Abiraterone Acetate
- Product NDC
- 60219-1165
- 11-digit product format
- 602191165
- Labeler code
- 60219
- Product ID
- 60219-1165_7f57b4d0-9c5f-4714-830b-c7736c3d8b2d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Abiraterone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA208327
- Marketing category
- ANDA
- Marketing start
- 2023-04-28
- 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, 1918042 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60219-1165-7 | 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 |
|---|
| 60219-1165 | ABIRATERONE ACETATE (ABIRATERONE) TABLET ABIRATERONE ACETATE (ABIRATERONE) TABLET [AMNEAL PHARMACEUTICALS NY LLC] | 2 | Current NDC, 1 package rows | 20240420_6fda6b92-59ed-4180-af68-94052a5e82cf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60219-1165-7 | 60219116507 | 120 TABLET in 1 BOTTLE (60219-1165-7) | 120 tablet | 2023-04-28 | No | No | Current |