abuse

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis,Mutagenesis,Impairment Of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.

FULL PRESCRIBING INFORMATION

WARNING:SUICIDAL THOUGHTS AND BEHAVIORS

WARNING: SUICIDAL THOUGHTS and BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies.  Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)]. Trazodone Hydrochloride Tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4)].

1 INDICATIONS AND USAGE

Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.

2 DOSAGE AND ADMINISTRATION

2.1 Dose Selection


An initial dose of 150 mg/day in divided doses is suggested. The dosage should be initiated at a low-dose and increased gradually, noting the clinical response and any evidence of intolerance. Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage.
The dose may be increased by 50 mg/day every 3 to 4 days. The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses. Inpatients (i.e., more severely depressed patients) may be given up to but not in excess of 600 mg/day in divided doses.
Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response.

2.2 Important Administration Instructions

Trazodone hydrochloride tablets can be swallowed whole or administered as a half tablet by breaking the tablet along the score line. Trazodone hydrochloride tablets should be taken shortly after a meal or light snack.

2.3 Screen for Bipolar Disorder Prior to Starting Trazodone hydrochloride tablets

Prior to initiating treatment with Trazodone hydrochloride tablets or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.7)].

2.4 Switching to or from Monoamine Oxidase Inhibitor Antidepressant

At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of Trazodone hydrochloride tablets. In addition, at least 14 days must elapse after stopping Trazodone hydrochloride tablets before starting an MAOI antidepressant [see Contraindications (4), Warnings and Precautions (5.2)].

2.5 Dosage Recommendations for Concomitant Use with Strong CYP3A4 Inhibitors or Inducers


Coadministration with Strong CYP3A4 Inhibitors
Consider reducing Trazodone hydrochloride tablets dose based on tolerability when Trazodone  coadministered with a strong CYP3A4 inhibitor [see Drug Interactions (7.1)].
Coadministration with Strong CYP3A4 Inducers
Consider increasing Trazodone hydrochloride tablets dose based on therapeutic response when Trazodone coadministered with a strong CYP3A4 inducer [see Drug Interactions (7.1)].

2.6 Discontinuation of Treatment with Trazodone hydrochloride tablets

Adverse reactions may occur upon discontinuation of Trazodone hydrochloride tablets [SeeWarnings and Precautions (5.8)]. Gradually reduce the dosage rather than stopping Trazodone hydrochloride tablets abruptly whenever possible.

3 DOSAGE FORMS AND STRENGTHS

Trazodone hydrochloride tablets,USP are available in the following strengths:

4 CONTRAINDICATIONS

Trazodone hydrochloride tablets are contraindicated in:

5 WARNINGS AND PRECAUTIONS

5.1 Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients


In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 4,400 pediatric patients, the incidence of suicidal thoughts and behaviors in pediatric and young adult patients was greater in antidepressant-treated patients than in placebo-treated patients. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 1.
No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide.
Table 1: Risk Differences of the Number of Cases of Suicidal Thoughts or Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients

Age   Range   (years) Drug-Placebo   Difference  in   Number of Patients  of   Suicidal   Thoughts  or Behaviors  per 1000   Patients   Treated
  Increases Compared to   Placebo  
      <18  14   additional   patients
       18-24  5   additional   patients
  Decreases   Compared to Placebo  
       25-64  1   fewer patient
      ≥65    6   fewer patients


It is unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adult patients extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression.
Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing Trazodone hydrochloride tablets, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

5.2 Serotonin Syndrome


Serotonin-norepinephrine reuptake inhibitors (SNRIs) and SSRIs, including Trazodone, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs [see Contraindications(4), Drug Interactions (7.1)]. Serotonin syndrome can also occur when these drugs are used alone.

Serotonin syndrome signs and symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

The concomitant use of Trazodone with MAOIs is contraindicated. In addition, do not initiate Trazodone hydrochloride tablets in a patient being treated with MAOIs such as linezolid or intravenous methylene blue. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection). If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking Trazodone, discontinue Trazodone  before initiating treatment with the MAOI [seeContraindications (4), Drug Interactions (7.1)].

Monitor all patients taking Trazodone for the emergence of serotonin syndrome. Discontinue treatment with Trazodone and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of Trazodone with other serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome and monitor for symptoms.

