Abiraterone
- Product NDC
- 72789-213
- 11-digit product format
- 727890213
- Labeler code
- 72789
- Product ID
- 72789-213_40ac0f51-34ed-e949-e063-6294a90a2366
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Abiraterone acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA208339
- Marketing category
- ANDA
- Marketing start
- 2018-11-23
- Substance
- ABIRATERONE ACETATE
- Active strength
- 250 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-213-98 | 72789021398 | 120 TABLET in 1 BOTTLE, PLASTIC (72789-213-98) | 120 tablet | 2021-10-11 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Abiraterone | PD-Rx Pharmaceuticals, Inc. | 2025-10-08 | HUMAN PRESCRIPTION DRUG LABEL | 16 |
| Abiraterone | PD-Rx Pharmaceuticals, Inc. | 2024-09-04 | HUMAN PRESCRIPTION DRUG LABEL | 15 |