Dexamethasone Sodium Phosphate 4 mg/mL Injection, Solution, 25 vials — NDC 63323-165-51 (Billing 63323-0165-51)
This is a package of 25 vials of Dexamethasone Sodium Phosphate 4 mg/mL Injection, Solution from Fresenius Kabi USA, LLC, marketed since Sep 2000 and currently FDA-listed.
NDC database record
One package, one record: these facts belong to NDC 63323-165-51 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 63323 labeler · 165 product · 51 package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0363323165024, 0363323165130, 0363323165031, 0363323165116 +1 more
- FDA record last changed
- Jul 24, 2026
Other active recalls for Dexamethasone Sodium Phosphate (different manufacturers) — 2 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 006778
- GCN: 27354
- GPI-14 (Medi-Span): 22100020202005
- HICL (First Databank): 002888
- AHFS class code: 52:08.08.00
- RxCUI (RxNorm): 1116927
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It's a steroid that calms inflammation and immune overreaction. Depending on the product, it treats allergic conditions, skin diseases, hormone disorders and eye conditions. Hemady...
- Follow your prescription label exactly. Tablets and liquid are swallowed, and your prescriber sets the amount based on your condition. Please don't stop suddenly after long use, be...
- Increased appetite, weight gain, trouble sleeping, mood swings, nausea and fluid retention are common. Call your doctor for signs of infection, black stools, vision changes, or sev...
- Some medicines interact with it, including certain antifungals, blood thinners, diabetes medicines, aspirin or NSAIDs, and estrogen products. Check with me before adding anything n...
Patient education
Supplement & herbal interactions
Dexamethasone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 63323-0165-16 63323-165-16 | 25 VIAL in 1 TRAY / 1 mL in 1 VIAL | $0.6735 / mL | $16.84 | 2000-09-07 | — | Active |
| 63323-0165-26 63323-165-26 | 25 VIAL, MULTI-DOSE in 1 TRAY / 5 mL in 1 VIAL, MULTI-DOSE | $0.2381 / mL | $29.77 | 2000-09-07 | — | Active |
| 63323-0165-01 63323-165-01 Main listing | 25 VIAL in 1 TRAY / 1 mL in 1 VIAL | $0.6735 / mL | $16.84 | 2000-09-07 | — | Active |
| 63323-0165-05 63323-165-05 | 25 VIAL, MULTI-DOSE in 1 TRAY / 5 mL in 1 VIAL, MULTI-DOSE | $0.2381 / mL | $29.77 | 2000-09-07 | — | Active |
| 63323-0165-30 63323-165-30 | 1 VIAL, MULTI-DOSE in 1 BOX / 30 mL in 1 VIAL, MULTI-DOSE | $0.6940 / mL | $20.82 | 2000-09-07 | — | Active |
| 63323-0165-51 You're viewing this | 25 VIAL in 1 TRAY / 1 mL in 1 VIAL | — | — | 2025-02-17 | — | Active |
| 63323-0165-53 63323-165-53 | 25 VIAL, MULTI-DOSE in 1 TRAY / 5 mL in 1 VIAL, MULTI-DOSE | — | — | 2025-02-17 | — | Active |
This pack shows little to no recent Medicaid volume — a different pack size carries the largest share of fills. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 63323-0165-16?
