Prescription drug · ANDA
Melphalan hydrochloride NDC 68083-259
Kit · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-259-01 | 68083025901 | 1 KIT in 1 CARTON (68083-259-01) * 10 mL in 1 VIAL, SINGLE-USE (68083-261-01) * 10 mL in 1 VIAL, SINGLE-DOSE (68083-260-01)Marketed from Jun 10, 2019 |
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
- Labeler
- Gland Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209826
- Marketing start
- Listing expires
- Identifiers
- Product ID 68083-259_c1a5c2ee-7acc-44f6-8e95-534a2d88e223SPL ID c1a5c2ee-7acc-44f6-8e95-534a2d88e223SPL set ID ea7fbf4e-4980-4bb4-bac9-99eb6f633ba0RxCUI 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.
- NDC on a medical claim
N468083025901followed by a unit qualifier and the quantityPackage 68083-0259-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS & 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 | — | KitIntravenous | Sagent Pharmaceuticals | 25021-258 |