Abiraterone
- Product NDC
- 68001-673
- 11-digit product format
- 680010673
- Labeler code
- 68001
- Product ID
- 68001-673_4dc25344-d257-6634-e063-6394a90a2f40
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Abiraterone Acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- BluePoint Laboratories
- Application
- ANDA210686
- Marketing category
- ANDA
- Marketing start
- 2025-10-16
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Abiraterone
- Listing expiration
- 2027-12-31
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 |
|---|
| 68001-673-06 | Abiraterone | 60 in 1 BOTTLE | TABLET | 60 | | 7 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68001-673-06 | 68001067306 | 60 TABLET in 1 BOTTLE (68001-673-06) | 60 tablet | 2025-10-16 | No | No | Current |