Fenofibrate
- Product NDC
- 68071-3542
- 11-digit product format
- 680713542
- Labeler code
- 68071
- Product ID
- 68071-3542_2d3fb146-e3be-92bf-e063-6394a90a1b3a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA216798
- Marketing category
- ANDA
- Marketing start
- 2022-09-27
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3542-9 | 68071354209 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-3542-9) | 2023-11-29 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fenofibrate | NuCare Pharmaceuticals,Inc. | 2025-02-03 | HUMAN PRESCRIPTION DRUG LABEL | 2 |