Prescription drug · ANDA
Pomalidomide NDC 0781-2369
Pomalidomide 4 mg/1 · Capsule · Oral · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-2369-27 | 00781236927 | 21 CAPSULE in 1 BOTTLE (0781-2369-27)Marketed from Sep 1, 2026 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Pomalidomide
- Generic name (nonproprietary)
- pomalidomide
- Active ingredients
- Pomalidomide — 4 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Sandoz Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 220741
- Marketing start
- Listing expires
- Identifiers
- Product ID 0781-2369_4fcd4978-b2d1-4d1a-b239-717cddb8be1fSPL ID 4fcd4978-b2d1-4d1a-b239-717cddb8be1fSPL set ID 4fcd4978-b2d1-4d1a-b239-717cddb8be1fRxCUI 1369718, 1369726, 1369730, 1369734UNII 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
N400781236927followed by a unit qualifier and the quantityPackage 00781-2369-27. 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 ). 1.1 Multiple Myeloma Pomalidomide capsules, in combination with dexamethasone, is indicated for adult 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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 220741
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 | Sandoz Inc | 0781-2354 |
| Pomalidomide | Pomalidomide 2 mg/1 | CapsuleOral | Sandoz Inc | 0781-2358 |
| Pomalidomide | Pomalidomide 3 mg/1 | CapsuleOral | Sandoz Inc | 0781-2366 |