Label: PHENTERMINE RESIN ER- phentermine capsule, extended release

  • NDC Code(s): 0527-1366-01, 0527-1398-01
  • Packager: Lannett Company, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIV
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 01/13

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use phentermine resin extended-release capsules safely and effectively. See full prescribing information for phentermine resin extended-release capsules.

    PHENTERMINE Resin Extended-Release Capsules CIV
    Initial U.S. Approval: 1959

    INDICATIONS AND USAGE

    Phentermine resin extended-release capsules are a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (1)

    The limited usefulness of agents of this class, including phentermine, should be measured against possible risk factors inherent in their use. (1)

    DOSAGE AND ADMINISTRATION

    • Dosage should be individualized to obtain an adequate response with the lowest effective dose. (2)
    • One capsule daily, before breakfast or 10-14 hours before retiring. (2)
    • Late evening administration should be avoided (risk of insomnia). (2)
    • Phentermine resin extended-release capsules can be taken with or without food (12.3)

    DOSAGE FORMS AND STRENGTHS

    • Capsules containing cationic resin complex equivalent to 15 mg or 30 mg phentermine base.

    CONTRAINDICATIONS

    • History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension) (4)
    • During or within 14 days following the administration of monoamine oxidase inhibitors (4)
    • Hyperthyroidism (4)
    • Glaucoma (4)
    • Agitated states (4)
    • History of drug abuse (4)
    • Pregnancy (4, 8.1)
    • Nursing (4, 8.3)
    • Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines (4)

    WARNINGS AND PRECAUTIONS

    • Coadministration with other drugs for weight loss is not recommended (safety and efficacy of combination not established). (5.1)
    • Rare cases of primary pulmonary hypertension have been reported. Phentermine should be discontinued in case of new, unexplained symptoms of dyspnea, angina pectoris, syncope or lower extremity edema. (5.2)
    • Rare cases of serious regurgitant cardiac valvular disease have been reported. (5.3)
    • Tolerance to the anorectic effect usually develops within a few weeks. If this occurs, phentermine should be discontinued. The recommended dose should not be exceeded. (5.4)
    • Phentermine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle. (5.5)
    • Risk of abuse and dependence. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. (5.6)
    • Concomitant alcohol use may result in an adverse drug reaction. (5.7)
    • Use caution in patients with even mild hypertension (risk of increase in blood pressure). (5.8)
    • A reduction in dose of insulin or oral hypoglycemic medication may be required in some patients. (5.9)

    ADVERSE REACTIONS

    Adverse events have been reported in the cardiovascular, central nervous, gastrointestinal, allergic, and endocrine systems. (6)

    To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-800-325-9994 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    DRUG INTERACTIONS

    • Monoamine oxidase inhibitors: Risk of hypertensive crisis. (4, 7.1)
    • Alcohol: Consider potential interaction (7.2)
    • Insulin and oral hypoglycemics: Requirements may be altered. (7.3)
    • Adrenergic neuron blocking drugs: Hypotensive effect may be decreased by phentermine. (7.4)

    USE IN SPECIFIC POPULATIONS

    • Nursing mothers: Discontinue drug or nursing taking into consideration importance of drug to mother. (48.3)
    • Pediatric use: Safety and effectiveness not established. (8.4)
    • Geriatric use: Due to substantial renal excretion, use with caution. (8.5)
    • Use caution when administering phentermine to patients with renal impairment (8.6)

    See 17 for PATIENT COUNSELING INFORMATION.

    Revised: 1/2013

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  • FULL PRESCRIBING INFORMATION: CONTENTS*
  • 1 INDICATIONS AND USAGE

    Phentermine resin extended-release capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).

    Below is a chart of body mass index (BMI) based on various heights and weights.

    BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters.

