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NDC 00641-0367-25 Dexamethasone Sodium Phosphate 10 mg/mL Details
Dexamethasone Sodium Phosphate 10 mg/mL
Dexamethasone Sodium Phosphate is a INTRAMUSCULAR; INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is DEXAMETHASONE SODIUM PHOSPHATE.
MedlinePlus Drug Summary
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 usually produced by the body and are needed for normal body functioning) and in the management of certain types of shock. Dexamethasone injection is in a class of medications called corticosteroids. It works to treat people with low levels of corticosteroids by replacing steroids that are normally produced naturally by the body. It also works to treat other conditions by reducing swelling and redness and by changing the way the immune system works.
Related Packages: 00641-0367-25Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dexamethasone Injection
Product Information
| NDC | 00641-0367 |
|---|---|
| Product ID | 0641-0367_170a32e9-fea2-4e2b-95f2-bdd9b78cb615 |
| Associated GPIs | 22100020202010 |
| GCN Sequence Number | 006776 |
| GCN Sequence Number Description | dexamethasone sodium phosphate VIAL 10 MG/ML INJECTION |
| HIC3 | P5A |
| HIC3 Description | GLUCOCORTICOIDS |
| GCN | 27350 |
| HICL Sequence Number | 002888 |
| HICL Sequence Number Description | DEXAMETHASONE SODIUM PHOSPHATE |
| Brand/Generic | Generic |
| Proprietary Name | Dexamethasone Sodium Phosphate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dexamethasone Sodium Phosphate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAMUSCULAR; INTRAVENOUS |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/mL |
| Substance Name | DEXAMETHASONE SODIUM PHOSPHATE |
| Labeler Name | Hikma Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA087702 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00641-0367-25 (00641036725)
| NDC Package Code | 0641-0367-25 |
|---|---|
| Billing NDC | 00641036725 |
| Package | 25 VIAL in 1 CARTON (0641-0367-25) / 1 mL in 1 VIAL (0641-0367-21) |
| Marketing Start Date | 1982-09-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |