Prescription drug · ANDA
Pomalidomide NDC 63850-0131
Pomalidomide 1 mg/1 · Capsule · Oral · Natco Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63850-0131-1 | 6385001310163850013101 | 21 CAPSULE in 1 BOTTLE (63850-0131-1)Marketed from Nov 1, 2025 | |
| 63850-0131-2 | 6385001310263850013102 | 100 CAPSULE in 1 BOTTLE (63850-0131-2)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 — 1 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Natco Pharma LimitedNDC labeler code 63850
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210111
- Marketing start
- Listing expires
- Identifiers
- Product ID 63850-0131_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
N463850013101followed by a unit qualifier and the quantityPackage 63850-0131-01. 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.
About NDC 63850-0131
- What is NDC 63850-0131?
- 63850-0131 is the product NDC for Pomalidomide, Pomalidomide 1 mg/1 capsule, listed with the FDA by Natco Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pomalidomide.
- What is the active ingredient?
- Pomalidomide.
- Who is the labeler?
- Natco Pharma Limited, NDC labeler code 63850. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pomalidomide?
- 42 other product NDCs are listed under this name. See all Pomalidomide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pomalidomide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| pomalidomide | Pomalidomide 2 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-177 | 72205-0177-2172205-0177-91 |
| pomalidomide | Pomalidomide 3 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-178 | 72205-0178-2172205-0178-91 |
| pomalidomide | Pomalidomide 4 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-179 | 72205-0179-2172205-0179-91 |
| Pomalidomide | Pomalidomide 1 mg/1 | CapsuleOral | Sandoz Inc | 0781-2354 | 00781-2354-27 |
| Pomalidomide | Pomalidomide 2 mg/1 | CapsuleOral | Sandoz Inc | 0781-2358 | 00781-2358-27 |
| Pomalidomide | Pomalidomide 3 mg/1 | CapsuleOral | Sandoz Inc | 0781-2366 | 00781-2366-27 |
| Pomalidomide | Pomalidomide 4 mg/1 | CapsuleOral | Sandoz Inc | 0781-2369 | 00781-2369-27 |
| pomalidomide | Pomalidomide 4 mg/1 | CapsuleOral | Dr. Reddy's Laboratories Inc. | 43598-517 | 43598-0517-0143598-0517-21 |
| pomalidomide | Pomalidomide 3 mg/1 | CapsuleOral | Dr. Reddy's Laboratories Inc. | 43598-518 | 43598-0518-0143598-0518-21 |
| pomalidomide | Pomalidomide 2 mg/1 | CapsuleOral | Dr. Reddy's Laboratories Inc. | 43598-519 | 43598-0519-0143598-0519-21 |
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 | 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 |
| Pomalidomide | Pomalidomide 4 mg/1 | CapsuleOral | Breckenridge Pharmaceutical, Inc. | 51991-346 |
| Pomalidomide | Pomalidomide 2 mg/1 | CapsuleOral | Natco Pharma Limited | 63850-0132 |
| Pomalidomide | Pomalidomide 3 mg/1 | CapsuleOral | Natco Pharma Limited | 63850-0133 |
| Pomalidomide | Pomalidomide 4 mg/1 | CapsuleOral | Natco Pharma Limited | 63850-0134 |