What NDC number is used to bill for this package of Dexamethasone Sodium Phosphate 4 mg/mL Injection, Solution?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dexamethasone Sodium Phosphate 4 mg/mL 81565-0202-02 | Phlow | 25 vials | $0.674 | AP | Availability likely | — |
| Dexamethasone Sodium Phosphate 4 mg/mL 51662-1370-01 | HF | 5 ml | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 4 mg/mLthis 63323-0165-51 | Fresenius | 25 vials | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 4 mg/mL 55154-9364-05 | Cardinal | 5 vials | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 4 mg/mL 50090-0414-00 | A-S | 1 vial | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 4 mg/mL 85766-0269-30 | Sportpharm | 1 vial | — | AP | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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10 mg / 1 mL
UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
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UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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11 mg / 1 mL
UNII 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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1 mg / 1 mL
UNII VTK01UQK3G
Sodium sulfite is a salt preservative derived from sulfur. It prevents discoloration and microbial growth in medicines, helping keep products stable during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Fresenius Kabi USA, LLC labeler code 63323
- Cladribine 1 mg/mL Injection NDC 63323-140-10
- Ifosfamide 1 g Injection, Powder, Lyophilized, For Solution NDC 63323-142-10
- Floxuridine 500 mg/5mL Injection, Powder, Lyophilized, For Solution NDC 63323-145-07
- Ketorolac Tromethamine 15 mg/mL Injection, Solution NDC 63323-161-01
- Ketorolac Tromethamine 30 mg/mL Injection, Solution NDC 63323-162-01
- LACTATED RINGERS SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mL Injection, Solution NDC 63323-164-74
- Sodium Phosphates SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 276 mg/mL; 142 mg/mL Injection, Solution NDC 63323-170-05
- Carboplatin 10 mg/mL Injection, Solution NDC 63323-172-60
- Gentamicin 10 mg/mL Injection, Solution NDC 63323-173-02
- Sterile Water 1000 mL/1000mL Injection, Solution NDC 63323-178-76
- Pyridoxine Hydrochloride 100 mg/mL Injection, Solution NDC 63323-180-01
- Folic Acid 5 mg/mL Injection, Solution NDC 63323-184-10
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE: Intravenous or Intramuscular Injection 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: • 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 • 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 • Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Acute rheumatic carditis • Dermatologic Diseases Pemphigus Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Bullous dermatitis herpetiformis Severe seborrheic dermatitis Severe psoriasis Mycosis fungoides • 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) • 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 Keratitis Allergic corneal marginal ulcers • Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis (Systemic therapy) Regional enteritis (Systemic therapy) • Respiratory Diseases Symptomatic sarcoidosis Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Loeffler’s syndrome not manageable by other means Aspiration pneumonitis • 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 • Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood • 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 • Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement • Diagnostic testing of adrenocortical hyperfunction • Cerebral Edema associated with primary or metastatic brain tumor, craniotomy, or head inj… [Excerpted — this section continues on DailyMed.]
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION: Dexamethasone sodium phosphate injection, 4 mg per mL– For intravenous, intramuscular, intra-articular, intralesional, and soft tissue injection. Dexamethasone sodium phosphate injection can be given directly from the vial, or it can be added to Sodium Chloride Injection or Dextrose Injection and administered by intravenous drip. Solutions used for intravenous administration or further dilution of this product should be preservative free when used in the neonate, especially the premature infant.
When it is mixed with an infusion solution, sterile precautions should be observed. Since infusion solutions generally do not contain preservatives, mixtures should be used within 24 hours. DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE AND THE RESPONSE OF THE PATIENT.
Intravenous and Intramuscular Injection: The initial dosage of dexamethasone sodium phosphate injection varies from 0.5 to 9 mg a day depending on the disease being treated. In less severe diseases doses lower than 0.5 mg may suffice, while in severe diseases doses higher than 9 mg may be required. The initial dosage should be maintained or adjusted until the patient’s response is satisfactory.
If a satisfactory clinical response does not occur after a reasonable period of time, discontinue dexamethasone sodium phosphate injection and transfer the patient to other therapy. After a favorable initial response, the proper maintenance dosage should be determined by decreasing the initial dosage in small amounts to the lowest dosage that maintains an adequate clinical response. Patients should be observed closely for signs that might require dosage adjustment, including changes in clinical status resulting from remissions or exacerbations of the disease, individual drug responsiveness, and the effect of stress (e.g., surgery, infection, trauma).
During stress it may be necessary to increase dosage temporarily. If the drug is to be stopped after more than a few days of treatment, it usually should be withdrawn gradually. When the intravenous route of administration is used, dosage usually should be the same as the oral dosage.
In certain overwhelming, acute, life-threatening situations, however, administration in dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages. The slower rate of absorption by intramuscular administration should be recognized. Shock There is a tendency in current medical practice to use high (pharmacologic) doses of corticosteroids for the treatment of unresponsive shock.
The following dosages of dexamethasone sodium phosphate injection have been suggested by various authors: Author Dosage Cavanagh 1 3 mg/kg of body weight per 24 hours by constant intravenous infusion after an initial intravenous injection of 20 mg Dietzman 2 2 to 6 mg/kg of body weight as a single intravenous injection Frank 3 40 mg initially followed by repeat intravenous injection every 4 to 6 hours while shock persists Oaks 4 40 mg initially followed by repeat intravenous injection every 2 to 6 hours while shock persists Schumer 5 1 mg/kg of body weight as a single intravenous injection Administration of high dose corticosteroid therapy should be continued only until the patient’s condition has stabilized and usually not longer than 48 to 72 hours.