5.3 Cardiac Arrhythmias


Clinical studies indicate that trazodone hydrochloride may be arrhythmogenic in patients with preexisting cardiac disease. Arrhythmias identified include isolated PVCs, ventricular couplets, tachycardia with syncope, and torsade de pointes. Postmarketing events, including torsade de pointes have been reported at doses of 100 mg or less with the immediate-release form of Trazodone. Trazodone should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval. Trazodone are not recommended for use during the initial recovery phase of myocardial infarction. Caution should be used when administering Trazodone to patients with cardiac disease and such patients should be closely monitored, since antidepressant drugs (including Trazodone hydrochloride tablets) may cause cardiac arrhythmias [see Adverse Reactions (6.2)].

Trazodone prolongs the QT/QTc interval. The use of Trazodone should be avoided in patients with known QT prolongation or in combination with other drugs that are inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, voriconazole), or known to prolong QT interval including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), certain antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and certain antibiotics (e.g., gatifloxacin). Concomitant administration of drugs may increase the risk of cardiac arrhythmia [see Drug Interactions (7.1)].

5.4 Orthostatic Hypotension and Syncope

Hypotension, including orthostatic hypotension and syncope has been reported in patients receiving trazodone hydrochloride. Concomitant use with an antihypertensive may require a reduction in the dose of the antihypertensive drug.

5.5 Increased Risk of Bleeding


Drugs that interfere with serotonin reuptake inhibition, including Trazodone, increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDS), other antiplatelet drugs, warfarin, and other anticoagulants may add to this risk.

Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding events related to drugs that interfere with serotonin reuptake have ranged from ecchymosis, hematoma, epistaxis, and petechiae to life-threatening hemorrhages.

Inform patients about the risk of bleeding associated with the concomitant use of Trazodone and antiplatelet agents or anticoagulants. For patients taking warfarin, carefully monitor coagulation indices when initiating, titrating, or discontinuing Trazodone hydrochloride tablets.

5.6 Priapism


Cases of priapism (painful erections greater than 6 hours in duration) have been reported in men receiving Trazodone. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Men who have an erection lasting greater than 4 hours, whether painful or not, should immediately discontinue the drug and seek emergency medical attention [see Adverse Reactions (6.2), Overdosage (10)].

Trazodone should be used with caution in men who have conditions that might predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia), or in men with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie’s disease).

5.7 Activation of Mania or Hypomania

In patients with bipolar disorder, treating a depressive episode with Trazodone or another antidepressant may precipitate a mixed/manic episode. Activation of mania/hypomania has been reported in a small proportion of patients with major affective disorder who were treated with antidepressants. Prior to initiating treatment with Trazodone hydrochloride tablets, screen patients for any personal or family history of bipolar disorder, mania, or hypomania [see Dosage and Administration (2.3)].

5.8 Discontinuation Syndrome

Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include: nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesia, such as electric shock sensations), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible [See Dosage and Administration (2.6)].

5.9 Potential for Cognitive and Motor Impairment

Trazodone hydrochloride tablets may cause somnolence or sedation and may impair the mental and/or physical ability required for the performance of potentially hazardous tasks. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that the drug treatment does not affect them adversely.

5.10 Angle-Closure Glaucoma

The pupillary dilation that occurs following use of many antidepressant drugs including Trazodone hydrochloride tablets may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Avoid use of antidepressants, including Trazodone hydrochloride tablets, in patients with untreated anatomically narrow angles.

5.11 Hyponatremia


Hyponatremia may occur as a result of treatment with SNRIs and SSRIs, including Trazodone. Cases with serum sodium lower than 110 mmol/L have been reported. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which can lead to falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH).

In patients with symptomatic hyponatremia, discontinue Trazodone hydrochloride tablets and institute appropriate medical intervention. Elderly patients, patients taking diuretics, and those who are volume-depleted may be at greater risk of developing hyponatremia with SSRIs and SNRIs [see Use in Specific Populations (8.5)].

