abiraterone acetate
- Product NDC
- 60505-4764
- 11-digit product format
- 605054764
- Labeler code
- 60505
- Product ID
- 60505-4764_0b559376-5181-40da-8b69-461bf4d1238e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Abiraterone acetate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA212462
- Marketing category
- ANDA
- Marketing start
- 2021-07-16
- 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
- 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 | 1918042 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60505-4764-6 | abiraterone acetate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-4764 | ABIRATERONE ACETATE TABLET, FILM COATED [APOTEX CORP.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20231026_9ce9d926-ef3a-4b22-a703-f49c18eb4e3d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60505-4764-6 | 60505476406 | 60 TABLET, FILM COATED in 1 BOTTLE (60505-4764-6) | 2021-07-16 | 0000-00-00 | No | No | Current |