Abiraterone Acetate
- Product NDC
- 75907-224
- 11-digit product format
- 759070224
- Labeler code
- 75907
- Product ID
- 75907-224_6c96e35d-9099-e164-0960-353b01420f81
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Abiraterone Acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dr. Reddys Laboratories Inc
- Application
- ANDA208416
- Marketing category
- ANDA
- Marketing start
- 2025-03-17
- 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 |
|---|
| 75907-224-04 | Abiraterone Acetate | 120 in 1 BOTTLE | TABLET | 120 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75907-224 | ABIRATERONE ACETATE TABLET [DR. REDDYS LABORATORIES INC] | 1 | Current NDC, 1 package rows | 20250327_0c91aa38-3b0a-232c-8eb1-55f08e8e6644.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 |
|---|
| 75907-224-04 | 75907022404 | 120 TABLET in 1 BOTTLE (75907-224-04) | 120 tablet | 2025-03-17 | No | No | Current |