Abiraterone
- Product NDC
- 69539-049
- 11-digit product format
- 695390049
- Labeler code
- 69539
- Product ID
- 69539-049_2c63b39b-45a2-48d0-a2c4-c39b2e5e4861
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Abiraterone acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- MSN LABORATORIES PRIVATE LIMITED
- Application
- ANDA210686
- Marketing category
- ANDA
- Marketing start
- 2019-07-10
- Marketing end
- 0000-00-00
- Substance
- ABIRATERONE ACETATE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Cytochrome P450 17A1 Inhibitors [MoA],Cytochrome P450 17A1 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69539-049 | ABIRATERONE (ABIRATERONE ACETATE) TABLET ABIRATERONE (ABIRATERONE ACETATE) TABLET, FILM COATED [MSN LABORATORIES PRIVATE LIMITED] | 10 | Legacy NDC | 20240525_0a84f388-a8b4-4065-93a6-1c663c99d265.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69539-049-92 | 69539004992 | 120 TABLET in 1 BOTTLE (69539-049-92) | 120 tablet | 2019-07-10 | 0000-00-00 | No | No | Current |