fenofibrate
- Product NDC
- 68071-4991
- 11-digit product format
- 680714991
- Labeler code
- 68071
- Product ID
- 68071-4991_1b3066de-04ac-9ff3-e063-6294a90a7adc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fenofibrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA210138
- Marketing category
- ANDA
- Marketing start
- 2018-07-20
- Substance
- FENOFIBRATE
- Active strength
- 160 mg/1
- Pharmacologic classes
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| U202363UOS | FENOFIBRATE | 49562-28-9 | FENOFIBRATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-4991-9 | 68071499109 | 90 TABLET in 1 BOTTLE (68071-4991-9) | 90 tablet | 2019-07-26 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| fenofibrate | NuCare Pharmaceuticals,Inc. | 2024-06-18 | HUMAN PRESCRIPTION DRUG LABEL | 3 |