Although adverse reactions associated with high dose, short term corticosteroid therapy are uncommon, peptic ulceration may occur. Cerebral Edema Dexamethasone sodium phosphate injection is generally administered initially in a dosage of 10 mg intravenously followed by four mg every six hours intramuscularly until the symptoms of cerebral edema subside. Response is usually noted within 12 to 24 hours and dosage may be reduced after two to four days and gradually discontinued over a period of five to seven days.
For palliative management of patients with recurrent or inoperable brain tumors, maintenance therapy with two mg two or t… [Excerpted — this section continues on DailyMed.]
⛔ Contraindications ▾
CONTRAINDICATIONS: Systemic fungal infections (see WARNINGS regarding amphotericin B). Hypersensitivity to any component of this product, including sulfites (see WARNINGS ).
⚠️ Warnings ▾
WARNINGS: 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. Anaphylactoid and hypersensitivity reactions have been reported for dexamethasone sodium phosphate (see ADVERSE REACTIONS ). In patients on corticosteroid therapy subjected 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: • Reduce resistance to new infections • Exacerbate existing infections • Increase the risk of disseminated infections • Increase the risk of reactivation or exacerbation of latent infections • Mask some signs of infection 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 nonimmune, particular care should be taken to avoid exposure to varicella and measles: • If a dexamethasone sodium phosphate injection-treated patient is exposed to varicella, prophylaxis with varicella zoster immune globulin may be indicated. If varicella develops, treatment with antiviral agents may be considered. • If a dexamethasone sodium phosphate injection-treated patient is exposed to measles, prophylaxis with immunoglobulin may be indicated.
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 t… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
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 Pathologic fracture of long bones Vertebral compression fractures Aseptic necrosis of femoral and humeral heads Tendon rupture Gastrointestinal: Peptic ulcer with possible subsequent perforation and hemorrhage Perforation of the small and large bowel, particularly in patients with inflammatory bowel disease Pancreatitis Abdominal distention Ulcerative esophagitis Dermatologic: Impaired wound healing Thin fragile skin Petechiae and ecchymoses Erythema Increased sweating May suppress reactions to skin tests Burning or tingling, especially in the perineal area (after IV injection) Other cutaneous reactions, such as allergic dermatitis, urticaria, angioneurotic edema Neurologic: Convulsions Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment Vertigo Headache Psychic disturbances 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 Hirsutism Ophthalmic: Posterior subcapsular cataracts Increased intraocular pressure Glaucoma Exophthalmos Metabolic: Negative nitrogen balance due to protein catabolism Cardiovascular: Myocardial rupture following recent myocardial infarction (see WARNINGS ) Other: Anaphylactoid or hypersensitivity reactions Thromboembolism Weight gain Increased appetite Nausea Malaise Hiccups The following additional adverse reactions are related to parenteral corticosteroid therapy: Rare instances of blindness associated with intralesional therapy around the face and head Hyperpigmentation or hypopigmentation Subcutaneous and cutaneous atrophy Sterile abscess Post-injection flare (following intra-articular use) Charcot-like arthropathy
🆘 Overdosage ▾
OVERDOSAGE: Reports of acute toxicity and/or death following overdosage of glucocorticoids are rare. In the event of overdosage, no specific antidote is available; treatment is supportive and symptomatic. The oral LD 50 of dexamethasone in female mice was 6.5 g/kg. The intravenous LD 50 of dexamethasone sodium phosphate in female mice was 794 mg/kg.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY: Dexamethasone sodium phosphate has a rapid onset but short duration of action when compared with less soluble preparations. Because of this, it is suitable for the treatment of acute disorders responsive to adrenocortical steroid therapy. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states.
Their synthetic analogs, including dexamethasone, 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.
At equipotent anti-inflammatory doses, dexamethasone almost completely lacks the sodium-retaining property of hydrocortisone and closely related derivatives of hydrocortisone.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Dexamethasone Sodium Phosphate Injection, USP phosphate, is supplied as follows: Product Code Unit of Sale Strength Each RF16501 NDC 63323-165-51 Unit of 25 4 mg per mL NDC 63323-165-11 1 mL fill, in a 2 mL Flip-Top Single Dose Vial This product is RFID-enabled. 16501 NDC 63323-165-01 Unit of 25 4 mg per mL NDC 63323-165-02 1 mL fill, in a 2 mL Flip-Top Single Dose Vial RF16505 NDC 63323-165-53 Unit of 25 20 mg per 5 mL (4 mg per mL) NDC 63323-165-13 5 mL fill, in a 5 mL Flip-Top Multiple Dose Vial This product is RFID-enabled.
