Prescription drug · ANDA
Melphalan Hydrochloride NDC 67184-0618
Kit · Intravenous · Qilu Pharmaceutical Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67184-0618-2 | 67184061802 | 1 KIT in 1 CARTON (67184-0618-2) * 15 mL in 1 VIAL, SINGLE-DOSE (67184-0616-1) * 10 mL in 1 VIAL, SINGLE-USE (67184-0617-1)Marketed from Dec 18, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211463
- Marketing start
- Listing expires
- Identifiers
- Product ID 67184-0618_442e0308-4efa-428d-9250-177b95fd4feeSPL ID 442e0308-4efa-428d-9250-177b95fd4feeSPL set ID 91948ff9-6070-485b-b4b7-3cb477c1b24cRxCUI 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
N467184061802followed by a unit qualifier and the quantityPackage 67184-0618-02. 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 211463
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 | — | KitIntravenous | Avenacy Inc. | 83634-202 |
| Melphalan Hydrochloride | — | KitIntravenous | Arthur Group LLC | 84679-001 |