6 ADVERSE REACTIONS


The following serious adverse reactions are described elsewhere in the labeling:


6.1 Clinical Studies Experience


Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Table 2: Common Adverse Reactions Occurring in ≥ 2% of Trazodone-treated Patients and Greater than the Rate of Placebo-Treated Patients as Observed in Controled Clinical Studies

 
Inpatients
Outpatients
 
Trazodone Hydrochloride Tablets
N=142
Placebo N=95
Trazodone Hydrochloride Tablets
=157
Placebo N=158
Allergic 
Skin Condition/Edema
3%
1%
7%
1%
Autonomic 
Blurred Vision
6%
4%
15%
4%
Constipation
7%
4%
8%
6%
Dry Mouth
15%
8%
34%
20%
Cardiovascular 
Hypertension
20%
1%
1%
*
Hypotension
7%
1%
4%
0
Syncope
3%
2%
5%
1%
CNS 
Confusion
5%
0
6%
8%
Decreased Concentration
3%
2%
1%
0
Disorientation
2%
0
*
0
Fatigue
11%
4%
6%
3%
Headache
10%
5%
20%
16%
Nervousness
15%
11%
6%
8%
Gastrointestinal 
Abdominal/Gastric Disorder
4%
4%
6%
4%
Diarrhea
0
1%
5%
1%
Nausea/Vomiting
10%
1%
13%
10%
Musculoskeletal
 
 
 
 
Aches/Pains
6%
3%
5%
3%
Neurological 
 
 
 
 
Incoordination
5%
0
2%
*
Tremors
3%
1%
5%
4%
Other 
Eyes Red/Tired/Itching
3%
0
0
0
Head Full-Heavy
3%
0
0
0
Malaise
3%
0
0
0
Nasal/Sinus Congestion
3%
0
6%
3%
Weight Gain
1%
0
5%
2%
Weight Loss
*
3%
6%
3%



Other adverse reactions occurring at an incidence of <2% with the use of trazodone hydrochloride in the controlled clinical studies: akathisia, allergic reaction, anemia, chest pain, delayed urine flow, early menses, flatulence, hallucinations/delusions, hematuria, hypersalivation, hypomania, impaired memory, impaired speech, impotence, increased appetite, increased libido, increased urinary frequency, missed periods, muscle twitches, numbness, paresthesia, retrograde ejaculation, shortness of breath, and tachycardia/palpitations. Occasional sinus bradycardia has occurred in long-term studies.

6.2 Post marketing Experience


The following adverse reactions have been identified during post-approval use of Trazodone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure:

Blood and lymphatic system disorders:
hemolytic anemia, leukocytosis

Cardiac disorders: cardiospasm, congestive heart failure, conduction block, orthostatic hypotension and syncope, palpitations, bradycardia, atrial fibrillation, myocardial infarction, cardiac arrest, arrhythmia, ventricular ectopic activity, including ventricular tachycardia and QT prolongation.  Prolonged QT interval, torsade de pointes, and ventricular tachycardia have been reported at doses of 100 mg per day or less [see Warnings and Precautions (5.3)].
Endocrine disorders: inappropriate ADH syndrome
Eye disorders: diplopia
Gastrointestinal disorders: increased salivation, nausea/vomiting
General disorders and administration site conditions: chills, edema, unexplained death, weakness 
Hepatobiliary disorders: cholestasis, jaundice, hyperbilirubinemia, liver enzyme alterations 
Investigations: increased amylase
Metabolism and nutrition disorders: methemoglobinemia
Nervous system disorders: aphasia, ataxia, cerebrovascular accident, extrapyramidal symptoms, grand mal seizures, paresthesia, tardive dyskinesia, vertigo
Psychiatric disorders: abnormal dreams, agitation, anxiety, hallucinations, insomnia, paranoid reaction, psychosis, stupor
Renal and urinary disorders: urinary incontinence, urinary retention
Reproductive system and breast disorders: breast enlargement or engorgement, clitorism, lactation, priapism [see Warnings and Precautions (5.6)]
Respiratory, thoracic and mediastinal disorders: apnea
Skin and subcutaneous tissue disorders: alopecia, hirsutism, leukonychia, pruritus, psoriasis, rash, urticaria
Vascular disorders: vasodilation

7 DRUG INTERACTIONS

7.1 Drugs Having Clinically Important Interactions With Trazodone hydrochloride

Table 3: Clinically Important Drug Interactions with Trazodone hydrochloride tablets

