Lenalidomide NDC 43598-513

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-513Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0513Add 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
43598-513-01	43598051301	100 CAPSULE in 1 BOTTLE (43598-513-01)Marketed from Sep 7, 2022
43598-513-21	43598051321	21 CAPSULE in 1 BOTTLE (43598-513-21)Marketed from Sep 7, 2022

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: Dr. Reddy's Laboratories Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209348
Marketing start: Sep 7, 2022
Listing expires: Dec 31, 2026
Identifiers: Product ID 43598-513_023f2dc9-b878-9d13-44d0-894310c6b8daSPL ID 023f2dc9-b878-9d13-44d0-894310c6b8daSPL set ID ca8cc2cc-c856-e676-4f60-1e46d7b53d73RxCUI 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

N443598051301 followed by a unit qualifier and the quantity

Package 43598-0513-01. 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 Apr 30, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

1 IND ICATIONS AND USAGE Lenalidomide is a 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 rit…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209348

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

FDA NDC Directory listings under ANDA 209348
Product	Strength	Form · route	Labeler	Product NDC
Lenalidomide	Lenalidomide 20 mg/1	CapsuleOral	Dr. Reddy's Laboratories Inc.	43598-514
Lenalidomide	Lenalidomide 5 mg/1	CapsuleOral	Dr. Reddy's Laboratories Inc.	43598-511
Lenalidomide	Lenalidomide 10 mg/1	CapsuleOral	Dr. Reddy's Laboratories Inc.	43598-512
Lenalidomide	Lenalidomide 25 mg/1	CapsuleOral	Dr. Reddy's Laboratories Inc.	43598-515
Lenalidomide	Lenalidomide 2.5 mg/1	CapsuleOral	Dr. Reddy's Laboratories Inc.	43598-516