Prescription drug · ANDA
Melphalan hydrochloride NDC 72266-128
Kit · Fosun Pharma USA Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72266-128-01 | 7226601280172266012801 | 1 KIT in 1 CARTON (72266-128-01) * 10 mL in 1 VIAL, SINGLE-DOSE (72266-144-01) * 10 mL in 1 VIAL, SINGLE-USE (72266-145-01)Marketed from Sep 23, 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
- Fosun Pharma USA IncNDC labeler code 72266
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209826
- Marketing start
- Listing expires
- Identifiers
- Product ID 72266-128_2b363439-ace2-30e1-e063-6294a90ad47fSPL ID 2b363439-ace2-30e1-e063-6294a90ad47fSPL set ID 54712714-744d-4deb-83b2-694da49a9272RxCUI 311487UPC 0372266128010
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
N472266012801followed by a unit qualifier and the quantityPackage 72266-0128-01. 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.
About NDC 72266-128
- What is NDC 72266-128?
- 72266-128 is the product NDC for Melphalan hydrochloride kit, listed with the FDA by Fosun Pharma USA Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Melphalan hydrochloride.
- Who is the labeler?
- Fosun Pharma USA Inc, NDC labeler code 72266. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Melphalan hydrochloride?
- 12 other product NDCs are listed under this name. See all Melphalan hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Melphalan hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Melphalan hydrochloride | — | Kit | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-355 | 23155-0355-41 |
| Melphalan Hydrochloride | — | KitIntravenous | Arthur Group LLC | 84679-001 | 84679-0001-01 |
| Melphalan Hydrochloride | — | KitIntravenous | Dr.Reddy's Laboratories Inc | 75907-112 | 75907-0112-11 |
| Melphalan Hydrochloride | — | Kit | Camber Pharmaceuticals, Inc. | 31722-362 | 31722-0362-31 |
| Melphalan Hydrochloride | — | KitIntravenous | Sagent Pharmaceuticals | 25021-258 | 25021-0258-61 |
| Melphalan Hydrochloride | — | KitIntravenous | Qilu Pharmaceutical Co., Ltd. | 67184-0618 | 67184-0618-02 |
| Melphalan Hydrochloride | — | KitIntravenous | Avenacy Inc. | 83634-202 | 83634-0202-61 |
| Melphalan hydrochloride | — | Kit | BPI Labs LLC | 54288-109 | 54288-0109-02 |
| Melphalan hydrochloride | — | KitIntravenous | Meitheal Pharmaceuticals Inc. | 71288-132 | 71288-0132-90 |
| Melphalan hydrochloride | — | Kit | Gland Pharma Limited | 68083-259 | 68083-0259-01 |
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 | — | KitIntravenous | Sagent Pharmaceuticals | 25021-258 |
| Melphalan hydrochloride | — | Kit | Gland Pharma Limited | 68083-259 |