Prescription drug · ANDA
lenalidomide NDC 69097-382
Lenalidomide 10 mg/1 · Capsule · Oral · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-382-73 | 6909703827369097038273 | 28 CAPSULE in 1 BOTTLE, PLASTIC (69097-382-73)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 — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Cipla USA Inc.NDC labeler code 69097
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210435
- Marketing start
- Listing expires
- Identifiers
- Product ID 69097-382_6b77715c-f6f7-408c-8efd-bfdd3125aec4SPL ID 6b77715c-f6f7-408c-8efd-bfdd3125aec4SPL set ID ba2a07fd-ca60-40bc-b79b-9caf81900fa3RxCUI 602910, 602912, 643712, 643720, 1428947UNII F0P408N6V4UPC 0369097383817, 0369097382735, 0369097385811, 0369097384814
- 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
N469097038273followed by a unit qualifier and the quantityPackage 69097-0382-73. 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.
About NDC 69097-382
- What is NDC 69097-382?
- 69097-382 is the product NDC for lenalidomide, Lenalidomide 10 mg/1 capsule, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, 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?
- Cipla USA Inc., NDC labeler code 69097. 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 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 5 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-381 |
| lenalidomide | Lenalidomide 15 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-383 |
| lenalidomide | Lenalidomide 20 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-384 |
| lenalidomide | Lenalidomide 25 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-385 |
| lenalidomide | Lenalidomide 5 mg/1 | CapsuleOral | EXELAN PHARMACEUTICALS INC. | 76282-697 |
| lenalidomide | Lenalidomide 10 mg/1 | CapsuleOral | EXELAN PHARMACEUTICALS INC. | 76282-698 |
| lenalidomide | Lenalidomide 15 mg/1 | CapsuleOral | EXELAN PHARMACEUTICALS INC. | 76282-699 |
| lenalidomide | Lenalidomide 20 mg/1 | CapsuleOral | EXELAN PHARMACEUTICALS INC. | 76282-700 |
| lenalidomide | Lenalidomide 25 mg/1 | CapsuleOral | EXELAN PHARMACEUTICALS INC. | 76282-701 |