Prescription drug · NDA
Pomalyst (pomalidomide) NDC 59572-503
Pomalidomide 3 mg/1 · Capsule · Oral · Celgene Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59572-503-00 | 59572050300 | 100 CAPSULE in 1 BOTTLE (59572-503-00)Marketed from Feb 18, 2013 | |
| 59572-503-21 | 59572050321 | 21 CAPSULE in 1 BOTTLE (59572-503-21)Marketed from Feb 18, 2013 |
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)
- Pomalyst
- Generic name (nonproprietary)
- pomalidomide
- Active ingredients
- Pomalidomide — 3 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Celgene Corporation
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204026
- Marketing start
- Listing expires
- Identifiers
- Product ID 59572-503_4410582a-a5f3-429f-a7ca-5c17fb5560bfSPL ID 4410582a-a5f3-429f-a7ca-5c17fb5560bfSPL set ID 2b25ef01-5c9e-11e1-b86c-0800200c9a66RxCUI 1369718, 1369724, 1369726, 1369728, 1369730, 1369732, 1369734, 1369736UNII D2UX06XLB5
- 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
N459572050300followed by a unit qualifier and the quantityPackage 59572-0503-00. 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)
POMALYST is a thalidomide analogue indicated for the treatment of adult patients: • in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy ( 1.1 ). • with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical b…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 204026
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 |
|---|---|---|---|---|
| Pomalystpomalidomide | Pomalidomide 1 mg/1 | CapsuleOral | Celgene Corporation | 59572-501 |
| Pomalystpomalidomide | Pomalidomide 4 mg/1 | CapsuleOral | Celgene Corporation | 59572-504 |
| Pomalystpomalidomide | Pomalidomide 2 mg/1 | CapsuleOral | Celgene Corporation | 59572-502 |