Prescription drug · ANDA
Pomalidomide NDC 69097-039
Pomalidomide 4 mg/1 · Capsule · Oral · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-039-07 | 69097003907 | 100 CAPSULE in 1 BOTTLE (69097-039-07)Marketed from Aug 30, 2026 | |
| 69097-039-81 | 69097003981 | 21 CAPSULE in 1 BOTTLE (69097-039-81)Marketed from Aug 30, 2026 |
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)
- Pomalidomide
- Generic name (nonproprietary)
- pomalidomide
- Active ingredients
- Pomalidomide — 4 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Cipla USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219718
- Marketing start
- Listing expires
- Identifiers
- Product ID 69097-039_d7629b96-2ace-4a2e-a70c-e73d41a990f9SPL ID d7629b96-2ace-4a2e-a70c-e73d41a990f9SPL set ID a0c16478-1a0c-4be0-be75-cb9e4543d71aRxCUI 1369718, 1369726, 1369730, 1369734UNII D2UX06XLB5UPC 0369097038076, 0369097036072
- 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
N469097003907followed by a unit qualifier and the quantityPackage 69097-0039-07. 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)
1. INDICATIONS AND USAGE Pomalidomide 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 219718
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 2 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-037 |
| Pomalidomide | Pomalidomide 1 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-036 |
| Pomalidomide | Pomalidomide 3 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-038 |