Prescription drug · ANDA
Abiraterone Acetate (abiraterone) NDC 69238-1754
Abiraterone acetate 500 mg/1 · Tablet · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1754-6 | 69238175406 | 60 TABLET in 1 BOTTLE (69238-1754-6)Marketed from Jan 7, 2019 |
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)
- Abiraterone Acetate
- Generic name (nonproprietary)
- abiraterone
- Active ingredients
- Abiraterone acetate — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208327
- 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 69238-1754_c03e6ebe-681b-40c0-b123-741dd35fd558SPL ID c03e6ebe-681b-40c0-b123-741dd35fd558SPL set ID c9eb9b46-f847-40a8-802c-a51b40406d5aRxCUI 1100075, 1918042UNII EM5OCB9YJ6UPC 0369238116571, 0369238175462
- 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
N469238175406followed by a unit qualifier and the quantityPackage 69238-1754-06. 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 tablets are 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 208327
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 |
|---|---|---|---|---|
| Abiraterone Acetateabiraterone | Abiraterone acetate 250 mg/1 | TabletOral | AvKARE | 42291-024 |
| Abiraterone Acetateabiraterone | Abiraterone acetate 250 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 69238-1165 |
| Abiraterone Acetateabiraterone | Abiraterone acetate 500 mg/1 | TabletOral | AvKARE | 42291-073 |
| Abiraterone Acetateabiraterone | Abiraterone acetate 250 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 60219-1165 |
| Abiraterone Acetateabiraterone | Abiraterone acetate 500 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 60219-1754 |
| Abiraterone Acetateabiraterone | Abiraterone acetate 250 mg/1 | TabletOral | American Health Packaging | 60687-790 |