DEXAMETHASONE SODIUM PHOSPHATE - dexamethasone sodium phosphate injection 
Gland Pharma Limited

----------

DEXAMETHASONE SODIUM PHOSPHATE - dexamethasone sodium phosphate injection, Solution
Dexamethasone Sodium Phosphate Injection
Rx only

DESCRIPTION


Dexamethasone Sodium Phosphate Injection, USP is a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly.



Dexamethasone Sodium Phosphate, USP C22H28FNa2O8P, has a molecular weight of 516.4 and chemically is 9-fluoro-11β, 17, 21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione, 21-(dihydrogen phosphate) disodium salt.
It occurs as a white to practically white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.5 and 9.5. It has the following structural formula:

dexa-structure

Dexamethasone Sodium Phosphate Injection, USP is available in 4 mg/mL and 10 mg/mL concentrations.


Each mL of Dexamethasone Sodium Phosphate Injection USP, 4 mg/mL contains dexamethasone sodium phosphate, USP equivalent to 4 mg of dexamethasone phosphate; 11 mg sodium citrate anhydrous; 1 mg sodium sulfite; 10 mg benzyl alcohol (preservative); water for injection, q.s. NaOH and/or citric acid monohydrate to adjust pH if necessary.


Each mL of Dexamethasone Sodium Phosphate Injection USP, 10 mg/mL (Preservative Free) contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 24.75 mg sodium citrate, dihydrate; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5.


CLINICAL PHARMACOLOGY


Naturally occurring glucocorticoids (hydrocortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.

Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli.

INDICATIONS AND USAGE


A. Intravenous or intramuscular administration
When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows:



1.  Endocrine Disorders
Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). 
Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). 
Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected.
Congenital adrenal hyperplasia
Nonsuppurative thyroiditis
Hypercalcemia associated with cancer


2.  Rheumatic Disorders


As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
Post-traumatic osteoarthritis
Synovitis of osteoarthritis
Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy).
Acute and subacute bursitis
Epicondylitis
Acute nonspecific tenosynovitis
Acute gouty arthritis
Psoriatic arthritis
Ankylosing spondylitis


3. Collagen Diseases

 During an exacerbation or as maintenance therapy in selected cases of:


Systemic lupus erythematosus
Acute rheumatic carditis



4.  Dermatologic Diseases
Pemphigus
Severe erythema multiforme (Stevens-Johnson syndrome)
Exfoliative dermatitis
Bullous dermatitis herpetiformis
Severe seborrheic dermatitis
Severe psoriasis
Mycosis fungoides


5. Allergic States


Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in:
Bronchial asthma
Contact dermatitis
Atopic dermatitis
Serum sickness
Seasonal or perennial allergic rhinitis
Drug hypersensitivity reactions
Urticarial transfusion reactions
Acute noninfectious laryngeal edema (epinephrine is the drug of first choice)



6. Ophthalmic Diseases
Severe acute and chronic allergic and inflammatory processes involving the eye, such as:
Herpes zoster ophthalmicus
Iritis, iridocyclitis
Chorioretinitis
Diffuse posterior uveitis and choroiditis
Optic neuritis
Sympathetic ophthalmia
Anterior segment inflammation
Allergic conjunctivitis
Allergic corneal marginal ulcers
Keratitis



7. Gastrointestinal Diseases
To tide the patient over a critical period of the disease in:
Ulcerative colitis (systemic therapy)
Regional enteritis (systemic therapy)



8. Respiratory Diseases
Symptomatic sarcoidosis
Berylliosis
Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate anti-tuberculosis chemotherapy
Loeffler’s syndrome not manageable by other means
Aspiration pneumonitis


9. Hematologic Disorders


Acquired (autoimmune) hemolytic anemia
Idiopathic thrombocytopenic purpura in adults (I.V. only; I.M. administration is contraindicated)
Secondary thrombocytopenia in adults
Erythroblastopenia (RBC anemia)
Congenital (erythroid) hypoplastic anemia


10. Neoplastic Diseases
For palliative management of:
Leukemias and lymphomas in adults
Acute leukemia of childhood



11. Edematous States

To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus



12.  Nervous System
Acute exacerbations of multiple sclerosis



13. Miscellaneous.
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculosis chemotherapy.
Trichinosis with neurologic or myocardial involvement
Diagnostic testing of adrenocortical hyperfunction
Cerebral edema of diverse etiologies in conjunction with adequate neurological evaluation and management



B. Intra-articular or soft tissue administration
When the strength and dosage form of the drug lend the preparation to the treatment of the condition, those products labeled for intra-articular or soft tissue administration are indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
Synovitis of osteoarthritis.
Rheumatoid arthritis.
Acute and subacute bursitis.
Acute gouty arthritis.
Epicondylitis.
Acute nonspecific tenosynovitis.
Post-traumatic osteoarthritis.