    BODY MASS INDEX (BMI), kg/m2
    Height (feet, inches) 

    Weight
    (pounds)

    5’0”

    5’3”

    5’6”

    5’9”

    6’0”

    6’3”

    140

    27

    25

    23

    21

    19

    18

    150

    29

    27

    24

    22

    20

    19

    160

    31

    28

    26

    24

    22

    20

    170

    33

    30

    28

    25

    23

    21

    180

    35

    32

    29

    27

    25

    23

    190

    37

    34

    31

    28

    26

    24

    200

    39

    36

    32

    30

    27

    25

    210

    41

    37

    34

    31

    29

    26

    220

    43

    39

    36

    33

    30

    28

    230

    45

    41

    37

    34

    31

    29

    240

    47

    43

    39

    36

    33

    30

    250

    49

    44

    40

    37

    34

    31

    The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.

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  • 2 DOSAGE AND ADMINISTRATION

    Exogenous Obesity

    One capsule daily, before breakfast or 10-14 hours before retiring. For individuals exhibiting greater drug responsiveness, phentermine resin extended-release capsules, 15 mg, will usually suffice. Phentermine resin extended-release capsules, 30 mg, are recommended for less responsive patients. Phentermine resin extended-release capsules are not recommended for use in pediatric patients under 16 years of age.

    Phentermine resin extended-release capsules should be swallowed whole.

    Late evening medication should be avoided because of the possibility of resulting insomnia.

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  • 3 DOSAGE FORMS AND STRENGTHS

    Phentermine Resin Extended-Release Capsules are available in two strengths:

    15 mg: Size #3 grey opaque/maize opaque capsules, imprinted with “LCI” on the cap and “1398” on the body.

    30 mg: Size #3 maize/maize capsules, imprinted with “LCI” on the cap and “1366” on the body.

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  • 4 CONTRAINDICATIONS

    • History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension)
    • During or within 14 days following the administration of monoamine oxidase inhibitors
    • Hyperthyroidism
    • Glaucoma
    • Agitated states
    • History of drug abuse
    • Pregnancy [see Use in Specific Populations (8.1)]
    • Nursing [see Use in Specific Populations (8.3)]
    • Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines
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  • 5 WARNINGS AND PRECAUTIONS

    5.1 Coadministration with Other Drug Products for Weight Loss

    Phentermine resin extended-release capsules are indicated only as short-term (a few weeks) monotherapy for the management of exogenous obesity. The safety and efficacy of combination therapy with phentermine and any other drug products for weight loss including prescribed drugs, over-the-counter preparations, and herbal products, or serotonergic agents such as selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. Therefore, coadministration of phentermine and these drug products is not recommended.

    5.2 Primary Pulmonary Hypertension

    Primary Pulmonary Hypertension (PPH) - a rare, frequently fatal disease of the lungs - has been reported to occur in patients receiving a combination of phentermine with fenfluramine or dexfenfluramine. The possibility of an association between PPH and the use of phentermine alone cannot be ruled out; there have been rare cases of PPH in patients who reportedly have taken phentermine alone. The initial symptom of PPH is usually dyspnea. Other initial symptoms may include angina pectoris, syncope or lower extremity edema. Patients should be advised to report immediately any deterioration in exercise tolerance. Treatment should be discontinued in patients who develop new, unexplained symptoms of dyspnea, angina pectoris, syncope or lower extremity edema, and patients should be evaluated for the possible presence of pulmonary hypertension.

    5.3 Valvular Heart Disease

    Serious regurgitant cardiac valvular disease, primarily affecting the mitral, aortic and/or tricuspid valves, has been reported in otherwise healthy persons who had taken a combination of phentermine with fenfluramine or dexfenfluramine for weight loss. The possible role of phentermine in the etiology of these valvulopathies has not been established and their course in individuals after the drugs are stopped is not known. The possibility of an association between valvular heart disease and the use of phentermine alone cannot be ruled out; there have been rare cases of valvular heart disease in patients who reportedly have taken phentermine alone.

    5.4 Development of Tolerance, Discontinuation in Case of Tolerance

    When tolerance to the anorectant effect develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued.

    5.5 Effect on the Ability to Engage in Potentially Hazardous Tasks

    Phentermine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly.

    5.6 Risk of Abuse and Dependence

    Phentermine is related chemically and pharmacologically to amphetamine (d- and d/l-amphetamine) and other related stimulant drugs that have been extensively abused. The possibility of abuse of phentermine should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. See Drug Abuse and Dependence (9) and Overdosage (10).

