Prescription drug · ANDA
Lenalidomide NDC 60219-1718
Lenalidomide 20 mg/1 · Capsule · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60219-1718-1 | 60219171801 | 21 CAPSULE in 1 BOTTLE (60219-1718-1)Marketed from Feb 12, 2025 | |
| 60219-1718-2 | 60219171802 | 100 CAPSULE in 1 BOTTLE (60219-1718-2)Marketed from Feb 12, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Amneal Pharmaceuticals NY LLCNDC labeler code 60219
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216213
- Marketing start
- Listing expires
- Identifiers
- Product ID 60219-1718_85e664d1-1d56-4b9b-b2a1-96b32b5b1a7eSPL ID 85e664d1-1d56-4b9b-b2a1-96b32b5b1a7eSPL set ID da7b5dda-79ed-4c4a-88aa-52394fdc7c54RxCUI 602910, 602912, 643712, 643720, 1242231, 1428947UNII F0P408N6V4UPC 0360219171619
- 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
N460219171801followed by a unit qualifier and the quantityPackage 60219-1718-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
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 ) Limitations of Use: Lenalidomide capsules is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials. 1.1 Multiple Myeloma Lenalidomide capsules in combi…
Excerpt only. Read the full label for complete information.
About NDC 60219-1718
- What is NDC 60219-1718?
- 60219-1718 is the product NDC for Lenalidomide, Lenalidomide 20 mg/1 capsule, listed with the FDA by Amneal Pharmaceuticals NY LLC. 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?
- Amneal Pharmaceuticals NY LLC, NDC labeler code 60219. 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.
Related NDCs: other Lenalidomide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lenalidomide | Lenalidomide 25 mg/1 | CapsuleOral | Accord Healthcare Inc. | 16729-697 | 16729-0697-06 |
| Lenalidomide | Lenalidomide 2.5 mg/1 | CapsuleOral | Accord Healthcare Inc. | 16729-692 | 16729-0692-09 |
| Lenalidomide | Lenalidomide 15 mg/1 | CapsuleOral | Accord Healthcare Inc. | 16729-695 | 16729-0695-06 |
| Lenalidomide | Lenalidomide 20 mg/1 | CapsuleOral | Accord Healthcare Inc. | 16729-696 | 16729-0696-06 |
| Lenalidomide | Lenalidomide 5 mg/1 | CapsuleOral | Accord Healthcare Inc. | 16729-693 | 16729-0693-09 |
| Lenalidomide | Lenalidomide 10 mg/1 | CapsuleOral | Accord Healthcare Inc. | 16729-694 | 16729-0694-09 |
| Lenalidomide | Lenalidomide 25 mg/1 | CapsuleOral | Padagis US LLC | 0574-1425 | 00574-1425-21 |
| Lenalidomide | Lenalidomide 5 mg/1 | CapsuleOral | Devatis Inc. | 73043-039 | 73043-0039-0173043-0039-28 |
| Lenalidomide | Lenalidomide 2.5 mg/1 | CapsuleOral | Devatis Inc. | 73043-038 | 73043-0038-0173043-0038-28 |
| Lenalidomide | Lenalidomide 25 mg/1 | CapsuleOral | Devatis Inc. | 73043-043 | 73043-0043-0173043-0043-21 |
Other NDCs under ANDA 216213
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Lenalidomide | Lenalidomide 15 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1717 |
| Lenalidomide | Lenalidomide 2.5 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1714 |
| Lenalidomide | Lenalidomide 5 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1715 |
| Lenalidomide | Lenalidomide 10 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1716 |
| Lenalidomide | Lenalidomide 25 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1719 |