What is NDC 54288-109?

54288-109 is the product NDC for Melphalan hydrochloride kit, listed with the FDA by BPI Labs LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

BPI Labs LLC, NDC labeler code 54288. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

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	5428801090254288010902	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 LLCNDC labeler code 54288
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)

About NDC 54288-109

What is NDC 54288-109?: 54288-109 is the product NDC for Melphalan hydrochloride kit, listed with the FDA by BPI Labs LLC. 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?: BPI Labs LLC, NDC labeler code 54288. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Melphalan hydrochloride NDCs
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	—	KitIntravenous	Meitheal Pharmaceuticals Inc.	71288-132	71288-0132-90
Melphalan hydrochloride	—	Kit	Fosun Pharma USA Inc	72266-128	72266-0128-01
Melphalan hydrochloride	—	Kit	Gland Pharma Limited	68083-259	68083-0259-01

All 13 Melphalan hydrochloride NDCs