    The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

    5.7 Usage with Alcohol

    Concomitant use of alcohol with phentermine may result in an adverse drug reaction.

    5.8 Use in Patients with Hypertension

    Use caution in prescribing phentermine for patients with even mild hypertension (risk of increase in blood pressure).

    5.9 Use in Patients on Insulin or Oral Hypoglycemic Medications for Diabetes Mellitus

    A reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be required.

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  • 6 ADVERSE REACTIONS

    The following adverse reactions are described, or described in greater detail, in other sections:

    - Primary pulmonary hypertension [see Warnings and Precautions (5.2)]

    - Valvular heart disease [see Warnings and Precautions (5.3)]

    - Effect on the ability to engage in potentially hazardous tasks [see Warnings and Precautions (5.5)]

    - Withdrawal effects following prolonged high dosage administration [see Drug Abuse and Dependence (9.3)]

    The following adverse reactions to phentermine have been identified:

    Cardiovascular

    Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevation of blood pressure, ischemic events.

    Central Nervous System

    Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis.

    Gastrointestinal

    Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances.

    Allergic

    Urticaria.

    Endocrine

    Impotence, changes in libido.

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  • 7 DRUG INTERACTIONS

    7.1 Monoamine Oxidase Inhibitors

    Use of phentermine is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis.

    7.2 Alcohol

    Concomitant use of alcohol with phentermine may result in an adverse drug reaction.

    7.3 Insulin and Oral Hypoglycemic Medications

    Requirements may be altered [see Warnings and Precautions (5.9)].

    7.4 Adrenergic Neuron Blocking Drugs

    Phentermine may decrease the hypotensive effect of adrenergic neuron blocking drugs.

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  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Pregnancy Category X

    Phentermine is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to obligatory weight gain that occurs in maternal tissues during pregnancy. Phentermine has pharmacologic activity similar to amphetamine (d- and d/l-amphetamine) [see Clinical Pharmacology (12.1)]. Animal reproduction studies have not been conducted with phentermine. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

    8.3 Nursing Mothers

    It is not known if phentermine is excreted in human milk; however, other amphetamines are present in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

    8.4 Pediatric Use

    Safety and effectiveness in pediatric patients have not been established. Because pediatric obesity is a chronic condition requiring long-term treatment, the use of this product, approved for short-term therapy, is not recommended.

    8.5 Geriatric Use

    In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

    This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

    8.6 Renal Impairment

    Phentermine was not studied in patients with renal impairment. Based on the reported excretion of phentermine in urine, exposure increases can be expected in patients with renal impairment. Use caution when administering phentermine to patients with renal impairment [see Clinical Pharmacology (12.3)].

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  • 9 DRUG ABUSE AND DEPENDENCE

    9.1 Controlled Substance

    Phentermine is a Schedule IV controlled substance.

    9.2 Abuse

    Phentermine is related chemically and pharmacologically to the amphetamines. Amphetamines and other stimulant drugs have been extensively abused and the possibility of abuse of phentermine should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program.

    9.3 Dependence

    Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage of these drugs to many times than recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. A severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.

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  • 10 OVERDOSAGE

    The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

    10.1 Acute Overdosage

    Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmia, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Overdosage of pharmacologically similar compounds has resulted in fatal poisoning usually terminates in convulsions and coma.

    Management of acute phentermine intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard. Acidification of the urine increases phentermine excretion. Intravenous phentolamine (Regitine®, CIBA) has been suggested on pharmacologic grounds for possible acute, severe hypertension, if this complicates overdosage.

    10.2 Chronic Intoxication

    Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia. See Drug Abuse and Dependence (9.3).

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  • 11 DESCRIPTION

    Phentermine Resin Extended-Release Capsules contain 15 mg and 30 mg respectively of phentermine as the cationic exchange resin complex. Phentermine is α, α-dimethyl phenethylamine (phenyl-tertiarybutylamine).

