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Dexamethasone Sodium Phosphate 4 mg/mL Injection — NDC 87063-0289-25 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dexamethasone Sodium Phosphate 4 mg/mL Injection — NDC 87063-289-25 (Billing 87063-0289-25)

by ASCLEMED USA INC. · 25 VIAL in 1 CARTON / 5 mL in 1 VIAL

This is a package of Dexamethasone Sodium Phosphate 4 mg/mL Injection from ASCLEMED USA INC., marketed since Jul 1975 and currently FDA-listed.

NDC 87063-0289-25
🏷️ FDA NDC (as labeled) 87063-289-25 billing pads the product segment with a zero
This package
Contains5 mL in 1 vial Pack sizes2 compare ↓
Product page 87063-0289-10 Also comes in: 10 vials 87063-289-10
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Dexamethasone Sodium Phosphate (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Feb 4, 2026 — Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate. (SOMERSET THERAPEUTICS LLC) · FDA recall D-0398-2026
Class II · May 23, 2024 — Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec. (Eugia US LLC) · FDA recall D-0555-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 87063-289-25
Product NDC 87063-289
11-digit billing NDC 87063028925
RxCUI 1116927
UNII AI9376Y64P
Application # ANDA084282
SPL Set ID a31b013f-924c-42f8-b8ab-ce60bb8ad7b8
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1975-07-15
Route INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE
Dosage form INJECTION
Substance DEXAMETHASONE SODIUM PHOSPHATE
TE code (Orange Book) AP · RLD · RS
Quick answers
  • RxCUI (RxNorm): 1116927
Why two NDCs? The FDA registers this code as 87063-289-25 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 87063-0289-25. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids for local oral treatment, Corticosteroids, Corticosteroids, moderately potent (group II)
How it works Corticosteroid Hormone Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

Dexamethasone injection is used to treat severe allergic reactions. It is used in the management of certain types of edema (fluid retention and swelling; excess fluid held in body tissues,) gastrointestinal disease, and certain types of arthritis. Dexamethasone injection is also used for diagnostic testing. Dexamethasone injection is also used to treat certain conditions that affect the blood, skin, eyes, thyroid, kidneys, lungs, and nervous system. It is sometimes used in combination with other medications to treat symptoms of low corticosteroid levels (lack of certain substances that are usu...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • 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...
📖 Read our full Dexamethasone guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
8
Nutrient depletion considerations

Dexamethasone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Dexamethasone nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer eachPer 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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 10 vials
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
87063-0289-10 87063-289-10 Main listing 10 VIAL in 1 CARTON / 5 mL in 1 VIAL 2026-08-07 — Active
87063-0289-25 You're viewing this 25 VIAL in 1 CARTON / 5 mL in 1 VIAL 2026-08-07 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 25 vial in 1 carton / 5 ml in 1 vial.
What NDC number is used to bill for this package of Dexamethasone Sodium Phosphate 4 mg/mL Injection?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dexamethasone Sodium Phosphate 4 mg/mL 67457-0418-05 Mylan 25 vials $0.238 AP Availability likely —
Dexamethasone Sodium Phosphate 4 mg/mL 67457-0422-54 Mylan 25 vials $0.238 AP Availability likely —
Dexamethasone Sodium Phosphate 4 mg/mL 67457-0419-01 Mylan 25 vials $0.674 AP Discontinued —
Dexamethasone Sodium Phosphate 4 mg/mL 00641-6145-25 Hikma 25 vials $0.674 AP Availability likely —
Dexamethasone Sodium Phosphate 4 mg/mL 72572-0120-25 Civica, 25 vials $0.674 AP Availability likely —
Dexamethasone Sodium Phosphate 4 mg/mL 67457-0423-12 Mylan 25 vials $0.674 AP Availability likely —
Dexamethasone Sodium Phosphate 4 mg/mL 25021-0052-01 Sagent 25 vials $0.674 AP Availability likely —
Dexamethasone Sodium Phosphate 4 mg/mL 76420-0077-01 Asclemed 1 ml — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 76420-0185-01 Asclemed 1 ml — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 71872-7021-01 Medical 1 vial — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 71872-7092-01 Medical 1 vial — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 71872-7128-01 Medical 1 vial — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 71872-7147-01 Medical 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 71872-7153-01 Medical 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 71872-7157-01 Medical 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 71872-7164-01 Medical 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 71872-7171-01 Medical 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 76420-0555-01 Asclemed 1 ml — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 84549-0422-54 ProPharma 5 ml — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 70121-1451-05 Amneal 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 76045-0106-10 Fresenius 1 syringe — AP Discontinued —
Dexamethasone Sodium Phosphate 4 mg/mL 51662-1660-03 HF 10 pouches — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 55150-0238-05 Eugia 25 vials — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 68083-0474-25 Gland 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 76420-0398-30 Asclemed 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 55150-0239-30 Eugia 25 vials — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 67457-0421-30 Mylan 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 76420-0396-01 Asclemed 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 76420-0397-05 Asclemed 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 50090-3300-00 A-S 25 vials — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 67457-0484-30 Mylan 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 70069-0023-25 Somerset 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 71872-7347-01 Medical 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 50090-1922-00 A-S 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 51662-1432-01 HF 30 ml — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 55150-0237-01 Eugia 25 vials — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 68083-0473-25 Gland 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 70518-3724-00 REMEDYREPACK 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 70069-0024-25 Somerset 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 76045-0210-10 Fresenius 1 syringe — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 00641-6146-25 Hikma 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 84549-0421-30 ProPharma 30 ml — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 70069-0022-25 Somerset 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 70121-1450-05 Amneal 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 50090-2313-02 A-S 2 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 51662-1297-01 HF 5 ml — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 70121-1452-01 Amneal 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 00404-9795-30 Henry 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 00404-9805-05 Henry 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 70518-4372-00 REMEDYREPACK 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 85766-0215-25 Sportpharm 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 85766-0217-25 Sportpharm 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 85766-0216-25 Sportpharm 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mLthis 87063-0289-25 ASCLEMED 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 87063-0290-25 ASCLEMED 25 vials — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1975
On the market since
Jul 1975
📍
2026
Currently FDA-listed
51 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerASCLEMED USA INC.
Application holderHIKMA PHARMACEUTICALS USA INC
FDA applicationANDA084282 (ANDA)
Labeler code87063
First marketedJul 1975
Product typeHuman Prescription Drug
Portfolio129 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

