Label: DEXAMETHASONE SODIUM PHOSPHATE- dexamethasone sodium phosphate injection, solution

  • NDC Code(s): 63323-506-00, 63323-506-01, 63323-506-03, 63323-506-13, view more
    63323-516-01, 63323-516-10
  • Packager: Fresenius Kabi USA, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 16, 2024

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    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 chemically is Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17-dihydroxy-16-methyl-21-(phosphonooxy)-, disodium salt, (11ß, 16α).

    It occurs as a white to creamy white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.0 and 8.5. It has the following structural formula:

    Structural Formula

    Each mL of Dexamethasone Sodium Phosphate Injection, USP (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.

    Each mL Dexamethasone Sodium Phosphate Injection, USP (Preserved) contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 13.5 mg sodium citrate, dihydrate; 10 mg benzyl alcohol; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5.

  • ACTIONS

    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

    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 (IV only; IM 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. Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used.

    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.

    Children who are on immunosuppressant drugs are more susceptible to infections than healthy children. Chickenpox and measles, for example, can have a more serious or even fatal course in children on immunosuppressant corticosteroids. In such children or in adults who have not had these diseases, particular care should be taken to avoid exposure. If exposed, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.

    Similarly, corticosteroids 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.

    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.

    The use of dexamethasone sodium phosphate injection in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate anti-tuberculosis regimen.

    If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.

    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.

  • 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 Fresenius Kabi USA, LLC at 1-800-551-7176 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 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 4–8 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 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 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 (Preservative Free) equivalent to 10 mg dexamethasone phosphate, is supplied as follows:

    Product CodeUnit of SaleStrengthEach
    RF500601 NDC 63323-506-13
    Unit of 25
    10 mg per mL NDC 63323-506-03
    1 mL Single Dose Vial
    This product contains an RFID.
    500601 NDC 63323-506-01
    Unit of 25
    10 mg per mL NDC 63323-506-00
    1 mL Single Dose Vial

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

    Product CodeUnit of SaleStrengthEach
    501610 NDC 63323-516-10
    Unit of 10
    100 mg per 10 mL
    (10 mg per mL)
    NDC 63323-516-01
    10 mL Multiple Dose Vial

    This container closure is not made with natural rubber latex.

    Storage

    Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Sensitive to heat. Do not autoclave.

    Protect from freezing.

    Protect from light.

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

    Multiple dose vials–Store in container until contents are used.

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    Revised: May 2024

  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL - PRINCIPAL DISPLAY - Dexamethasone 1 mL Vial Label

    NDC 63323-506-03         RF500601

    DEXAMETHASONE

    SODIUM PHOSPHATE

    INJECTION, USP

    10 mg per mL

    For IV or IM Use Only Rx only

    1 mL Single Dose Vial

    Preservative Free

    Discard unused portion

    PROTECT FROM LIGHT.

    PACKAGE LABEL - PRINCIPAL DISPLAY - Dexamethasone 1 mL Vial Label
  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL - PRINCIPAL DISPLAY - Dexamethasone 1 mL Tray Label

    NDC 63323-506-13         RF500601

    DEXAMETHASONE

    SODIUM PHOSPHATE

    INJECTION, USP

    10 mg per mL*

    For Intravenous or

    Intramuscular Use Only

    Rx only

    25 x 1 mL

    Single Dose Vials

    PACKAGE LABEL - PRINCIPAL DISPLAY - Dexamethasone 1 mL Tray Label
  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL - PRINCIPAL DISPLAY - Dexamethasone 1 mL Vial Label

    NDC 63323-506-00         500601

    DEXAMETHASONE

    SODIUM PHOSPHATE

    INJECTION, USP

    10 mg per mL

    For IV or IM Use Only Rx only

    1 mL Single Dose Vial

    Preservative Free

    Discard unused portion

    PROTECT FROM LIGHT.

    PACKAGE LABEL - PRINCIPAL DISPLAY - Dexamethasone 1 mL Vial Label
  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL - PRINCIPAL DISPLAY - Dexamethasone 1 mL Tray Label

    NDC 63323-506-01         500601

    DEXAMETHASONE

    SODIUM PHOSPHATE

    INJECTION, USP

    10 mg per mL*

    For Intravenous or

    Intramuscular Use Only

    Rx only

    25 x 1 mL

    Single Dose Vials

    PACKAGE LABEL - PRINCIPAL DISPLAY - Dexamethasone 1 mL Tray Label
  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL - PRINCIPAL DISPLAY - Dexamethasone 10 mL Vial Label

    NDC 63323-516-01         501610

    DEXAMETHASONE

    SODIUM PHOSPHATE

    INJECTION, USP

    100 mg per 10mL

    (10 mg per mL*)

    For Intravenous or

    Intramuscular Use

    Rx only

    10 mL Multiple Dose Vial

    PACKAGE LABEL - PRINCIPAL DISPLAY - Dexamethasone 10 mL Vial Label
  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL - PRINCIPAL DISPLAY - Dexamethasone 10 mL Tray Label

    NDC 63323-516-10         501610

    DEXAMETHASONE

    SODIUM PHOSPHATE

    INJECTION, USP

    100 mg per 10mL

    (10 mg per mL*)

    For Intravenous or

    Intramuscular Use

    Rx only

    10 x 10 mL Multiple Dose Vials

    PACKAGE LABEL - PRINCIPAL DISPLAY - Dexamethasone 10 mL Tray Label
  • INGREDIENTS AND APPEARANCE
    DEXAMETHASONE SODIUM PHOSPHATE  
    dexamethasone sodium phosphate injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63323-506
    Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXAMETHASONE SODIUM PHOSPHATE (UNII: AI9376Y64P) (DEXAMETHASONE - UNII:7S5I7G3JQL) DEXAMETHASONE PHOSPHATE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CITRATE (UNII: 1Q73Q2JULR) 24.75 mg  in 1 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63323-506-0125 in 1 TRAY05/29/2003
    1NDC:63323-506-001 mL in 1 VIAL; Type 0: Not a Combination Product
    2NDC:63323-506-1325 in 1 TRAY01/06/2025
    2NDC:63323-506-031 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04049105/29/2003
    DEXAMETHASONE SODIUM PHOSPHATE  
    dexamethasone sodium phosphate injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63323-516
    Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXAMETHASONE SODIUM PHOSPHATE (UNII: AI9376Y64P) (DEXAMETHASONE - UNII:7S5I7G3JQL) DEXAMETHASONE PHOSPHATE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CITRATE (UNII: 1Q73Q2JULR) 13.5 mg  in 1 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 10 mg  in 1 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63323-516-1010 in 1 TRAY04/05/2005
    1NDC:63323-516-0110 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04057204/05/2005
    Labeler - Fresenius Kabi USA, LLC (608775388)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fresenius Kabi USA, LLC840771732analysis(63323-506, 63323-516) , manufacture(63323-506, 63323-516)