16505 NDC 63323-165-05 Unit of 25 20 mg per 5 mL (4 mg per mL) NDC 63323-165-03 5 mL fill, in a 5 mL Flip-Top Multiple Dose Vial 16530 NDC 63323-165-30 Packaged Individually 120 mg per 30 mL (4 mg per mL) NDC 63323-165-30 30 mL fill, in a 30 mL Flip-Top Multiple Dose Vial STORE AT: 20 °C to 25 °C ( 68 °F to 77 °F) [see USP Controlled Room Temperature]. Protect from freezing. Sensitive to heat.
Do not autoclave. Protect from light. Store container in carton until contents have been used.
Do not use if precipitate is present. The container closure is not made with natural rubber latex.
📋 Description ▾
DESCRIPTION: Dexamethasone sodium phosphate is a water-soluble inorganic ester of dexamethasone. It occurs as a white or slightly yellow crystalline powder, is odorless or has a slight odor of alcohol, is exceedingly hygroscopic and is freely soluble in water. Dexamethasone sodium phosphate is an adrenocortical steroid anti-inflammatory drug.
Chemically, dexamethasone sodium phosphate is 9-Fluoro-11ß,17,21-trihydroxy-16α-methylpregna-1, 4-diene-3,20-dione 21-(dihydrogen phosphate) disodium salt and has the following structural formula: Dexamethasone Sodium Phosphate Injection, USP is a sterile solution of dexamethasone sodium phosphate in water for injection for intravenous (IV), intramuscular (IM), intra-articular, soft-tissue or intralesional use. Each mL contains dexamethasone sodium phosphate equivalent to dexamethasone phosphate 4 mg or dexamethasone 3.33 mg; benzyl alcohol 10 mg added as preservative; sodium citrate dihydrate 11 mg; sodium sulfite 1 mg as an antioxidant; Water for Injection q.s.
Citric acid and/or sodium hydroxide may have been added for pH adjustment (7.0 to 8.5). Air in the container is displaced by nitrogen. dexam-struc-01.jpg
⚠️ Precautions ▾
PRECAUTIONS: This product, like many other steroid formulations, is sensitive to heat. Therefore, it should not be autoclaved when it is desirable to sterilize the exterior of the vial. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including fever, myalgia, arthralgia, and malaise.
This may occur in patients even without evidence of adrenal insufficiency. 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. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving large doses of corticosteroids may be minimal or absent.
Fat embolism has been reported as a possible complication of hypercortisonism. When large doses are given, some authorities advise that antacids be administered between meals to help to prevent peptic ulcer. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully followed.
Steroids may increase or decrease motility and number of spermatozoa in some patients. Phenytoin, phenobarbital, ephedrine, and rifampin may enhance the metabolic clearance of corticosteroids resulting in decreased blood levels and lessened physiologic activity, thus requiring adjustment in corticosteroid dosage. These interactions may interfere with dexamethasone suppression tests which should be interpreted with caution during administration of these drugs.
False negative results in the dexamethasone suppression test (DST) in patients being treated with indomethacin have been reported. Thus, results of the DST should be interpreted with caution in these patients. The prothrombin time should be checked frequently in patients who are receiving corticosteroids and coumarin anticoagulants at the same time because of reports that corticosteroids have altered the response to these anticoagulants.
Studies have shown that the usual effect produced by adding corticosteroids is inhibition of response to coumarins, although there have been some conflicting reports of potentiation not substantiated by studies. When corticosteroids are administered concomitantly with potassium-depleting diuretics, patients should be observed closely for development of hypokalemia. 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 is suggestive of septic arthritis. If this complication occurs and the diagnosis of sepsis is confirmed, appropriate antimicrobial therapy should be instituted.
Injection of a steroid into an infected site is to be avoided. Corticosteroids should not be injected into unstable joints. Patients should be impressed strongly with the importance of not overusing joints in which symptomatic benefit has been obtained as long as th… [Excerpted — this section continues on DailyMed.]
📚 References ▾
REFERENCES: 1. Cavanagh, D.; Singh, K.B.: Endotoxin shock in pregnancy and abortion, in: “Corticosteroids in the Treatment of Shock”, Schumer, W.; Nyhus, L.M., Editors, Urbana, University of Illinois Press, 1970, pp. 86-96.
2. Dietzman, R.H.; Ersek, R.A.; Bloch, J.M.; Lillehei, R.C.: High-output, low-resistance gram-negative septic shock in man, Angiology 20 : 691-700, Dec. 1969.