Monoamine   Oxidase   Inhibitors   (MAOIs) 
Clinical  Impact: 
The   concomitant use  of   MAOIs   and   serotonergic   drugs including   Trazodone hydrochloride tablets   increases the  risk  of   serotonin   syndrome. 
Intervention: 
Trazodone hydrochloride tablets  is   contraindicated   in   patients   taking   MAOIs, including   MAOIs  such   as   linezolid  or  intravenous methylene   blue [see    Contraindications   (4) , Dosage   and   Administration   (2.3, 2.4),  and  Warnings and Precautions   (5.2) ]. 
Examples: 
isocarboxazid, moclobemide,   phenelzine,   selegiline, tranylcypromine 
Other Serotonergic   Drugs 
Clinical  Impact: 
The   concomitant use  of   serotonergic   drugs including   Trazodone hydrochloride tablets  and  other   serotonergic   drugs   increases   the   risk of   serotonin   syndrome. 
Intervention: 
Monitor patients for   signs   and   symptoms of   serotonin   syndrome, particularly during   Trazodone hydrochloride tablets   initiation.   If serotonin   syndrome   occurs, consider   discontinuation  of DESYREL  and/or   concomitant serotonergic   drugs   [see    Warnings and   Precautions   (5.2) ]. 
Examples: 
triptans,   antidepressants   (tricyclic   and   serotonin   uptake   inhibitors),   fentanyl,   lithium, tramadol,   tryptophan, buspirone, and   St.   John's  Wort 
Antiplatelet Agents  and   Anticoagulants 
Clinical  Impact: 
Serotonin   release  by platelets plays   an   important role  in   hemostasis.   The   concurrent use   of an   antiplatelet   agent or   anticoagulant with Trazodone hydrochloride tablets may potentiate   the   risk of   bleeding. 
Intervention: 
Inform patients  of  the   increased   risk  of   bleeding   with   the   concomitant use  of   Trazodone hydrochloride tablets and   antiplatelet   agents and   anticoagulants.  For   patients   taking   warfarin, carefully monitor  the   international   normalized   ratio   (INR) when   initiating  or   discontinuing   Trazodone hydrochloride tablets [see    Warnings  and   Precautions   (5.5) ]. 
Examples: 
warfarin, rivaroxaban, dabigatran, clopidogrel 
Strong CYP3A4   Inhibitors 
Clinical  Impact: 
The   concomitant use  of   Trazodone hydrochloride tablets  and   strong   CYP3A4   inhibitors increased  the   exposure   of   trazodone   compared   to   the   use  of Trazodone hydrochloride tablets   alone. 
Intervention: 
If Trazodone hydrochloride tablets is   used   with  a   potent CYP3A4   inhibitor, the   risk of adverse   reactions, including   cardiac arrhythmias, may be   increased  and  a   lower dose  of Trazodone hydrochloride tablets  should  be   considered  [see    Dosage   and   Administration  (2.5),    Warnings   and   Precautions   (5.3)] . 
Examples: 
itraconazole, ketoconazole,   clarithromycin, indinavir 
Strong CYP3A4   Inducers 
Clinical  Impact: 
The   concomitant use  of   Trazodone hydrochloride tablets  and   strong   CYP3A4   inducers decreased  the   exposure  of   trazodone   compared   to   the   use  of Trazodone hydrochloride tablets   alone. 
Intervention: 
Patients should  be  closely monitored  to  see  if there  is  a   need  for an   increased   dose  of Trazodone hydrochloride tablets   when   taking   CYP3A4   inducers   [see   Dosage   and   Administration   (2.5)]. 
Examples: 
rifampin,   carbamazepine, phenytoin, St.   John’s   wort
Digoxin and Phenytoin 
Clinical  Impact: 
Digoxin  and   phenytoin  are   narrow   therapeutic index  drugs. Concomitant  use  of Trazodone hydrochloride tablets can  increase   digoxin  or phenytoin   concentrations. 
Intervention: 
Measure   serum   digoxin  or phenytoin   concentrations before   initiating   concomitant use  of   Trazodone hydrochloride tablets. Continue   monitoring  and   reduce   digoxin  or   phenytoin   dose   as   necessary. 
Examples: 
digoxin, phenytoin 
Central Nervous   System   (CNS) Depressants 
Clinical  Impact: 
Desyrel   may enhance  the   response   CNS depressants. 
Intervention: 
Patients should  be   counseled   that Trazodone hydrochloride tablets may   enhance   the   response   to   alcohol,   barbiturates,  and  other CNS   depressants. 
Examples: 
alcohol,   barbiturates 
QT Interval Prolongation 
Clinical  Impact: 
Concomitant use  of drugs that   prolong   the   QT   interval  may add  to   the   QT   effects of Trazodone hydrochloride tablets  and   increase  the   risk   of cardiac   arrhythmia. 
Intervention: 
Avoid  the  use  of Trazodone hydrochloride tablets in   combination   with   other drugs known  to   prolong   QTc   [see    Warnings and   Precautions   (5.3) ]
Examples: 
Class  1A antiarrhythmics: quinidine, procainamide, disopyramide;  Class  3   antiarrhythmics: amiodarone, sotalol;  Antipsychotics: ziprasidone,   chlorpromazine, thioridazine;   Antibiotics:   gatifloxacin 

