Prescription drug · NDA
Revlimid (Lenalidomide) NDC 59572-425
Lenalidomide 25 mg/1 · Capsule · Oral · Celgene Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59572-425-00 | 59572042500 | 100 CAPSULE in 1 BOTTLE (59572-425-00)Marketed from Jul 7, 2006 | |
| 59572-425-21 | 59572042521 | 21 CAPSULE in 1 BOTTLE (59572-425-21)Marketed from Mar 3, 2009 |
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)
- Revlimid
- Generic name (nonproprietary)
- lenalidomide
- Active ingredients
- Lenalidomide — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Celgene CorporationNDC labeler code 59572
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021880
- Marketing start
- Listing expires
- Identifiers
- Product ID 59572-425_9329fd28-b848-4013-92e0-a68270328336SPL ID 9329fd28-b848-4013-92e0-a68270328336SPL set ID 5fa97bf5-28a2-48f1-8955-f56012d296beRxCUI 602910, 602912, 616114, 616116, 643712, 643714, 643720, 643722, 1242231, 1242233, 1428947, 1429367UNII F0P408N6V4UPC 0359572420212, 0359572402287, 0359572425217, 0359572410282, 0359572405288
- 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
N459572042500followed by a unit qualifier and the quantityPackage 59572-0425-00. 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)
REVLIMID 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 ). • Pre…
Excerpt only. Read the full label for complete information.
About NDC 59572-425
- What is NDC 59572-425?
- 59572-425 is the product NDC for Revlimid (lenalidomide), Lenalidomide 25 mg/1 capsule, listed with the FDA by Celgene Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Revlimid (Lenalidomide).
- What is the active ingredient?
- Lenalidomide.
- Who is the labeler?
- Celgene Corporation, NDC labeler code 59572. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Revlimid?
- 5 other product NDCs are listed under this name. See all Revlimid NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Revlimid products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Revlimidlenalidomide | Lenalidomide 20 mg/1 | CapsuleOral | Celgene Corporation | 59572-420 | 59572-0420-0059572-0420-21 |
| Revlimidlenalidomide | Lenalidomide 2.5 mg/1 | CapsuleOral | Celgene Corporation | 59572-402 | 59572-0402-0059572-0402-28 |
| Revlimidlenalidomide | Lenalidomide 15 mg/1 | CapsuleOral | Celgene Corporation | 59572-415 | 59572-0415-0059572-0415-21 |
| Revlimidlenalidomide | Lenalidomide 5 mg/1 | CapsuleOral | Celgene Corporation | 59572-405 | 59572-0405-0059572-0405-28 |
| Revlimidlenalidomide | Lenalidomide 10 mg/1 | CapsuleOral | Celgene Corporation | 59572-410 | 59572-0410-0059572-0410-28 |
Other NDCs under NDA 021880
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 |
|---|---|---|---|---|
| Revlimidlenalidomide | Lenalidomide 2.5 mg/1 | CapsuleOral | Celgene Corporation | 59572-402 |
| Revlimidlenalidomide | Lenalidomide 20 mg/1 | CapsuleOral | Celgene Corporation | 59572-420 |
| Revlimidlenalidomide | Lenalidomide 5 mg/1 | CapsuleOral | Celgene Corporation | 59572-405 |
| Revlimidlenalidomide | Lenalidomide 10 mg/1 | CapsuleOral | Celgene Corporation | 59572-410 |
| Revlimidlenalidomide | Lenalidomide 15 mg/1 | CapsuleOral | Celgene Corporation | 59572-415 |