Prescription drug · ANDA
Dexamethasone Sodium Phosphate NDC 76420-397
Dexamethasone sodium phosphate 4 mg/mL · Injection, Solution · Intra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-397-05 | 7642003970576420039705 | 25 VIAL in 1 CARTON (76420-397-05) / 5 mL in 1 VIAL (76420-397-00)Marketed from May 31, 2025 |
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
- Asclemed USA, Inc.NDC labeler code 76420
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040803
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 76420-397_36e3b30e-3943-244e-e063-6394a90aba7dSPL ID 36e3b30e-3943-244e-e063-6394a90aba7dSPL set ID 36854dbc-22f2-5df9-e063-6394a90ad934RxCUI 309696, 1116927, 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
N476420039705followed by a unit qualifier and the quantityPackage 76420-0397-05. 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. By intravenous or intramuscular injection when oral therapy is not feasible 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 adrenoco…
Excerpt only. Read the full label for complete information.
About NDC 76420-397
- What is NDC 76420-397?
- 76420-397 is the product NDC for Dexamethasone Sodium Phosphate, Dexamethasone sodium phosphate 4 mg/mL injection, solution, listed with the FDA by Asclemed USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dexamethasone Sodium Phosphate.
- What is the active ingredient?
- Dexamethasone sodium phosphate.
- Who is the labeler?
- Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dexamethasone Sodium Phosphate?
- 94 other product NDCs are listed under this name. See all Dexamethasone Sodium Phosphate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dexamethasone Sodium Phosphate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | REMEDYREPACK INC. | 70518-4372 | 70518-4372-00 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 10 mg/mL | Injection, SolutionIntramuscular, Intravenous | Armas Pharmaceuticals | 72485-118 | 72485-0118-25 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Henry Schein, Inc. | 0404-9795 | 00404-9795-30 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | InjectionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Henry Schein, Inc. | 0404-9805 | 00404-9805-05 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Medical Purchasing Solutions, LLC. | 71872-7347 | 71872-7347-01 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Sagent Pharmaceuticals | 25021-052 | 25021-0052-0125021-0052-05 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 10 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Sagent Pharmaceuticals | 25021-053 | 25021-0053-01 |
| Dexamethasone sodium phosphate | Dexamethasone sodium phosphate 10 mg/mL | Injection, SolutionIntramuscular, Intravenous | Micro Labs Limited | 42571-432 | 42571-0432-4042571-0432-79 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 10 mg/mL | Injection, EmulsionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 76045-212 | 76045-0212-10 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 10 mg/mL | InjectionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Gland Pharma Limited | 68083-607 | 68083-0607-25 |
Other NDCs under ANDA 040803
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 | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | ProPharma Distribution | 84549-421 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | ProPharma Distribution | 84549-422 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Henry Schein, Inc. | 0404-9795 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | A-S Medication Solutions | 50090-1922 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Asclemed USA, Inc. | 76420-185 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Asclemed USA, Inc. | 76420-398 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Asclemed USA, Inc. | 76420-396 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Sportpharm LLC | 85766-216 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Sportpharm LLC | 85766-215 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Sportpharm LLC | 85766-217 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Medical Purchasing Solutions, LLC | 71872-7147 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Medical Purchasing Solutions, LLC | 71872-7157 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Medical Purchasing Solutions, LLC | 71872-7153 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | A-S Medication Solutions | 50090-2313 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Mylan Institutional LLC | 67457-421 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Mylan Institutional LLC | 67457-422 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Mylan Institutional LLC | 67457-423 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Mylan Institutional LLC | 67457-484 |