    Inactive Ingredients: dibasic calcium phosphate, talc, and magnesium stearate. The 15 mg capsule shell consists of D&C Yellow No. 10, FD&C Yellow No. 6, titanium dioxide, gelatin, FD&C Blue No. 1, FD&C Red No. 40, FDA /E172 black iron oxide. The capsule imprinting ink consists of shellac glaze in ethanol, black iron oxide, N-butyl alcohol, propylene glycol, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, ethanol and methanol. The 30 mg capsule shell consists of D&C Yellow No. 10, FD&C Yellow No. 6, titanium dioxide, and gelatin. The capsule imprinting ink consists of shellac glaze in ethanol, black iron oxide, N-butyl alcohol, propylene glycol, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, ethanol and methanol.

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  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    Phentermine is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and d/l-amphetamine). Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics." It has not been established that the primary action of such drugs in treating obesity is one of appetite suppression since other central nervous system actions, or metabolic effects, may also be involved.

    12.2 Pharmacodynamics

    Typical of amphetamines include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for.

    12.3 Pharmacokinetics

    Specific Populations

    Renal Impairment

    Phentermine was not studied in patients with renal impairment. The literature reported cumulative urinary excretion of phentermine under uncontrolled urinary pH conditions is 62%-85%. Exposure increases can be expected in patients with renal impairment. Use caution when administering phentermine to patients with renal impairment.

    Drug Interactions

    In a single-dose study comparing the exposures after oral administration of a combination capsule of 15 mg phentermine and 92 mg topiramate to the exposures after oral administration of a 15 mg phentermine capsule or a 92 mg topiramate capsule, there is no significant topiramate exposure change in the presence of phentermine. However in the presence of topiramate, phentermine Cmax and AUC increase 13% and 42%, respectively.

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  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    Studies have not been performed with phentermine to determine the potential for carcinogenesis, mutagenesis or impairment of fertility.

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  • 14 CLINICAL STUDIES

    In relatively short-term clinical trials, adult obese subjects instructed in dietary management and treated with "anorectic" drugs lost more weight on the average than those treated with placebo and diet.

    The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an "anorectic" drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drugs prescribed, such as the physician-investigator, the population treated and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.

    The natural history of obesity is measured over several years, whereas the studies cited are restricted to a few weeks' duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.

    The bioavailability of phentermine resin extended-release capsules has been studied in humans in which blood levels of phentermine were measured by a gas chromatography method. Blood levels obtained with the 15 mg and 30 mg resin complex formulations indicated slower absorption with a reduced but prolonged peak concentration and without a significant difference in prolongation of blood levels when compared with the same doses of phentermine hydrochloride. The clinical significance of these differences is not known. In clinical trials establishing the efficacy of phentermine resin extended-release capsules, a single daily dose produced an effect comparable to that produced by other regimens of “anorectic” drug therapy.

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  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    Phentermine Resin Extended-Release Capsules are available in two strengths:

    15 mg: Size #3 grey opaque/maize opaque capsules, imprinted with “LCI” on the cap and “1398” on the body, in bottles of 100 capsules (NDC 0527-1398-01).

    30 mg: Size #3 maize/maize capsules, imprinted with “LCI” on the cap and “1366” on the body, in bottles of 100 capsules (NDC 0527-1366-01).

    Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

    Dispense in a tight, well-closed container as defined in the USP, with a child-resistant closure (as required).

    Keep out of the reach of children.

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  • 17 PATIENT COUNSELING INFORMATION

    Patients must be informed that phentermine is a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity, and that coadministration of phentermine with other drugs for weight loss is not recommended [see Indications and Usage (1) and Warnings and Precautions (5.1)].

    Patients must be instructed on how much phentermine to take, and when and how to take it [see Dosage and Administration (3)].

    Advise pregnant women and nursing mothers not to use phentermine [see Use in Specific Populations (8.1, 8.3)].

    Patients must be informed about the risks of use of phentermine (including the risks discussed in Warnings and Precautions), about the symptoms of potential adverse reactions and when to contact a physician and/or take other action. The risks include, but are not limited to:

    • Development of primary pulmonary hypertension [see Warnings and Precautions (5.2)]
    • Development of serious valvular heart disease [see Warnings and Precautions (5.3)]
    • Effects on the ability to engage in potentially hazardous tasks [see Warnings and Precautions (5.5)]
    • The risk of an increase in blood pressure [see Warnings and Precautions (5.8) and Adverse Reactions (6)]
    • The risk of interactions [see Contraindications (4), Warnings and Precautions (5.7, 5.9) and Drug Interactions (7)]

    See also, for example, Adverse Reactions (6) and Use in Specific Populations (8).

