abiraterone acetate
- Product NDC
- 71921-178
- 11-digit product format
- 719210178
- Labeler code
- 71921
- Product ID
- 71921-178_38b4b689-c306-42a0-9df6-5b125314aaab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- abiraterone acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Florida Pharmaceutical Products, LLC.
- Application
- ANDA212462
- Marketing category
- ANDA
- Marketing start
- 2022-08-15
- 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
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 | 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 |
|---|
| 71921-178-20 | abiraterone acetate | 120 in 1 BOTTLE | TABLET | 120 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71921-178 | ABIRATERONE ACETATE TABLET [FLORIDA PHARMACEUTICAL PRODUCTS, LLC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20230429_b3e7f851-4132-4003-8f14-0eea21e5009c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71921-178-20 | 71921017820 | 120 TABLET in 1 BOTTLE (71921-178-20) | 120 tablet | 2022-08-15 | 0000-00-00 | No | No | Current |