Fenofibrate
- Product NDC
- 63304-448
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fenofibrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA200884
- Marketing category
- ANDA
- Substance
- FENOFIBRATE
- Current FDA listing
- Historical FDA.report record
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|
| 63304-448-05 | 500 TABLET, FILM COATED in 1 BOTTLE (63304-448-05) | 2018-06-01 | | No | Current |
| 63304-448-30 | 30 TABLET, FILM COATED in 1 BOTTLE (63304-448-30) | 2018-06-01 | | No | Current |
| 63304-448-90 | 90 TABLET, FILM COATED in 1 BOTTLE (63304-448-90) | 2018-06-01 | | No | Current |
Related DailyMed Labels
| Set ID | Title | Manufacturer | Effective date | Type | Version |
|---|
| 125bbd7e-86a2-4209-90a5-ad353e572d1b | These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablet, for oral use Initial U.S. Approval: 1993 | Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited | 2025-01-29 | HUMAN PRESCRIPTION DRUG LABEL | 12 |