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

 


Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405- 6185 or visiting online at https://womensmentalhealth.org/clinical-and-research programs/pregnancy registry/antidepressants/


Risk Summary
Published prospective cohort studies, case series, and case reports over several decades with Trazodone Hydrochloride Tablets use in pregnant women have not identified any drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in the rat when given at dose levels approximately 7.3 to 11 times the maximum recommended human dose (MRHD) of 400 mg/day in adults on a mg/m2  basis. There was also an increase in congenital anomalies in the rabbit at approximately 7.3 to 22 times the MRHD on a mg/m2 basis (see Data).


The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.


Clinical Considerations


Disease-associated maternal and/or embryofetal risk
A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression that women who continued antidepressants. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.


Data


Human Data
While available studies cannot definitively establish the absence of risk, published data from prospective cohort studies, case series, and case reports over several decades have not identified an association with trazodone use during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. All available studies have methodological limitations, including small sample size and inconsistent comparator groups.


Animal Data
No teratogenic effects were observed when trazodone was given to pregnant rats and rabbits during the period of organogenesis at oral doses up to 450 mg/kg/day. This dose is 11 and 22 times, in rats and rabbits, respectively, the maximum recommended human dose (MRHD) of 400 mg/day in adults on a mg/m2 basis. Increased fetal resorption and other adverse effects on the fetus in rats at 7.3 to 11 times the MRHD and increase in congenital anomalies in rabbits at 7.3 to 22 times the MRHD on a mg/m2 basis were observed.  No further details on these studies are available.



8.2 Lactation

Risk Summary

Data from published literature report the transfer of trazodone into human milk. There are no data on the effect of trazodone on milk production. Limited data from post marketing reports have not identified and association of adverse effects on the breastfed child.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Trazodone Hydrochloride Tablets and any potential adverse effects on the breastfed child from Trazodone Hydrochloride Tablets or from the underlying maternal condition.

8.4 Pediatric Use

 Safety and effectiveness in the pediatric population have not been established. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning, Warnings and Precautions (5.1)].

8.5 Geriatric Use

Reported clinical literature and experience with trazodone has not identified differences in responses between elderly and younger patients. However, as experience in the elderly with trazodone hydrochloride is limited, it should be used with caution in geriatric patients.

Serotonergic antidepressants have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions (5.11)].

8.6 Renal Impairment

Trazodone has not been studied in patients with renal impairment. Trazodone should be used with caution in this population.

8.7 Hepatic Impairment

Trazodone has not been studied in patients with hepatic impairment. Trazodone should be used with caution in this population.

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

Trazodone hydrochloride tablets are not a controlled substance.

9.2 Abuse

Although trazodone hydrochloride has not been systematically studied in preclinical or clinical studies for its potential for abuse, no indication of drug-seeking behavior was seen in the clinical studies with trazodone hydrochloride.

10 OVERDOSAGE


Death from overdose has occurred in patients ingesting Trazodone and other CNS depressant drugs concurrently (alcohol; alcohol and chloral hydrate and diazepam; amobarbital; chlordiazepoxide; or meprobamate).
The most severe reactions reported to have occurred with overdose of Trazodone alone have been priapism, respiratory arrest, seizures, and ECG changes, including QT prolongation. The reactions reported most frequently have been drowsiness and vomiting. Overdosage may cause an increase in incidence or severity of any of the reported adverse reactions.
There is no specific antidote for trazodone hydrochloride overdose. In managing overdosage, consider the possibility of multiple drug involvement. For current information on the management of poisoning or overdose, contact a poison control center (1-800-222-1222 or www.poison.org).

11 DESCRIPTION


Trazodone hydrochloride tablets for oral administration contain trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1piperazinyl]propyl]-1,2,4-triazolo [4,3-a]pyridin-3(2H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows:
structure



Molecular Formula: C19H22CIN5O • HCl
Molecular Weight: 408.33

Each tablet, for oral administration, contains 50 mg, 100 mg, 150 mg or 300 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (physically modified corn (maize) starch), sodium lauryl sulfate, and sodium starch glycolate.

