Prescription drug · ANDA
Abiraterone (abiraterone acetate) NDC 72205-285
Abiraterone acetate 500 mg/1 · Tablet, Film coated · Oral · Novadoz Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72205-285-05 | 72205028505 | 500 TABLET, FILM COATED in 1 BOTTLE (72205-285-05)Marketed from May 24, 2024 | |
| 72205-285-60 | 72205028560 | 60 TABLET, FILM COATED in 1 BOTTLE (72205-285-60)Marketed from May 24, 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 — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Novadoz Pharmaceuticals LLC
- 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 72205-285_a87a3fa5-28cb-42be-9039-af800a7c482cSPL ID a87a3fa5-28cb-42be-9039-af800a7c482cSPL set ID 88d05db3-8bdc-47f1-bb00-6b4a71f98609RxCUI 1100075, 1918042UNII EM5OCB9YJ6UPC 0372205284050, 0372205284920, 0372205030923, 0372205285057, 0372205285606
- 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
N472205028505followed by a unit qualifier and the quantityPackage 72205-0285-05. 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 250 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-139 |
| 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 |