Abiraterone Acetate
- Product NDC
- 43598-468
- 11-digit product format
- 435980468
- Labeler code
- 43598
- Product ID
- 43598-468_5e7f1aec-5727-4e71-1a05-55e8eef89e0a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Abiraterone Acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dr. Reddys Laboratories Inc
- Application
- ANDA208416
- Marketing category
- ANDA
- Marketing start
- 2023-09-11
- 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 43598-468-38 | 43598046838 | 6 BLISTER PACK in 1 CARTON (43598-468-38) / 10 TABLET in 1 BLISTER PACK (43598-468-79) | 6 blister pack | 2023-09-11 | No | No | Historical |
| 43598-468-60 | 43598046860 | 60 TABLET in 1 BOTTLE (43598-468-60) | 60 tablet | 2023-09-11 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Abiraterone Acetate | Dr. Reddys Laboratories Inc | Dr.Reddy's Laboratories Limited FTO-7 | Dr. Reddy's Laboratories Limited - FTO III | 2023-09-04 | HUMAN PRESCRIPTION DRUG LABEL | 18 |