Prescription drug · ANDA
Melphalan Hydrochloride NDC 25021-258
Kit · Intravenous · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-258-61 | 25021025861 | 1 KIT in 1 CARTON (25021-258-61) * 10 mL in 1 VIAL (25021-256-10) * 10 mL in 1 VIAL (25021-257-10)Marketed from Apr 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)
- Melphalan Hydrochloride
- Generic name (nonproprietary)
- melphalan hydrochloride
- Dosage form
- Kit
- Route
- Intravenous
- Labeler
- Sagent Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209826
- Marketing start
- Listing expires
- Identifiers
- Product ID 25021-258_6c52e5c7-4b97-451c-aacd-b43046fd164aSPL ID 6c52e5c7-4b97-451c-aacd-b43046fd164aSPL set ID 35f3d9fe-3c2f-4362-9d40-cdab014cac38RxCUI 311487
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
N425021025861followed by a unit qualifier and the quantityPackage 25021-0258-61. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Melphalan Hydrochloride for Injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209826
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 |
|---|---|---|---|---|
| Melphalan hydrochloride | — | Kit | Fosun Pharma USA Inc | 72266-128 |
| Melphalan hydrochloride | — | Kit | Gland Pharma Limited | 68083-259 |