Abiraterone Acetate
- Product NDC
- 50268-032
- 11-digit product format
- 502680032
- Labeler code
- 50268
- Product ID
- 50268-032_5108abe6-98f5-ce57-e063-6394a90aef2f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Abiraterone Acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA208416
- Marketing category
- ANDA
- Marketing start
- 2026-05-04
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Abiraterone Acetate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ABIRATERONE ACETATE | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | EM5OCB9YJ6 |
| Rxcui | 1100075 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50268-032-11 | Abiraterone Acetate | 1 in 1 BLISTER PACK | TABLET | 1 | | 1 |
| 50268-032-12 | Abiraterone Acetate | 20 in 1 BOX | TABLET | 20 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50268-032-11 | 50268003211 | 1 in 1 BLISTER PACK | | | | | Historical |
| 50268-032-12 | 50268003212 | 20 BLISTER PACK in 1 BOX (50268-032-12) / 1 TABLET in 1 BLISTER PACK (50268-032-11) | 20 blister pack | 2026-05-04 | No | No | Current |