Abiraterone
- Product NDC
- 72205-285
- 11-digit product format
- 722050285
- Labeler code
- 72205
- Product ID
- 72205-285_a87a3fa5-28cb-42be-9039-af800a7c482c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Abiraterone acetate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Novadoz Pharmaceuticals LLC
- Application
- ANDA210686
- Marketing category
- ANDA
- Marketing start
- 2024-04-24
- Substance
- ABIRATERONE ACETATE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| EM5OCB9YJ6 | ABIRATERONE ACETATE | 154229-18-2 | ABIRATERONE ACETATE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72205-285-05 | 72205028505 | 500 TABLET, FILM COATED in 1 BOTTLE (72205-285-05) | 2024-05-24 | No | No | Historical |
| 72205-285-60 | 72205028560 | 60 TABLET, FILM COATED in 1 BOTTLE (72205-285-60) | 2024-05-24 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Abiraterone | Novadoz Pharmaceuticals LLC | MSN LABORATORIES PRIVATE LIMITED | MSN Pharmaceuticals Inc. | 2025-11-12 | Human Prescription Drug Label | 5 |
| Abiraterone | Novadoz Pharmaceuticals LLC | MSN LABORATORIES PRIVATE LIMITED | 2024-05-23 | Human Prescription Drug Label | 4 |