3. Frank, E.: Clinical observations in shock and management (In: Shields, T.F., ed.: Symposium on current concepts and management of shock), J. Maine Med.
Ass. 59 : 195-200, Oct. 1968.
4. Oaks, W. W.; Cohen, H.E.: Endotoxin shock in the geriatric patient, Geriat.
22 : 120-130, Mar. 1967. 5.
Schumer, W.; Nyhus, L.M.: Corticosteroid effect on biochemical parameters of human oligemic shock, Arch. Surg. 100 : 405-408, Apr.
1970.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL - PRINCIPAL DISPLAY – Dexamethasone Sodium Phosphate 1 mL Vial Label NDC 63323-165-11 RF16501 Dexamethasone Sodium Phosphate Injection, USP 4 mg per mL For IM or IV use. See insert for other routes. Sterile. 1 mL Single Dose Vial Rx only dexam-label-01.jpg
PACKAGE LABEL - PRINCIPAL DISPLAY - Dexamethasone Sodium Phosphate 1 mL Tray Label NDC 63323-165-51 RF16501 Dexamethasone Sodium Phosphate Injection, USP 4 mg per mL* For intramuscular or intravenous use. See insert for other routes. 25 x 1 mL Single Dose Vials Rx only dexam-label-02.jpg
PACKAGE LABEL - PRINCIPAL DISPLAY – Dexamethasone Sodium Phosphate 1 mL Vial Label NDC 63323-165-02 16501 Dexamethasone Sodium Phosphate Injection, USP 4 mg per mL For IM or IV use. See insert for other routes. Sterile. 1 mL Single Dose Vial Rx only dexam-label-03.jpg
PACKAGE LABEL - PRINCIPAL DISPLAY – Dexamethasone Sodium Phosphate 1 mL Tray Label NDC 63323-165-01 16501 Dexamethasone Sodium Phosphate Injection, USP 4 mg per mL* For intramuscular or intravenous use. See insert for other routes. 25 x 1 mL Single Dose Vials Rx only dexam-label-04.jpg
PACKAGE LABEL - PRINCIPAL DISPLAY – Dexamethasone Sodium Phosphate 5 mL Vial Label NDC 63323-165-13 RF16505 Dexamethasone Sodium Phosphate Injection, USP 20 mg per 5 mL (4 mg per mL) For IM or IV use. See insert for other routes. 5 mL Multiple Dose Vial Rx only dexam-label-05.jpg
PACKAGE LABEL - PRINCIPAL DISPLAY – Dexamethasone Sodium Phosphate 5 mL Tray Label NDC 63323-165-53 RF16505 Dexamethasone Sodium Phosphate Injection, USP. 20 mg per 5 mL (4 mg per mL*) For intramuscular or intravenous use. See insert for other routes. 25 x 5 mL Multiple Dose Vials Rx only dexam-label-06.jpg
PACKAGE LABEL - PRINCIPAL DISPLAY – Dexamethasone Sodium Phosphate 5 mL Vial Label NDC 63323-165-03 16505 Dexamethasone Sodium Phosphate Injection, USP 20 mg per 5 mL (4 mg per mL) For IM or IV use. See insert for other routes. 5 mL Multiple Dose Vial Rx only dexam-label-07.jpg
PACKAGE LABEL - PRINCIPAL DISPLAY – Dexamethasone Sodium Phosphate 5 mL Tray Label NDC 63323-165-05 16505 Dexamethasone Sodium Phosphate Injection, USP 20 mg per 5 mL (4 mg per mL*) For intramuscular or intravenous use. See insert for other routes. 25 x 5 mL Multiple Dose Vials Rx only dexam-label-08.jpg
PACKAGE LABEL - PRINCIPAL DISPLAY – Dexamethasone Sodium Phosphate 30 mL Vial Label NDC 63323-165-30 16530 Dexamethasone Sodium Phosphate Injection, USP 120 mg per 30 mL (4 mg per mL*) For intramuscular or intravenous use. See insert for other routes. 30 mL Multiple Dose Vial Rx only dexam-label-09.jpg
PACKAGE LABEL - PRINCIPAL DISPLAY – Dexamethasone Sodium Phosphate 30 mL Individual Carton Label NDC 63323-165-30 Dexamethasone Sodium Phosphate Injection, USP 120 mg per 30 mL (4 mg per mL*) For intramuscular or intravenous use. See insert for other routes. Rx only 30 mL Multiple Dose Vial dexam-label-10.jpg
Medicaid utilization by pack size
Medicare Part D spend CMS · PART D · 2026 (Q1)
About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |