Prescription drug · ANDA
Pomalidomide NDC 63850-0132
Pomalidomide 2 mg/1 · Capsule · Oral · Natco Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63850-0132-1 | 63850013201 | 21 CAPSULE in 1 BOTTLE (63850-0132-1)Marketed from Nov 1, 2025 | |
| 63850-0132-2 | 63850013202 | 100 CAPSULE in 1 BOTTLE (63850-0132-2)Marketed from Nov 1, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Pomalidomide
- Generic name (nonproprietary)
- pomalidomide
- Active ingredients
- Pomalidomide — 2 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Natco Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210111
- Marketing start
- Listing expires
- Identifiers
- Product ID 63850-0132_0169dbda-53df-4cd9-b989-ff7544f1bdf5SPL ID 0169dbda-53df-4cd9-b989-ff7544f1bdf5SPL set ID 0169dbda-53df-4cd9-b989-ff7544f1bdf5RxCUI 1369718, 1369726, 1369730, 1369734UNII D2UX06XLB5UPC 0363850013416, 0363850013317, 0363850013126, 0363850013225, 0363850013218, 0363850013324, 0363850013423, 0363850013119
- 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
N463850013201followed by a unit qualifier and the quantityPackage 63850-0132-01. 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)
Pomalidomide capsules are 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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210111
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 |
|---|---|---|---|---|
| Pomalidomide | Pomalidomide 1 mg/1 | CapsuleOral | Natco Pharma Limited | 63850-0131 |
| Pomalidomide | Pomalidomide 3 mg/1 | CapsuleOral | Natco Pharma Limited | 63850-0133 |
| Pomalidomide | Pomalidomide 4 mg/1 | CapsuleOral | Natco Pharma Limited | 63850-0134 |
| Pomalidomide | Pomalidomide 4 mg/1 | CapsuleOral | Breckenridge Pharmaceutical, Inc. | 51991-346 |
| Pomalidomide | Pomalidomide 1 mg/1 | CapsuleOral | Breckenridge Pharmaceutical, Inc. | 51991-342 |
| Pomalidomide | Pomalidomide 2 mg/1 | CapsuleOral | Breckenridge Pharmaceutical, Inc. | 51991-343 |
| Pomalidomide | Pomalidomide 3 mg/1 | CapsuleOral | Breckenridge Pharmaceutical, Inc. | 51991-344 |