Meets USP Dissolution Test 2. 


12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The mechanism of trazodone’s antidepressant action is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS. Trazodone is both a selective serotonin reuptake inhibitor (SSRI) and a 5HT2 receptor antagonist and the net result of this action on serotonergic transmission and its role in trazodone’s antidepressant effect is unknown.

12.2 Pharmacodynamics

Preclinical studies have shown that trazodone selectively inhibits neuronal reuptake of serotonin (Ki = 367 nM) and acts as an antagonist at 5-HT-2A (Ki = 35.6 nM) serotonin receptors. Trazodone is also an antagonist at several other monoaminergic receptors including 5-HT2B (Ki = 78.4 nM), 5-HT2C (Ki = 224 nM), α1A (Ki = 153 nM), α2C (Ki = 155 nM) receptors and it is a partial agonist at 5HT1A (Ki = 118 nM) receptor.

Trazodone antagonizes alpha 1-adrenergic receptors, a property which may be associated with postural hypotension.

12.3 Pharmacokinetics


Absorption
In humans, trazodone hydrochloride is absorbed after oral administration without selective localization in any tissue. When trazodone hydrochloride is taken shortly after ingestion of food, there may be an increase in the amount of drug absorbed, a decrease in maximum concentration and a lengthening in the time to maximum concentration. Peak plasma levels occur approximately one hour after dosing when trazodone hydrochloride is taken on an empty stomach or 2 hours after dosing when taken with food.

Metabolism
In vitro studies in human liver microsomes show that trazodone is metabolized, via oxidative cleavage, to an active metabolite, mchlorophenylpiperazine (mCPP) by CYP3A4. Other metabolic pathways that may be involved in the metabolism of trazodone have not been well characterized. Trazodone is extensively metabolized; less than 1% of an oral dose is excreted unchanged in the urine.

Elimination
In some patients trazodone may accumulate in the plasma.

Protein Binding
Trazodone is 89 to 95% protein bound in vitro at concentrations attained with therapeutic doses in humans.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis,Mutagenesis,Impairment Of Fertility


Carcinogenesis
No drug- or dose-related occurrence of carcinogenesis was evident in rats receiving trazodone in daily oral doses up to 7.3 times the maximum recommended human dose (MRSD) of 400 mg/day on mg/m2 basis.


Mutagenesis
No genotoxicity studies were conducted with trazodone.


Impairment of Fertility
Trazodone has no effect on fertility in rats at doses up to 6 times the MRHD on mg/m2 basis in adolescents.



14 CLINICAL STUDIES

The efficacy and safety of trazodone hydrochloride were established from inpatient and outpatient trials of the trazodone immediate release formulation in the treatment of major depressive disorder.

16 HOW SUPPLIED/STORAGE AND HANDLING


Trazodone Hydrochloride Tablets, USP 50 mg are white to off-white, round, biconvex, uncoated tablets, debossed with ‘J’ and ‘43’ on either side of scoreline (functional) on one side and plain on the other side.
Bottles of 30                                        NDC 13107-079-30
Bottles of 100                                      NDC 13107-079-01
Bottles of 500                                      NDC 13107-079-05
Bottles of 1,000                                   NDC 13107-079-99

Trazodone Hydrochloride Tablets, USP 100 mg
are white to off-white, round, biconvex, uncoated tablets, debossed with ‘J’ and ‘44’ on either side of scoreline (functional) on one side and plain on the other side.
Bottles of 30                                       NDC 13107-080-30
Bottles of 100                                     NDC 13107-080-01
Bottles of 500                                     NDC 13107-080-05
Bottles of 1,000                                  NDC 13107-080-99

Trazodone Hydrochloride Tablets, USP 150 mg are white to off-white, oval, flat faced, beveled-edge, uncoated tablets with one side scored (functional) with full bisect debossed with ‘J’ and ‘45’ on either side and having two partial trisect on one side and plain on the other side.
Bottles of 20                                      NDC 13107-081-20
Bottles of 100                                    NDC 13107-081-01
Bottles of 500                                    NDC 13107-081-05
Bottles of 1,000                                 NDC 13107-081-99

