What is NDC 63304-044?

63304-044 is the product NDC for Lenalidomide, Lenalidomide 15 mg/1 capsule, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries, Inc., NDC labeler code 63304. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Lenalidomide?

107 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lenalidomide NDC 63304-044 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63304-044Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63304-0044Add 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
63304-044-01	63304004401	100 CAPSULE in 1 BOTTLE (63304-044-01)Marketed from Mar 4, 2023
63304-044-22	63304004422	21 CAPSULE in 1 BOTTLE (63304-044-22)Marketed from Mar 4, 2023

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): Lenalidomide
Generic name (nonproprietary): lenalidomide
Active ingredients: Lenalidomide — 15 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.NDC labeler code 63304
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211846
Marketing start: Mar 4, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 63304-044_2922537e-47de-b6b9-e063-6294a90a0f19SPL ID 2922537e-47de-b6b9-e063-6294a90a0f19SPL set ID 84d9dec7-9250-4dbd-9a0d-23e75f111892RxCUI 602910, 602912, 643712, 643720, 1242231, 1428947UNII F0P408N6V4
Pharmacologic class: Thalidomide Analog

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N463304004401 followed by a unit qualifier and the quantity

Package 63304-0044-01. 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 Dec 13, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Lenalidomide capsules are thalidomide analogue indicated for the treatment of adult patients with: Multiple myeloma (MM), in combination with dexamethasone (1.1). MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) (1.1). Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2). Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (1.3). Previously treated follicular lymphoma (FL), in combination with a rituximab product (1.4). Previously tr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63304-044

What is NDC 63304-044?: 63304-044 is the product NDC for Lenalidomide, Lenalidomide 15 mg/1 capsule, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Lenalidomide.
What is the active ingredient?: Lenalidomide.
Who is the labeler?: Sun Pharmaceutical Industries, Inc., NDC labeler code 63304. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lenalidomide?: 107 other product NDCs are listed under this name. See all Lenalidomide 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 Lenalidomide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Lenalidomide	Lenalidomide 2.5 mg/1	CapsuleOral	Accord Healthcare Inc.	16729-692	16729-0692-09
Lenalidomide	Lenalidomide 25 mg/1	CapsuleOral	Accord Healthcare Inc.	16729-697	16729-0697-06
Lenalidomide	Lenalidomide 15 mg/1	CapsuleOral	Accord Healthcare Inc.	16729-695	16729-0695-06
Lenalidomide	Lenalidomide 5 mg/1	CapsuleOral	Accord Healthcare Inc.	16729-693	16729-0693-09
Lenalidomide	Lenalidomide 20 mg/1	CapsuleOral	Accord Healthcare Inc.	16729-696	16729-0696-06
Lenalidomide	Lenalidomide 10 mg/1	CapsuleOral	Accord Healthcare Inc.	16729-694	16729-0694-09
Lenalidomide	Lenalidomide 2.5 mg/1	CapsuleOral	Padagis US LLC	0574-1402	00574-1402-28
Lenalidomide	Lenalidomide 5 mg/1	CapsuleOral	Padagis US LLC	0574-1405	00574-1405-28
Lenalidomide	Lenalidomide 10 mg/1	CapsuleOral	Padagis US LLC	0574-1410	00574-1410-28
Lenalidomide	Lenalidomide 15 mg/1	CapsuleOral	Padagis US LLC	0574-1415	00574-1415-21

All 108 Lenalidomide NDCs

Other NDCs under ANDA 211846

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

FDA NDC Directory listings under ANDA 211846
Product	Strength	Form · route	Labeler	Product NDC
Lenalidomide	Lenalidomide 10 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	63304-043
Lenalidomide	Lenalidomide 2.5 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	63304-041
Lenalidomide	Lenalidomide 5 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	63304-042
Lenalidomide	Lenalidomide 25 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	63304-046
Lenalidomide	Lenalidomide 20 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	63304-045