abiraterone acetate
- Product NDC
- 72603-111
- 11-digit product format
- 726030111
- Labeler code
- 72603
- Product ID
- 72603-111_843754c5-046d-4b63-b1d4-344fbb7592fb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- abiraterone acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NORTHSTAR RX LLC
- Application
- ANDA209227
- Marketing category
- ANDA
- Marketing start
- 2022-05-19
- 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 acetate
- 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 |
|---|
| 72603-111-01 | abiraterone acetate | 60 in 1 BOTTLE | TABLET | 60 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72603-111 | ABIRATERONE ACETATE TABLET [NORTHSTAR RX LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240103_42d5baa8-aca7-49d8-9c24-9d87b707ec20.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 |
|---|
| 72603-111-01 | 72603011101 | 60 TABLET in 1 BOTTLE (72603-111-01) | 60 tablet | 2022-05-19 | 0000-00-00 | No | No | Current |