Abiraterone Acetate
- Product NDC
- 43598-468
- 11-digit product format
- 435980468
- Labeler code
- 43598
- Product ID
- 43598-468_5e7f1aec-5727-4e71-1a05-55e8eef89e0a
- 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
- 2023-09-11
- Substance
- ABIRATERONE ACETATE
- Active strength
- 500 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 | 500 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 |
|---|
| 43598-468-38 | Abiraterone Acetate | 6 in 1 CARTON | TABLET | 6 | | 18 |
| 43598-468-60 | Abiraterone Acetate | 60 in 1 BOTTLE | TABLET | 60 | | 18 |
| 43598-468-79 | Abiraterone Acetate | 10 in 1 BLISTER PACK | TABLET | 10 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-468 | ABIRATERONE ACETATE TABLET [DR. REDDYS LABORATORIES INC] | 18 | Current NDC, 3 package rows | 20230911_7eda0d98-c2ba-c117-b757-1f566292e789.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 |
|---|
| 43598-468-38 | 43598046838 | 6 BLISTER PACK in 1 CARTON (43598-468-38) / 10 TABLET in 1 BLISTER PACK (43598-468-79) | 6 blister pack | 2023-09-11 | No | No | Current |
| 43598-468-60 | 43598046860 | 60 TABLET in 1 BOTTLE (43598-468-60) | 60 tablet | 2023-09-11 | No | No | Current |
| 43598-468-79 | 43598046879 | 10 in 1 BLISTER PACK | | | | | Historical |