Abiraterone
- Product NDC
- 82249-010
- 11-digit product format
- 822490010
- Labeler code
- 82249
- Product ID
- 82249-010_e3758cee-2504-46be-8eb0-67463e7fe6ed
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Abiraterone acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- CivicaScript, LLC
- 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 |
|---|
| 82249-010-12 | Abiraterone | 120 in 1 BOTTLE, PLASTIC | TABLET | 120 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82249-010 | ABIRATERONE (ABIRATERONE ACETATE) TABLET [CIVICASCRIPT, LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20241109_0ef857ee-2bfc-4d27-a417-ad58fc3a6ff6.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 |
|---|
| 82249-010-12 | 82249001012 | 120 TABLET in 1 BOTTLE, PLASTIC (82249-010-12) | 120 tablet | 2022-06-27 | 0000-00-00 | No | No | Current |