Prescription drug · ANDA
lenalidomide NDC 76282-701
Lenalidomide 25 mg/1 · Capsule · Oral · EXELAN PHARMACEUTICALS INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-701-47 | 76282070147 | 21 CAPSULE in 1 BOTTLE, PLASTIC (76282-701-47)Marketed from Sep 6, 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 — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- EXELAN PHARMACEUTICALS INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210435
- Marketing start
- Listing expires
- Identifiers
- Product ID 76282-701_e6e7ab13-5475-4755-8e1a-f643425297b7SPL ID e6e7ab13-5475-4755-8e1a-f643425297b7SPL set ID 682e8a86-9f49-45db-a2ea-403ee1dc62d2RxCUI 602910, 602912, 643712, 643720, 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
N476282070147followed by a unit qualifier and the quantityPackage 76282-0701-47. 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 ). Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib ( 1.3 ). Previously treated follicular lymphoma (FL), in combination with a rituximab product ( 1.4 ). Previously …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210435
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 | Cipla USA Inc. | 69097-383 |
| lenalidomide | Lenalidomide 5 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-381 |
| lenalidomide | Lenalidomide 10 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-382 |
| lenalidomide | Lenalidomide 20 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-384 |
| lenalidomide | Lenalidomide 25 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-385 |
| lenalidomide | Lenalidomide 15 mg/1 | CapsuleOral | EXELAN PHARMACEUTICALS INC. | 76282-699 |
| lenalidomide | Lenalidomide 5 mg/1 | CapsuleOral | EXELAN PHARMACEUTICALS INC. | 76282-697 |
| lenalidomide | Lenalidomide 10 mg/1 | CapsuleOral | EXELAN PHARMACEUTICALS INC. | 76282-698 |
| lenalidomide | Lenalidomide 20 mg/1 | CapsuleOral | EXELAN PHARMACEUTICALS INC. | 76282-700 |