Abiraterone
- Product NDC
- 72789-213
- 11-digit product format
- 727890213
- Labeler code
- 72789
- Product ID
- 72789-213_40ac0f51-34ed-e949-e063-6294a90a2366
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Abiraterone acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA208339
- Marketing category
- ANDA
- Marketing start
- 2018-11-23
- 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
- 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 |
|---|
| 72789-213-98 | Abiraterone | 120 in 1 BOTTLE, PLASTIC | TABLET | 120 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-213 | ABIRATERONE (ABIRATERONE ACETATE) TABLET [PD-RX PHARMACEUTICALS, INC.] | 15 | Current NDC, Legacy NDC, 1 package rows | 20240906_413c645e-074d-4276-b39a-d83521077602.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 |
|---|
| 72789-213-98 | 72789021398 | 120 TABLET in 1 BOTTLE, PLASTIC (72789-213-98) | 120 tablet | 2021-10-11 | 0000-00-00 | No | No | Current |