Prescription drug · ANDA
Lenalidomide NDC 47781-485
Lenalidomide 10 mg/1 · Capsule · Oral · Alvogen, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47781-485-01 | 4778104850147781048501 | 100 CAPSULE in 1 BOTTLE (47781-485-01)Marketed from Sep 3, 2022 | |
| 47781-485-28 | 4778104852847781048528 | 28 CAPSULE in 1 BOTTLE (47781-485-28)Marketed from Sep 3, 2022 |
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 — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Alvogen, Inc.NDC labeler code 47781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210480
- Marketing start
- Listing expires
- Identifiers
- Product ID 47781-485_1c3e5289-7ff0-54c1-9146-f7ec3f49aea2SPL ID 1c3e5289-7ff0-54c1-9146-f7ec3f49aea2SPL set ID adee5af1-c9ab-c0c7-e400-dea7d2a0d4beRxCUI 602910, 602912, 643712, 643720, 1242231, 1428947UNII F0P408N6V4UPC 0347781488772, 0347781483289, 0347781485283, 0347781487775, 0347781484286, 0347781486778
- 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
N447781048501followed by a unit qualifier and the quantityPackage 47781-0485-01. 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 ). 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 capsules in combination with dexamethasone are indicated for the treatment of adult patients with …
Excerpt only. Read the full label for complete information.
About NDC 47781-485
- What is NDC 47781-485?
- 47781-485 is the product NDC for Lenalidomide, Lenalidomide 10 mg/1 capsule, listed with the FDA by Alvogen, Inc.. 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?
- Alvogen, Inc., NDC labeler code 47781. 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 2.5 mg/1 | CapsuleOral | Accord Healthcare Inc. | 16729-692 | 16729-0692-09 |
| Lenalidomide | Lenalidomide 25 mg/1 | CapsuleOral | Accord Healthcare Inc. | 16729-697 | 16729-0697-06 |
| Lenalidomide | Lenalidomide 15 mg/1 | CapsuleOral | Accord Healthcare Inc. | 16729-695 | 16729-0695-06 |
| Lenalidomide | Lenalidomide 5 mg/1 | CapsuleOral | Accord Healthcare Inc. | 16729-693 | 16729-0693-09 |
| Lenalidomide | Lenalidomide 20 mg/1 | CapsuleOral | Accord Healthcare Inc. | 16729-696 | 16729-0696-06 |
| Lenalidomide | Lenalidomide 10 mg/1 | CapsuleOral | Accord Healthcare Inc. | 16729-694 | 16729-0694-09 |
| Lenalidomide | Lenalidomide 2.5 mg/1 | CapsuleOral | Padagis US LLC | 0574-1402 | 00574-1402-28 |
| Lenalidomide | Lenalidomide 5 mg/1 | CapsuleOral | Padagis US LLC | 0574-1405 | 00574-1405-28 |
| Lenalidomide | Lenalidomide 10 mg/1 | CapsuleOral | Padagis US LLC | 0574-1410 | 00574-1410-28 |
| Lenalidomide | Lenalidomide 15 mg/1 | CapsuleOral | Padagis US LLC | 0574-1415 | 00574-1415-21 |
Other NDCs under ANDA 210480
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 2.5 mg/1 | CapsuleOral | Alvogen, Inc. | 47781-483 |
| Lenalidomide | Lenalidomide 5 mg/1 | CapsuleOral | Alvogen, Inc. | 47781-484 |
| Lenalidomide | Lenalidomide 15 mg/1 | CapsuleOral | Alvogen, Inc. | 47781-486 |
| Lenalidomide | Lenalidomide 20 mg/1 | CapsuleOral | Alvogen, Inc. | 47781-487 |
| Lenalidomide | Lenalidomide 25 mg/1 | CapsuleOral | Alvogen, Inc. | 47781-488 |