Prescription drug · ANDA
Abiraterone (abiraterone acetate) NDC 82009-139
Abiraterone acetate 250 mg/1 · Tablet · Oral · Quallent Pharmaceuticals Health LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82009-139-12 | 82009013912 | 120 TABLET in 1 BOTTLE (82009-139-12)Marketed from Jun 15, 2024 |
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)
- Abiraterone
- Generic name (nonproprietary)
- abiraterone acetate
- Active ingredients
- Abiraterone acetate — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210686
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 17A1 Inhibitors (Mechanism)Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)
- Identifiers
- Product ID 82009-139_aefba59c-022d-4f26-a6e2-ffea0ab89f26SPL ID aefba59c-022d-4f26-a6e2-ffea0ab89f26SPL set ID 6f5b628b-69da-4a04-a4d5-623b18d1fd5dRxCUI 1100075, 1918042UNII EM5OCB9YJ6UPC 0382009140605, 0382009139128
- Pharmacologic class
- Cytochrome P450 17A1 Inhibitor
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
N482009013912followed by a unit qualifier and the quantityPackage 82009-0139-12. 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 .
Indications (excerpt from the label)
Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with • Metastatic castration-resistant prostate cancer (CRPC) • Metastatic high-risk castration-sensitive prostate cancer (CSPC) Abiraterone acetate tablet is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). (1) metastatic high-risk castration-sensitive prostate cancer (CSPC). ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210686
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 |
|---|---|---|---|---|
| Abirateroneabiraterone acetate | Abiraterone acetate 250 mg/1 | TabletOral | BluePoint Laboratories | 68001-489 |
| Abirateroneabiraterone acetate | Abiraterone acetate 250 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-284 |
| Abirateroneabiraterone acetate | Abiraterone acetate 500 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-285 |
| Abirateroneabiraterone acetate | Abiraterone acetate 500 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-140 |
| Abirateroneabiraterone acetate | Abiraterone acetate 250 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-030 |
| Abirateroneabiraterone acetate | Abiraterone acetate 500 mg/1 | TabletOral | BluePoint Laboratories | 68001-673 |