Directions for using the correct score when breaking the tablet, please refer to the following:
-For 50 mg, break the score on either the left or right side of the tablet (one-third of a tablet).


score1

-For 75 mg, break the score down the middle of the tablet (one-half of a tablet).


score2

-For 100 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet).


score3

-For 150 mg, use the entire tablet.


score4


Trazodone Hydrochloride Tablets, USP 300 mg are white to off-white, oval, flat faced, beveled-edge, uncoated tablets with one side scored (functional) with full bisect debossed with ‘J’ and ‘46’ on either side and having two partial trisect on one side and plain on the other side.
Bottles of 100                                   NDC 13107-082-01
Bottles of 500                                   NDC 13107-082-05
Directions for using the correct score when breaking the tablet, please refer to the following:
-For 100 mg, break the score on either the left or right side of the tablet (one-third of a tablet)


score5

-For 150 mg, break the score down the middle of the tablet (one-half of a tablet).


score6

-For 200 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet).


score7

-For 300 mg, use the entire tablet.


score8

Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15ºC and 30ºC (59°F to 86ºF) [see USP Controlled Room Temperature]. Dispense with a child-resistant closure in a tight, light-resistant container.




17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).


Suicidal Thoughts and Behaviors

Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down and instruct them to report such symptoms to the healthcare provider [see Box Warningand Warnings and Precautions (5.1)].


Dosage and Administration

Advise patients that Trazodone hydrochloride tablets should be taken shortly after a meal or light snack. Advise patients regarding the importance of following dosage titration instructions [see Dosage and Administration (2)].


Serotonin Syndrome

Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of Trazodone hydrochloride tablets with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Patients should contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions (5.2) and Drug Interactions (7)].


Activation of Mania/Hypomania

Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions (5.7)].


Increased Risk of Bleeding

Inform patients about the concomitant use of Trazodone hydrochloride tablets with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use of drugs that interfere with serotonin reuptake and these medications has been associated with an increased risk of bleeding. Advise them to inform their health care providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [see Warnings and Precautions (5.5)].


Discontinuation Syndrome

Advise patients not to abruptly discontinue Trazodone hydrochloride tablets and to discuss any tapering regimen with their healthcare provider. Adverse reactions can occur when Trazodone hydrochloride tablets are discontinued [see Warnings and Precautions (5.8)].


Concomitant Medications

Advise patients to inform their health care providers if they are taking, or plan to take any prescription or over-the-counter medications since there is a potential for interactions [see Drug Interactions (7.1)].

Dispense with Medication Guide available at www.aurobindousa.com/product-medication-guides
 Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Revised: 01/2020

MEDICATION GUIDE

Trazodone Hydrochloride Tablets, USP

(traz' oh done hye'' droeklor' ide)


What is the most important information I should know about Trazodone hydrochloride tablets?
Antidepressant medicines, depression or other serious mental illnesses, and suicidal thoughts or actions: Talk to your healthcare provider about:



1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions.
Some people may have a higher risk of having suicidal thoughts or actions. These include people who have or have a family history of bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
3. How can I watch for and try to prevent suicidal thoughts and actions?



Call a healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:



What else do I need to know about antidepressant medicines?



It is not known if Trazodone hydrochloride tablets are safe and effective in children.

What are Trazodone hydrochloride tablets?
Trazodone hydrochloride tablets are the prescription medicine used in adults to treat major depressive disorder (MDD). Trazodone hydrochloride belongs to a class of medicines known as SSRIs (or selective serotonin reuptake inhibitors).

Do not take Trazodone hydrochloride tablets:



Before you take Trazodone hydrochloride tablets tell your healthcare provider about all of your medical conditions, including if you:



Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using Trazodone hydrochloride tablets with certain other medicines can affect each other causing serious side effects.
Especially tell your healthcare provider if you take:



Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take Trazodone hydrochloride tablets?



What should I avoid while taking Trazodone hydrochloride tablets?



What are the possible side effects of Trazodone hydrochloride tablets?
Trazodone hydrochloride tablets can cause serious side effects or death, including:


              o eye pain

              o changes in vision
              o swelling or redness in or around the eye

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.




Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of Trazodone hydrochloride tablets include:



These are not all the possible side effects of Trazodone hydrochloride tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Trazodone hydrochloride tablets?



