Abiraterone acetate
- Product NDC
- 71921-177
- 11-digit product format
- 719210177
- Labeler code
- 71921
- Product ID
- 71921-177_2b8d3621-3b8b-286c-e063-6294a90a7ac2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Abiraterone acetate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Florida Pharmaceutical Products, LLC
- Application
- ANDA215086
- Marketing category
- ANDA
- Marketing start
- 2023-04-10
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Abiraterone acetate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ABIRATERONE ACETATE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | EM5OCB9YJ6 |
| Rxcui | 1918042 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71921-177-06 | Abiraterone acetate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71921-177 | ABIRATERONE ACETATE TABLET, FILM COATED [FLORIDA PHARMACEUTICAL PRODUCTS, LLC] | 3 | Current NDC, 1 package rows | 20250114_68121a71-5024-4f9e-bd9c-2d412f6a6355.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71921-177-06 | 71921017706 | 60 TABLET, FILM COATED in 1 BOTTLE (71921-177-06) | 2023-04-10 | No | No | Current |