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 (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 ede… [Excerpted — this section continues on DailyMed.]

⏱️ Dosage and Administration ~3 min read ▾

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 latter 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 instrasynovial 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… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 4 words ▾

CONTRAINDICATIONS Systemic fungal infections.

⚠️ Warnings ~2 min read ▾

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, 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 withdrawal or dosage reduction as needed.

Tuberculosis If Dexamethasone Sodium Phosphate 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. 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: If a Dexamethasone Sodium Phosphate -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 -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. 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. 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, may exacerbate systemic fungal infections; therefore, avoid Dexamethasone Sodium Phosphate use in the presence of such infections unless Dexamethasone Sodium Phosphate is needed to control drug reactions.

For patients on chronic Dexamethasone Sodium Phosphate therapy who develop systemic fungal infections, Dexamethasone Sodium Phosphate withdrawal or dosage reduction is recommended. Amebiasis Corticosteroids, including Dexamethasone Sodium Phosphate, may activate latent amebiasis. Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating Dexamethasone Sodium Phosphate in patients who have spent… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 180 words ▾

ADVERSE REACTIONS 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 Postinjection flare following intra-articular use Charcot-like arthropathy Itching, burning, tingling in the ano-genital region

🤰 Pregnancy ~2 min read ▾

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. Dexamethasone Sodium Phosphate Injection 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.

🧬 Clinical Pharmacology 54 words ▾

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.

📦 How Supplied / Storage and Handling 126 words ▾

HOW SUPPLIED Dexamethasone Sodium Phosphate Injection, USP is available in the following package: 4 mg/mL 1 mL vials packaged in 25s NDC 87063-290-25 (NDC 0641-6145-25) 5 mL vials packaged in 10s NDC 87063-289-10 (NDC 0641-6146-10) 5 mL vials packaged in 25s NDC 87063-289-25 (NDC 0641-6146-25) Storage Protect from light: Keep covered in carton until time of use. Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Avoid freezing.

Do not use if solution is hazy or has a precipitate. Do not autoclave. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For Product Inquiry call 1-877-845-0689. Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501

📦 Storage and Handling 81 words ▾

Storage Protect from light: Keep covered in carton until time of use. Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Avoid freezing.

Do not use if solution is hazy or has a precipitate. Do not autoclave. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For Product Inquiry call 1-877-845-0689. Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501

📋 Description 183 words ▾

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, a synthetic adrenocortical steroid, is a white or slightly yellow crystalline powder. It is freely soluble in water and is exceedingly hygroscopic.

The molecular weight is 516.41. It is designated chemically as 9-fluoro-11β,17-dihydroxy-16α-methyl-21-(phosphonooxy)pregna-1,4-diene-3, 20-dione disodium salt. The molecular formula is: C 22 H 28 FNa 2 O 8 P and the structural formula is: Dexamethasone Sodium Phosphate Injection is a sterile solution of dexamethasone sodium phosphate for intravenous and intramuscular use.

The 4 mg/mL strength may also be used for intra-articular, intralesional and soft tissue administration. Each mL of Dexamethasone Sodium Phosphate Injection 4 mg/mL contains dexamethasone sodium phosphate, equivalent to 4 mg dexamethasone phosphate or 3.33 mg dexamethasone. Inactive ingredients per mL: 1 mg sodium sulfite anhydrous, 19.4 mg sodium citrate anhydrous and 10.42 mg (0.01 mL) benzyl alcohol (preservative) in Water for Injection.

The pH of both concentrations is 7.0-8.5; sodium hydroxide and/or citric acid used, if needed, for pH adjustment. Sealed under nitrogen. Structural formula

⚠️ Precautions ~2 min read ▾

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.

📄 Package Label / Principal Display Panel 16 words ▾

PRINCIPAL DISPLAY PANEL-4 mg/mL (1 mL Vial) 1

PRINCIPAL DISPLAY PANEL-4 mg/mL (5 mL Vial) 5

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Dexamethasone Sodium Phosphate — the program that covers self-administered drugs. 11 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Dexamethasone Sodium Phosphate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$780.5K
Claims incl. refills
22.5K
Beneficiaries
17.3K
Spend / beneficiary
$45.01
Spend / claim
$34.65
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by ASCLEMED USA INC.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 10 vials (87063-0289-10). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
ASCLEMED USA INC. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 87063-0288-09 · ASCLEMED 87063-0290-25 · ASCLEMED →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.