Abiraterone acetate
- Product NDC
- 64980-418
- 11-digit product format
- 649800418
- Labeler code
- 64980
- Product ID
- 64980-418_36a3afb4-e212-4881-865f-90349c009e70
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Abiraterone acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA208371
- Marketing category
- ANDA
- Marketing start
- 2019-02-25
- 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 |
|---|
| 64980-418-12 | Abiraterone acetate | 120 in 1 BOTTLE | TABLET | 120 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64980-418 | ABIRATERONE ACETATE TABLET [RISING PHARMA HOLDINGS, INC.] | 13 | Current NDC, Legacy NDC, 1 package rows | 20240927_54ae5ef9-aea5-484a-a473-863b1397e206.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 |
|---|
| 64980-418-12 | 64980041812 | 120 TABLET in 1 BOTTLE (64980-418-12) | 120 tablet | 2019-02-25 | 0000-00-00 | No | No | Current |