C. Intralesional administration.
When the strength and dosage form of the drug lend the preparation to the treatment of the condition, those products labeled for intralesional administration are indicated for:
Keloids.
Localized hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques,granuloma annulare, and lichen simplex chronicus (neurodermatitis).
Discoid lupus erythematosus.
Necrobiosis lipoidica diabeticorum.
Alopecia areata.
They also may be  useful in cystic tumors of an aponeurosis tendon (ganglia).

CONTRAINDICATIONS


Systemic fungal infections.

WARNINGS


Serious Neurologic Adverse Reactions with Epidural Administration
Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy. The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use.



In patients on corticosteroid therapy subject to any unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated.


Immunosuppression and Increased Risk of Infection
Corticosteroids, including dexamethasone sodium phosphate injection, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can:

Corticosteroid-associated infections can be mild but can be severe and at times fatal. The rate of infectious complications increases with increasing corticosteroid dosages.

Monitor for the development of infection and consider dexamethasone sodium phosphate injection withdrawal or dosage reduction as needed.

Tuberculosis
If dexamethasone sodium phosphate injection is used to treat a condition in patients with latent tuberculosis or tuberculin reactivity, tuberculosis may occur. Closely monitor such patients for reactivation. During prolonged therapy, patients with latent tuberculosis or tuberculin reactivity should receive chemoprophylaxis.

Varicella Zoster and Measles Viral Infections
Varicella and measles can have a serious or even fatal course in non-immune patients taking corticosteroids, including dexamethasone sodium phosphate injection. In corticosteroid-treated patients who have not had these diseases or are non-immune, particular care should be taken to avoid exposure to varicella and measles:

Hepatitis B Virus Reactivation
Hepatitis B virus reactivation can occur in patients who are hepatitis B carriers treated with immunosuppressive dosages of corticosteroids, including dexamethasone sodium phosphate injection. Reactivation can also occur infrequently in corticosteroid-treated patients who appear to have resolved hepatitis B infection.

Screen patients for hepatitis B infection before initiating immunosuppressive (e.g., prolonged) treatment with dexamethasone sodium phosphate injection. For patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding monitoring and consideration for hepatitis B antiviral therapy.

Fungal Infections
Corticosteroids, including dexamethasone sodium phosphate injection, may exacerbate systemic fungal infections; therefore, avoid dexamethasone sodium phosphate injection use in the presence of such infections unless dexamethasone sodium phosphate injection is needed to control drug reactions. For patients on chronic dexamethasone sodium phosphate injection therapy who develop systemic fungal infections, dexamethasone sodium phosphate injection withdrawal or dosage reduction is recommended.

Amebiasis
Corticosteroids, including dexamethasone sodium phosphate injection, may activate latent amebiasis. Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating dexamethasone sodium phosphate injection in patients who have spent time in the tropics or patients with unexplained diarrhea.

Strongyloides Infestation
Corticosteroids, including dexamethasone sodium phosphate injection, should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.

Cerebral Malaria
Avoid corticosteroids, including dexamethasone sodium phosphate injection, in patients with cerebral malaria.

Kaposi’s Sarcoma
Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement of Kaposi’s sarcoma.



Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.


Usage in Pregnancy


Since adequate human reproduction studies have not been done with corticosteroids, use of these drugs in pregnancy, nursing mothers or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.



Average and large doses of cortisone or hydrocortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Patients with a stressed myocardium should be observed carefully and the drug administered slowly since premature ventricular contractions may occur with rapid administration. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.

While on corticosteroid therapy patients should not be vaccinated against smallpox. Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially in high doses, because of possible hazards of neurological complications and lack of antibody response.

Because rare instances of anaphylactoid reactions have occurred in patients receiving parenteral corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug.


Dexamethasone sodium phosphate injection, 4 mg/mL contains sodium sulfite, a sulfite that may cause allergic type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

PRECAUTIONS


Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.

There is an enhanced effect of corticosteroids in patients with hypothyroidism and in those with cirrhosis.

Corticosteroids should be used cautiously in patients with ocular herpes simplex for fear of corneal perforation.

The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction must be gradual.

Psychic derangements may appear when corticosteroids are used ranging from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.

Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.

Steroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess or other pyogenic infection, also in diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, and myasthenia gravis. 
Growth and development of infants and children on prolonged corticosteroid therapy should be carefully followed.

Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to obtain medical advice.

Intra-articular injection of a corticosteroid may produce systemic as well as local effects.

Appropriate examination of any joint fluid present is necessary to exclude a septic process.

A marked increase in pain accompanied by local swelling, further restriction of joint motion, fever, and malaise are suggestive of septic arthritis. If this complication occurs and the diagnosis of sepsis is confirmed, appropriate antimicrobial therapy should be instituted.

