What is NDC 68083-259?

68083-259 is the product NDC for Melphalan hydrochloride kit, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Gland Pharma Limited, NDC labeler code 68083. 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 68083-259

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-259Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0259Add 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
68083-259-01	6808302590168083025901	1 KIT in 1 CARTON (68083-259-01) * 10 mL in 1 VIAL, SINGLE-USE (68083-261-01) * 10 mL in 1 VIAL, SINGLE-DOSE (68083-260-01)Marketed from Jun 10, 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: Gland Pharma LimitedNDC labeler code 68083
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209826
Marketing start: Jun 10, 2019
Listing expires: Dec 31, 2027
Identifiers: Product ID 68083-259_c1a5c2ee-7acc-44f6-8e95-534a2d88e223SPL ID c1a5c2ee-7acc-44f6-8e95-534a2d88e223SPL set ID ea7fbf4e-4980-4bb4-bac9-99eb6f633ba0RxCUI 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

N468083025901 followed by a unit qualifier and the quantity

Package 68083-0259-01. 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 Jun 7, 2019. 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.

Full label on DailyMed (opens in a new tab)

About NDC 68083-259

What is NDC 68083-259?: 68083-259 is the product NDC for Melphalan hydrochloride kit, listed with the FDA by Gland Pharma Limited. 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?: Gland Pharma Limited, NDC labeler code 68083. 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	—	Kit	BPI Labs LLC	54288-109	54288-0109-02
Melphalan hydrochloride	—	KitIntravenous	Meitheal Pharmaceuticals Inc.	71288-132	71288-0132-90
Melphalan hydrochloride	—	Kit	Fosun Pharma USA Inc	72266-128	72266-0128-01

All 13 Melphalan hydrochloride NDCs

Other NDCs under ANDA 209826

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 209826
Product	Strength	Form · route	Labeler	Product NDC
Melphalan Hydrochloride	—	KitIntravenous	Sagent Pharmaceuticals	25021-258
Melphalan hydrochloride	—	Kit	Fosun Pharma USA Inc	72266-128