Keep Trazodone hydrochloride tablets and all medicines out of the reach of children.
General information about the safe and effective use of Trazodone hydrochloride tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Trazodone hydrochloride tablets for a condition for which it was not prescribed. Do not give Trazodone hydrochloride tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Trazodone hydrochloride tablets that is written for health professionals.

What are the ingredients in Trazodone hydrochloride tablets?
Active ingredient: trazodone hydrochloride, USP
Inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (physically modified corn (maize) starch), sodium lauryl sulfate, and sodium starch glycolate.
This Medication Guide has been approved by the U.S. Food and Drug Administration

Dispense with Medication Guide available at www.aurobindousa.com/product-medication-guides

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Revised: 01/2020

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-50 mg (30 Tablet Bottle)


NDC 13107-079-30

TraZODONE Hydrochloride Tablets, USP


50 mg
Pharmacist:
 "Dispense the Medication Guide provided separately to each patient."
Rx only 30 Tablets


trazodone50mg30ct

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-100 mg (30 Tablet Bottle)

NDC 13107-080-30
TraZODONE Hydrochloride Tablets, USP
100 mg
Pharmacist
: "Dispense the Medication Guide provided separately to each patient."
Rx only 30 Tablets

trazodone100mg30ct


PACKAGE LABEL-PRINCIPAL DISPALY PANEL- 150 mg (20 Tablet Bottle)

NDC 13107-081-20
TraZODONE Hydrochloride Tablets, USP
150 mg
Pharmacist:
"Dispense the Medication Guide provided separately to each patient."
Rx only 20 Tablets

trazodone150mg30ct



PACKAGE LABEL-PRINCIPAL DISPALY PANEL- 300 mg (100 Tablet Bottle)

NDC 13107-082-01
TraZODONE Hydrochloride Tablets, USP
300 mg
Pharmacist
: "Dispense the Medication Guide provided separately to each patient."
Rx only 100 Tablets


trazodone300mg100ct

TRAZODONE HYDROCHLORIDE 
trazodone hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:13107-079
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30) TRAZODONE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITE (white to off-white) Score2 pieces
ShapeROUND (biconvex) Size7mm
FlavorImprint Code J;43
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13107-079-3030 in 1 BOTTLE; Type 0: Not a Combination Product09/15/2015
2NDC:13107-079-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/15/2015
3NDC:13107-079-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/15/2015
4NDC:13107-079-991000 in 1 BOTTLE; Type 0: Not a Combination Product09/15/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20485209/15/2015
TRAZODONE HYDROCHLORIDE 
trazodone hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:13107-080
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30) TRAZODONE HYDROCHLORIDE100 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITE (white to off-white) Score2 pieces
ShapeROUND (biconvex) Size10mm
FlavorImprint Code J;44
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13107-080-3030 in 1 BOTTLE; Type 0: Not a Combination Product09/15/2015
2NDC:13107-080-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/15/2015
3NDC:13107-080-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/15/2015
4NDC:13107-080-991000 in 1 BOTTLE; Type 0: Not a Combination Product09/15/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20485209/15/2015
TRAZODONE HYDROCHLORIDE 
trazodone hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:13107-081
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30) TRAZODONE HYDROCHLORIDE150 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITE (white to off-white) Score3 pieces
ShapeOVAL (biconvex) Size17mm
FlavorImprint Code J;45
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13107-081-2020 in 1 BOTTLE; Type 0: Not a Combination Product09/15/2015
2NDC:13107-081-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/15/2015
3NDC:13107-081-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/15/2015
4NDC:13107-081-991000 in 1 BOTTLE; Type 0: Not a Combination Product09/15/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20485209/15/2015
TRAZODONE HYDROCHLORIDE 
trazodone hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:13107-082
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30) TRAZODONE HYDROCHLORIDE300 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITE (white to off-white) Score3 pieces
ShapeOVAL (biconvex) Size21mm
FlavorImprint Code J;46
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13107-082-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/15/2015
2NDC:13107-082-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/15/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20485209/15/2015
Labeler - Aurolife Pharma, LLC (829084461)
Establishment
NameAddressID/FEIBusiness Operations
Aurolife Pharma, LLC829084461MANUFACTURE(13107-079, 13107-080, 13107-081, 13107-082)

Revised: 5/2019
Document Id: f354689f-fd35-4a91-9658-a9055e7b2382
Set id: 295e92a9-bcb0-4d53-ba62-e30020e9834b
Version: 2
Effective Time: 20190528
 
Aurolife Pharma, LLC