Local injection of a steroid into a previously infected joint is to be avoided. Corticosteroids should not be injected into unstable joints.

Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis they do not show that they affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See Dosage and Administration Section).

Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used.

ADVERSE REACTIONS


To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at (609) 250-7990 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch


 
Fluid and electrolyte disturbances:



Sodium retention
Fluid retention
Congestive heart failure in susceptible patients
Potassium loss
Hypokalemic alkalosis
Hypertension



Musculoskeletal:



Muscle weakness
Steroid myopathy
Loss of muscle mass
Osteoporosis
Vertebral compression fractures
Aseptic necrosis of femoral and humeral heads
Pathologic fracture of long bones



Gastrointestinal:



Peptic ulcer with possible subsequent perforation and hemorrhage
Pancreatitis
Abdominal distention
Ulcerative esophagitis



Dermatological:
 
Impaired wound healing
Thin fragile skin
Facial erythema
Increased sweating
May suppress reactions to skin tests
Petechiae and ecchymoses

Neurological:



Convulsions
Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment
Vertigo
Headache
Ophthalmic:
Posterior subcapsular cataracts
Increased intraocular pressure
Glaucoma



Endocrine:



Menstrual irregularities
Development of cushingoid state
Suppression of growth in children
Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery, or illness
Decreased carbohydrate tolerance
Manifestations of latent diabetes mellitus
Increased requirements for insulin or oral hypoglycemic agents in diabetics



Metabolic:
Negative nitrogen balance due to protein catabolism
Miscellaneous:
Hyperpigmentation or hypopigmentation
Subcutaneous and cutaneous atrophy
Sterile abscess
Post-injection flare, following intra-articular use
Charcot-like arthropathy
Itching, burning, tingling in the ano-genital region

DOSAGE AND ADMINISTRATION


A. Intravenous or Intramuscular Administration:
The initial dosage of dexamethasone sodium phosphate injection, USP may vary from 0.50 mg/day to 9.0 mg/day depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice while in selected patients higher initial doses may be required. Usually the parenteral dosage ranges are one-third to one-half the oral dose given every 12 hours. However, in certain overwhelming, acute, life-threatening situations, administration of dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages.

For the treatment of unresponsive shock high pharmacologic doses of this product are currently recommended. Reported regimens range from 1 to 6 mg/kg of body weight as a single intravenous injection to 40 mg initially followed by repeat intravenous injection every 2 to 6 hours while shock persists.

For the treatment of cerebral edema in adults an initial intravenous dose of 10 mg is recommended followed by 4 mg intramuscularly every six hours until maximum response has been noted. This regimen may be continued for several days postoperatively in patients requiring brain surgery. Oral dexamethasone, 1 to 3 mg t.i.d., should be given as soon as possible and dosage tapered off over a period of five to seven days. Nonoperative cases may require continuous therapy to remain free of symptoms of increased intracranial pressure. The smallest effective dose should be used in children, preferably orally. This may approximate 0.2 mg/kg/24 hours in divided doses.



In treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day or 4 to 8 mg dexamethasone every other day for 1 month have been shown to be effective.

The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, dexamethasone sodium phosphate injection, USP should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient.

After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this later situation it may be necessary to increase the dosage of dexamethasone sodium phosphate injection, USP for a period of time consistent with the patient’s condition. If after a long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

B. Intra-articular, soft tissue or intralesional administration. 
The dose for intrasynovial administration is usually 2 to 4 mg for large joints and 0.8 to 1 mg for small joints. For soft tissue and bursal injections a dose of 2 to 4 mg is recommended. Ganglia require a dose of 1 to 2 mg. A dose of 0.4 to 1 mg is used for injection into tendon sheaths. Injection into intervertebral joints should not be attempted at any time and hip joint injection cannot be recommended as an office procedure.

Intrasynovial and soft tissue injections should be employed only when affected areas are limited to 1 or 2 sites. It should be remembered that corticoids provide palliation only and that other conventional or curative methods of therapy should be employed when indicated.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.


Frequency of injection usually ranges from once every 3 to 5 days to once every 2 to 3 weeks. Frequent intra-articular injection may cause damage to joint tissue.

HOW SUPPLIED

Dexamethasone Sodium Phosphate Injection USP, 4 mg/mL, is a sterile, clear colorless to almost colorless solution free from foreign visible particles supplied as;


 Unit of Sale

 Strength

 Each

 NDC 68083-473-25 

 4 mg/mL

  Carton of 25 single-dose vials

 NDC 68083-474-25 

 20 mg/5 mL (4 mg/mL) 

  Carton of 25 multiple-dose vials


Dexamethasone Sodium Phosphate Injection, USP (Preservative Free) equivalent to 10 mg dexamethasone phosphate, is supplied as follows:


Unit of Sale
Strength
Each
NDC 68083-607-25
25 Vials in One Carton
10 mg per mL
1 mL single dose vial

This container closure is not made with natural rubber latex.


