Dexamethasone Sodium Phosphate 10 mg/mL Injection, Solution, 25 vials
Other active recalls for Dexamethasone Sodium Phosphate (different manufacturers) — 2 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
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 ↗- You're right that it treats a lot of conditions, and that can feel confusing. Dexamethasone is a corticosteroid, which is a type of anti-inflammatory medicine. Whether it's calming...
- Why has my doctor prescribed dexamethasone — it seems to be used for so many different things?
- Please don't stop it abruptly without talking to your doctor first, especially if you've been on it for more than a few days. Your body adjusts to having this medication on board,...
- Can I just stop taking dexamethasone if I feel better or if I'm worried about side effects?
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?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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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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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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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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.
4 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.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 | $1.293 | $32.32 / 25 ml |
| Medicaid paysCMS SDUD · 12 mo | $119.08 | $2,977.11 / 25 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J1100 | $0.085 / J1100 unit | — |
Where does this data come from?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dexamethasone Sodium Phosphate 10 mg/mL 70069-0025-10 | Somerset | 10 vials | $0.504 | AP | Availability likely | save 61% |
| Dexamethasone Sodium Phosphate 10 mg/mL 63323-0516-10 | Fresenius | 10 vials | $0.504 | AP | Availability likely | save 61% |
| Dexamethasone Sodium Phosphate 10 mg/mL 67457-0420-10 | Mylan | 10 vials | $0.504 | AP | Availability likely | save 61% |
| Dexamethasone Sodium Phosphate 10 mg/mL 67457-0483-10 | Mylan | 10 vials | $0.504 | AP | Availability likely | save 61% |
| Dexamethasone Sodium Phosphate 10 mg/mL 00641-0367-25 | Hikma | 25 vials | $1.236 | AP | Availability likely | save 4% |
| Dexamethasone Sodium Phosphate 10 mg/mL 72572-0122-25 | Civica, | 25 vials | $1.236 | AP | Availability likely | save 4% |
| Dexamethasone Sodium Phosphate 10 mg/mL 25021-0053-01 | Sagent | 25 vials | $1.293 | AP | Availability likely | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 55150-0304-25 | Eugia | 25 vials | $1.293 | AP | Availability likely | — |
| Dexamethasone Sodium Phosphate 10 mg/mLthis 63323-0506-16 | Fresenius | 25 vials | $1.293 | AP | Availability likely | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 70069-0021-25 | Somerset | 25 vials | $1.293 | AP | Availability likely | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 72485-0118-25 | Armas | 25 vials | $1.293 | AP | Availability likely | — |
| Dexamethasone sodium phosphate 10 mg/mL 42571-0432-79 | Micro | 25 vials | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 50090-3541-00 | A-S | 25 vials | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 68083-0607-25 | Gland | 25 vials | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 70121-1399-05 | Amneal | 25 vials | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 71872-7091-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 80425-0261-01 | Advanced | 25 vials | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 85766-0071-01 | Sportpharm | 1 ml | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 85766-0186-25 | Sportpharm | 25 vials | — | AP | FDA listed | — |
| Dmt Suik 10 mg/mL 76420-0270-01 | Asclemed | 1 vial | — | — | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 51662-1343-01 | HF | 1 ml | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 71872-7090-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 71872-7205-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 76045-0212-10 | Fresenius | 1 syringe | — | AP | FDA listed | — |
| Dmt Suik 10 mg/mL 80425-0556-01 | Advanced | 1 vial | — | — | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 51662-1391-01 | HF | 10 ml | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 55154-5118-05 | Cardinal | 5 vials | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 70518-0532-01 | REMEDYREPACK | 25 vials | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 76420-0399-10 | Asclemed | 10 vials | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 00404-9842-10 | Henry | 1 vial | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 76045-0109-10 | Fresenius | 1 syringe | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 85766-0214-10 | Sportpharm | 10 vials | — | AP | FDA listed | — |
Where does this data come from?
⏳ 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?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 63323-0506-16 You're viewing this | 25 VIAL in 1 TRAY (63323-506-16) / 1 mL in 1 VIAL (63323-506-41) | $1.29 / mL | $32.32 | 2003-05-29 | Active |
| 63323-0506-01 | 25 VIAL in 1 TRAY (63323-506-01) / 1 mL in 1 VIAL | $1.29 / mL | $32.32 | 2003-05-29 | Active |
| 63323-0506-13 | 25 VIAL in 1 TRAY (63323-506-13) / 1 mL in 1 VIAL (63323-506-03) | — | — | 2025-01-06 | Active |
This pack has the lowest per-mL cost of the 2 priced pack sizes ($1.29 NADAC).
This pack accounts for about 9.8% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in NDC 63323-0506-16?
What is the difference between NDC 63323-0506-16 and NDC 63323-0506-01?
What NDC number is used to bill for this package of Dexamethasone Sodium Phosphate 10 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.
📄 Full prescribing information FDA SPL
⏱️ Dosage and Administration ▾
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 cur…
⛔ Contraindications ▾
CONTRAINDICATIONS Systemic fungal infections.
⚠️ Warnings ▾
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. 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.
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. Do not administer dexamethasone sodium phosphate injection by an intraarticular, intrabursal, intratendinous, or intralesional route in the presence of acute local infection.
Tuberculosis If dexamethasone sodium phosphate injection is used to treat a condition in patients with latent tuberculosis or tuberculin reactivity, reactivation of the disease may occur. Closely monitor such patients for reactivation. During prolonged dexamethasone sodium phosphate injection therapy, patients with latent tuberculosis or tuberculin reactivity should receive chemoprophylaxis.
Varicella Zoster and Measles Viral Infections Varicella and measles can have a serious or even fatal course in non-immune patients taking corticosteroids, including dexamethasone sodium phosphate injection. In corticosteroid-treated patients who have not had these diseases or are non-immune, particular care should be taken to avoid exposure to varicella and measles: • If a dexamethasone sodium phosphate injection-treated patient is exposed to varicella, prophylaxis with varicella zoster immune globulin (VZIG) 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 (IG) 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 p…
🤒 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 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
🤰 Pregnancy ▾
Usage in Pregnancy Since adequate human reproduction studies have not been done with corticosteroids, use of these drugs in pregnancy, nursing mothers or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. Average and large doses of cortisone or hydrocortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.
These effects are less likely to occur with the synthetic derivatives except when used in large doses. Patients with a stressed myocardium should be observed carefully and the drug administered slowly since premature ventricular contractions may occur with rapid administration. Dietary salt restriction and potassium supplementation may be necessary.
All corticosteroids increase calcium excretion. While on corticosteroid therapy patients should not be vaccinated against smallpox. Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially in high doses, because of possible hazards of neurological complications and lack of antibody response.
Because rare instances of anaphylactoid reactions have occurred in patients receiving parenteral corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Dexamethasone Sodium Phosphate Injection, USP (Preservative Free) equivalent to 10 mg dexamethasone phosphate, is supplied as follows: Product Code Unit of Sale Strength Each PRX500601 NDC 63323-506-16 Unit of 25 10 mg per mL NDC 63323-506-41 1 mL Single Dose Vial The container closure is not made with natural rubber latex. Storage Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. 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.
📦 Storage and Handling ▾
Storage Store at 20°C to 25°C (68°F 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.
📋 Description ▾
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, (11 ß , 16 α ). 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: 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. dexam-struc-01.jpg