Melphalan hydrochloride NDC 54288-109

NDC codes

FDA NDC Directory

Product NDC (as listed)54288-109Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54288-0109Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
54288-109-02	54288010902	1 KIT in 1 CARTON (54288-109-02) * 10 mL in 1 VIAL, SINGLE-DOSE (54288-106-01) * 10 mL in 1 VIAL, SINGLE-USE (54288-107-01)Marketed from Jul 2, 2021

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: BPI Labs LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209197
Marketing start: Jul 2, 2021
Listing expires: Dec 31, 2026
Identifiers: Product ID 54288-109_731e5310-a610-419d-bae0-89d4d2702731SPL ID 731e5310-a610-419d-bae0-89d4d2702731SPL set ID dab93975-0587-4f12-848c-9130bb02d036RxCUI 311487UPC 0354288109024

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

N454288010902 followed by a unit qualifier and the quantity

Package 54288-0109-02. 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 Dec 5, 2025.

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.

Full label on DailyMed (opens in a new tab)