Fenofibrate
- Product NDC
- 50090-7208
- 11-digit product format
- 500907208
- Labeler code
- 50090
- Product ID
- 50090-7208_571604dd-0db9-4c20-a4fa-0553fccb93a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- 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 |
|---|
| 50090-7208-0 | 50090720800 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-7208-0) | 2024-08-05 | No | No | Historical |
| 50090-7208-1 | 50090720801 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7208-1) | 2024-08-05 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fenofibrate | A-S Medication Solutions | 2025-10-16 | Human Prescription Drug Label | 4 |
| Fenofibrate | A-S Medication Solutions | 2024-08-07 | Human Prescription Drug Label | 2 |