Prescription drug · ANDA
Lenalidomide NDC 0574-1402
Lenalidomide 2.5 mg/1 · Capsule · Oral · Padagis US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0574-1402-28 | 00574140228 | 28 CAPSULE in 1 BOTTLE (0574-1402-28)Marketed from Jan 31, 2026 |
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 — 2.5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Padagis US LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217265
- Marketing start
- Listing expires
- Identifiers
- Product ID 0574-1402_dffe719b-4f61-47e2-b71c-673322d487f5SPL ID dffe719b-4f61-47e2-b71c-673322d487f5SPL set ID dffe719b-4f61-47e2-b71c-673322d487f5RxCUI 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
N400574140228followed by a unit qualifier and the quantityPackage 00574-1402-28. 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 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 ). Limitations of Use: • Lenalidomide capsules are not indicated and are not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials ( 1.6 ). 1.1 Multiple Myeloma Le…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217265
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 5 mg/1 | CapsuleOral | Padagis US LLC | 0574-1405 |
| Lenalidomide | Lenalidomide 10 mg/1 | CapsuleOral | Padagis US LLC | 0574-1410 |
| Lenalidomide | Lenalidomide 15 mg/1 | CapsuleOral | Padagis US LLC | 0574-1415 |
| Lenalidomide | Lenalidomide 20 mg/1 | CapsuleOral | Padagis US LLC | 0574-1420 |
| Lenalidomide | Lenalidomide 25 mg/1 | CapsuleOral | Padagis US LLC | 0574-1425 |