Abiraterone
- Product NDC
- 0143-9597
- 11-digit product format
- 001439597
- Labeler code
- 0143
- Product ID
- 0143-9597_35e5846f-9299-4190-94bb-6b0bb0d92485
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Abiraterone acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Abiraterone
- 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 |
|---|
| 0143-9597-21 | Abiraterone | 120 in 1 BOTTLE | TABLET | 120 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9597 | ABIRATERONE (ABIRATERONE ACETATE) TABLET [HIKMA PHARMACEUTICALS USA INC.] | 16 | Current NDC, Legacy NDC, 1 package rows | 20250430_be29365a-ed25-44c0-9818-e9016dc95ba6.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 |
|---|
| 0143-9597-21 | 00143959721 | 120 TABLET in 1 BOTTLE (0143-9597-21) | 120 tablet | 2018-11-23 | 0000-00-00 | No | No | Current |