Prescription drug · ANDA
Dexamethasone Sodium Phosphate NDC 25021-052
Dexamethasone sodium phosphate 4 mg/mL · Injection, Solution · Intra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-052-01 | 25021005201 | 25 VIAL in 1 CARTON (25021-052-01) / 1 mL in 1 VIALMarketed from Dec 1, 2024 | |
| 25021-052-05 | 25021005205 | 25 VIAL in 1 CARTON (25021-052-05) / 5 mL in 1 VIALMarketed from Dec 1, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Dexamethasone Sodium Phosphate
- Generic name (nonproprietary)
- dexamethasone sodium phosphate
- Active ingredients
- Dexamethasone sodium phosphate — 4 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue
- Labeler
- Sagent Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215654
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 25021-052_d68d6aab-10d8-4333-9fe8-a0386f8caa07SPL ID d68d6aab-10d8-4333-9fe8-a0386f8caa07SPL set ID 4680d517-ed5a-4137-819c-122ee962a464RxCUI 1116927, 1812079, 1812194UNII AI9376Y64P
- Pharmacologic class
- Corticosteroid
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N425021005201followed by a unit qualifier and the quantityPackage 25021-0052-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215654
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | InjectionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Gland Pharma Limited | 68083-473 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | InjectionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Gland Pharma Limited | 68083-474 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 10 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Sagent Pharmaceuticals | 25021-053 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | REMEDYREPACK INC. | 70518-4372 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Medical Purchasing Solutions, LLC. | 71872-7347 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 10 mg/mL | InjectionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Gland Pharma Limited | 68083-607 |