Abiraterone Acetate
- Product NDC
- 16714-963
- 11-digit product format
- 167140963
- Labeler code
- 16714
- Product ID
- 16714-963_564a91be-2efd-3ec5-1996-1491749f271e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Abiraterone Acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA208416
- Marketing category
- ANDA
- Marketing start
- 2020-05-19
- 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 |
|---|
| 16714-963-01 | Abiraterone Acetate | 120 in 1 BOTTLE | TABLET | 120 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-963 | ABIRATERONE ACETATE TABLET [NORTHSTAR RX LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20231227_39434b24-bf64-f5c9-fbb6-b0d225099424.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16714-963-01 | 16714096301 | 120 TABLET in 1 BOTTLE (16714-963-01) | 120 tablet | 2020-05-19 | 0000-00-00 | No | No | Current |