    The patients must also be informed about

    • the potential for developing tolerance and actions if they suspect development of tolerance [see Warnings and Precautions (5.4)] and
    • the risk of dependence and the potential consequences of abuse [see Warnings and Precautions (5.6), Drug Abuse and Dependence (9), and Overdosage (10)].

    Tell patients to keep phentermine in a safe place to prevent theft, accidental overdose, misuse or abuse. Selling or giving away phentermine may harm others and is against the law.

    Manufactured by:
    LANNETT COMPANY, INC.
    Philadelphia, PA 19136
    Made in the USA

    Revised 01/2013, Revision 2

    10-001

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  • PRINCIPAL DISPLAY PANEL – 15 mg

    NDC 0527-1398-01

    Lannett

    PHENTERMINE RESIN     CIV
    EXTENDED-RELEASE
    CAPSULES

    15 mg*

    Rx Only

    100 CAPSULES

    phentermine-resin-cap-15mg

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  • PRINCIPAL DISPLAY PANEL – 30 mg

    NDC 0527-1366-01

    Lannett

    PHENTERMINE RESIN     CIV
    EXTENDED-RELEASE
    CAPSULES

    30 mg*

    Rx Only

    100 CAPSULES

    phentermine-resin-capsule-30mg

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  • INGREDIENTS AND APPEARANCE
    PHENTERMINE RESIN  ER
    phentermine resin capsule, extended release
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0527-1398
    Route of Administration ORAL DEA Schedule CIV    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENTERMINE (PHENTERMINE) PHENTERMINE 15 mg
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    TALC  
    MAGNESIUM STEARATE  
    D&C YELLOW NO. 10  
    FD&C YELLOW NO. 6  
    TITANIUM DIOXIDE  
    GELATIN  
    SHELLAC  
    ALCOHOL  
    FERROSOFERRIC OXIDE  
    BUTYL ALCOHOL  
    PROPYLENE GLYCOL  
    FD&C BLUE NO. 2  
    ALUMINUM OXIDE  
    FD&C RED NO. 40  
    FD&C BLUE NO. 1  
    METHYL ALCOHOL  
    Product Characteristics
    Color GRAY, YELLOW (gray opaque/maize opaque capsules) Score no score
    Shape CAPSULE Size 16mm
    Flavor Imprint Code LCI;1398
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0527-1398-01 100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040872 07/28/2011
    PHENTERMINE RESIN  ER
    phentermine resin capsule, extended release
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0527-1366
    Route of Administration ORAL DEA Schedule CIV    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENTERMINE (PHENTERMINE) PHENTERMINE 30 mg
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    TALC  
    MAGNESIUM STEARATE  
    D&C YELLOW NO. 10  
    FD&C YELLOW NO. 6  
    TITANIUM DIOXIDE  
    GELATIN  
    SHELLAC  
    ALCOHOL  
    FERROSOFERRIC OXIDE  
    BUTYL ALCOHOL  
    PROPYLENE GLYCOL  
    FD&C BLUE NO. 2  
    ALUMINUM OXIDE  
    FD&C RED NO. 40  
    FD&C BLUE NO. 1  
    METHYL ALCOHOL  
    Product Characteristics
    Color YELLOW Score no score
    Shape CAPSULE Size 16mm
    Flavor Imprint Code LCI;1366
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0527-1366-01 100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040872 07/28/2011
    Labeler - Lannett Company, Inc. (002277481)
    Establishment
    Name Address ID/FEI Business Operations
    Lannett Company, Inc. 002277481 MANUFACTURE(0527-1398, 0527-1366)
    Establishment
    Name Address ID/FEI Business Operations
    Lannett Company, Inc. 829757603 ANALYSIS(0527-1398, 0527-1366), LABEL(0527-1398, 0527-1366), MANUFACTURE(0527-1398, 0527-1366), PACK(0527-1398, 0527-1366)
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