Lenalidomide NDC 0378-1942

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-1942Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-1942Add 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
0378-1942-01	00378194201	100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1942-01)Marketed from Mar 7, 2023
0378-1942-21	00378194221	21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1942-21)Marketed from Mar 7, 2023

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 20 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213912
Marketing start: Sep 6, 2022
Listing expires: Dec 31, 2027
Identifiers: Product ID 0378-1942_3d041421-9aaf-4f7a-b5e2-b75899dc03c4SPL ID 3d041421-9aaf-4f7a-b5e2-b75899dc03c4SPL set ID 76f6c1e7-985b-43d9-892c-849df50ae80eRxCUI 602910, 602912, 643712, 643720, 1242231, 1428947UNII F0P408N6V4UPC 0303781935289
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

N400378194201 followed by a unit qualifier and the quantity

Package 00378-1942-01. 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 Oct 31, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Lenalidomide capsules are 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 rituximab product …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213912

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

FDA NDC Directory listings under ANDA 213912
Product	Strength	Form · route	Labeler	Product NDC
Lenalidomide	Lenalidomide 2.5 mg/1	CapsuleOral	Mylan Pharmaceuticals Inc.	0378-1935
Lenalidomide	Lenalidomide 5 mg/1	CapsuleOral	Mylan Pharmaceuticals Inc.	0378-1936
Lenalidomide	Lenalidomide 10 mg/1	CapsuleOral	Mylan Pharmaceuticals Inc.	0378-1937
Lenalidomide	Lenalidomide 25 mg/1	CapsuleOral	Mylan Pharmaceuticals Inc.	0378-1940
Lenalidomide	Lenalidomide 15 mg/1	CapsuleOral	Mylan Pharmaceuticals Inc.	0378-1941