Prescription drug · ANDA
Abiraterone Acetate (abiraterone) NDC 60219-1165
Abiraterone acetate 250 mg/1 · Tablet · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60219-1165-7 | 60219116507 | 120 TABLET in 1 BOTTLE (60219-1165-7)Marketed from Apr 28, 2023 |
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 — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLC
- 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 60219-1165_7bb0d9aa-97d5-483c-9ab8-2f2fff30cbcdSPL ID 7bb0d9aa-97d5-483c-9ab8-2f2fff30cbcdSPL set ID 6fda6b92-59ed-4180-af68-94052a5e82cfRxCUI 1100075, 1918042UNII EM5OCB9YJ6UPC 0360219175464, 0360219116573
- 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
N460219116507followed by a unit qualifier and the quantityPackage 60219-1165-07. 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 .
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 500 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 60219-1754 |
| Abiraterone Acetateabiraterone | Abiraterone acetate 500 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 69238-1754 |
| Abiraterone Acetateabiraterone | Abiraterone acetate 250 mg/1 | TabletOral | American Health Packaging | 60687-790 |