Prescription drug · ANDA
Lenalidomide NDC 59651-346
Lenalidomide 20 mg/1 · Capsule · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-346-01 | 59651034601 | 100 CAPSULE in 1 BOTTLE (59651-346-01)Marketed from Mar 6, 2023 | |
| 59651-346-07 | 59651034607 | 1 BLISTER PACK in 1 CARTON (59651-346-07) / 7 CAPSULE in 1 BLISTER PACKMarketed from Mar 6, 2023 | |
| 59651-346-21 | 59651034621 | 21 CAPSULE in 1 BOTTLE (59651-346-21)Marketed from Mar 6, 2023 |
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 — 20 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213885
- Marketing start
- Listing expires
- Identifiers
- Product ID 59651-346_f022fe20-76ac-4825-8986-6e1ec95b0b21SPL ID f022fe20-76ac-4825-8986-6e1ec95b0b21SPL set ID 51bfdd53-8fd9-4f86-bebe-75de29e6379dRxCUI 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
N459651034601followed by a unit qualifier and the quantityPackage 59651-0346-01. 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 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 Lenalidomide capsule…
Excerpt only. Read the full label for complete information.
About NDC 59651-346
- What is NDC 59651-346?
- 59651-346 is the product NDC for Lenalidomide, Lenalidomide 20 mg/1 capsule, listed with the FDA by Aurobindo Pharma Limited. It has 3 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?
- Aurobindo Pharma Limited, NDC labeler code 59651. 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 213885
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 | Aurobindo Pharma Limited | 59651-343 |
| Lenalidomide | Lenalidomide 2.5 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-342 |
| Lenalidomide | Lenalidomide 25 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-347 |
| Lenalidomide | Lenalidomide 10 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-344 |
| Lenalidomide | Lenalidomide 15 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-345 |