Prescription drug · ANDA
Lenalidomide NDC 73043-039
Lenalidomide 5 mg/1 · Capsule · Oral · Devatis Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73043-039-01 | 73043003901 | 100 CAPSULE in 1 BOTTLE (73043-039-01)Marketed from Jan 31, 2026 | |
| 73043-039-28 | 73043003928 | 28 CAPSULE in 1 BOTTLE (73043-039-28)Marketed from Jan 31, 2026 |
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 — 5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Devatis Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217554
- Marketing start
- Listing expires
- Identifiers
- Product ID 73043-039_0835d82d-196b-4ec8-aa3b-adb7fe501aa2SPL ID 0835d82d-196b-4ec8-aa3b-adb7fe501aa2SPL set ID 9959cd7e-12b6-4b59-8205-d5f6e7e7d09bRxCUI 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
N473043003901followed by a unit qualifier and the quantityPackage 73043-0039-01. 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 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 orprogressed after two prior therapies, one of which included bortezomib ( 1.3 ). Previously treated follicular lymphoma (FL), in combination with a rituximab product ( 1.4 ). Pr…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217554
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 10 mg/1 | CapsuleOral | Devatis Inc. | 73043-040 |
| Lenalidomide | Lenalidomide 2.5 mg/1 | CapsuleOral | Devatis Inc. | 73043-038 |
| Lenalidomide | Lenalidomide 15 mg/1 | CapsuleOral | Devatis Inc. | 73043-041 |
| Lenalidomide | Lenalidomide 20 mg/1 | CapsuleOral | Devatis Inc. | 73043-042 |
| Lenalidomide | Lenalidomide 25 mg/1 | CapsuleOral | Devatis Inc. | 73043-043 |