Abirtega
- Product NDC
- 82249-011
- 11-digit product format
- 822490011
- Labeler code
- 82249
- Product ID
- 82249-011_692d596d-5465-4611-82f7-5d50c37270a2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Abiraterone acetate
- Dosage form
- TABLET
- Route
- ORAL; ORAL
- Labeler
- CivicaScript, LLC
- 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
- Abirtega
- 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, 2702601 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82249-011-12 | Abirtega | 120 in 1 BOTTLE, PLASTIC | TABLET | 120 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82249-011 | ABIRTEGA (ABIRATERONE ACETATE) TABLET [CIVICASCRIPT, LLC] | 2 | Current NDC, 1 package rows | 20250131_2f932015-28b2-4f44-ac04-772e982e13e9.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 |
|---|
| 82249-011-12 | 82249001112 | 120 TABLET in 1 BOTTLE, PLASTIC (82249-011-12) | 120 tablet | 2025-01-17 | No | No | Historical |