Prescription drug · ANDA
Melphalan Hydrochloride NDC 67457-195
Kit · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67457-195-01 | 67457019501 | 1 KIT in 1 CARTON (67457-195-01) * 10 mL in 1 VIAL, GLASS (67457-193-50) * 10 mL in 1 VIAL, GLASS (67457-194-10)Marketed from Jan 10, 2013 |
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
- Mylan Institutional LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090270
- Marketing start
- Listing expires
- Identifiers
- Product ID 67457-195_14d237c9-0b9f-4101-ae53-c6ffe9928801SPL ID 14d237c9-0b9f-4101-ae53-c6ffe9928801SPL set ID a8bf1877-fd06-4ef6-b82d-fe0ff1956bdeRxCUI 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
N467457019501followed by a unit qualifier and the quantityPackage 67457-0195-01. 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 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.