Storage

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


Protect from light.

Single dose vials–Store in container until time of use. Discard unused portion.


Manufactured by:
Gland Pharma Limited
Pashamylaram, Patancheru,
Hyderabad – 502 307, India


Revised: February 2024


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dexamethasone-10mg-spl-container-label-1mlContainer Label:

NDC 68083-473-01      Rx Only

Dexamethasone

Sodium Phosphate

Injection, USP

4 mg per mL 

1 mL

Dexa-4mg-Container-Label-1mL

Carton Label:

NDC 68083-473-25       25 x 1 mL Single Dose Vials

Dexamethasone Sodium Phosphate

Injection, USP

4 mg per mL

Rx Only

Dexa-4mg-Carton-label-1mL


 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Label:

NDC 68083-474-01         Rx Only

Dexamethasone

Sodium Phosphate

Injection, USP

20 mg per 5 mL

(4 mg per mL)  
5 mL

Dexa-4mg-Container-Label-5mL

Carton Label:

NDC 68083-474-25         25 x 5 mL Multiple Dose Vial

Dexamethasone Sodium Phosphate

Injection, USP

20 mg per 5 mL

(4 mg per mL)  

Rx Only

Dexa-4mg-Carton-Label-5mL


Container Label:

NDC 68083-607-01      Rx Only

Dexamethasone

Sodium Phosphate

Injection, USP

10 mg per mL 

(Dexamethasone Phosphate Equivalent)

For Intravenous or Intramuscular Use*

1 mL Single Dose Vial

dexa-10mg-container-label-1ml


Carton Label:

NDC 68083-607-25      Rx only

Dexamethasone Sodium Phosphate

Injection, USP

10 mg per mL*

(Dexamethasone Phosphate Equivalent)

For Intravenous, Intramuscular, Intraarticular,
Soft Tissue, or Intralesional Use

25 x 1 mL Single Dose Vials

 

dexa-10mg-carton-label-1ml


DEXAMETHASONE SODIUM PHOSPHATE 
dexamethasone sodium phosphate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68083-473
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, INTRA-ARTICULAR, SOFT TISSUE, INTRALESIONAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXAMETHASONE SODIUM PHOSPHATE (UNII: AI9376Y64P) (DEXAMETHASONE - UNII:7S5I7G3JQL) DEXAMETHASONE4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA) 11 mg  in 1 mL
SODIUM SULFITE (UNII: VTK01UQK3G) 1 mg  in 1 mL
BENZYL ALCOHOL (UNII: LKG8494WBH) 10 mg  in 1 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68083-473-2525 in 1 CARTON08/04/2021
1NDC:68083-473-011 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21565408/04/2021
DEXAMETHASONE SODIUM PHOSPHATE 
dexamethasone sodium phosphate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68083-474
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, INTRA-ARTICULAR, SOFT TISSUE, INTRALESIONAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXAMETHASONE SODIUM PHOSPHATE (UNII: AI9376Y64P) (DEXAMETHASONE - UNII:7S5I7G3JQL) DEXAMETHASONE4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA) 11 mg  in 1 mL
SODIUM SULFITE (UNII: VTK01UQK3G) 1 mg  in 1 mL
BENZYL ALCOHOL (UNII: LKG8494WBH) 10 mg  in 1 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68083-474-2525 in 1 CARTON08/04/2021
1NDC:68083-474-015 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21565408/04/2021
DEXAMETHASONE SODIUM PHOSPHATE 
dexamethasone sodium phosphate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68083-607
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, INTRA-ARTICULAR, SOFT TISSUE, INTRALESIONAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXAMETHASONE SODIUM PHOSPHATE (UNII: AI9376Y64P) (DEXAMETHASONE - UNII:7S5I7G3JQL) DEXAMETHASONE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) 24.75 mg  in 1 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68083-607-2525 in 1 CARTON09/25/2023
1NDC:68083-607-011 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21565409/25/2023
Labeler - Gland Pharma Limited (918601238)
Establishment
NameAddressID/FEIBusiness Operations
Gland Pharma Limited858971074ANALYSIS(68083-473, 68083-474, 68083-607) , MANUFACTURE(68083-473, 68083-474, 68083-607) , PACK(68083-473, 68083-474, 68083-607)

Revised: 2/2024
Document Id: 3c8c9396-8347-4c98-8c98-da4da90bc4d3
Set id: c9d9ab76-6bc6-433d-aad7-8d49064ed745
Version: 6
Effective Time: 20240222
 
Gland Pharma Limited