Fenofibrate
- Product NDC
- 33342-339
- 11-digit product format
- 333420339
- Labeler code
- 33342
- Product ID
- 33342-339_ab7aad70-2879-4260-831e-cbfbe8be73b2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA210248
- Marketing category
- ANDA
- Marketing start
- 2024-11-13
- Substance
- FENOFIBRATE
- Active strength
- 48 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 |
|---|
| 33342-339-07 | 33342033907 | 30 TABLET in 1 BOTTLE (33342-339-07) | 30 tablet | 2024-11-13 | No | No | Historical |
| 33342-339-10 | 33342033910 | 90 TABLET in 1 BOTTLE (33342-339-10) | 90 tablet | 2024-11-13 | No | No | Historical |
| 33342-339-12 | 33342033912 | 10 BLISTER PACK in 1 CARTON (33342-339-12) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2024-11-13 | No | No | Historical |
| 33342-339-15 | 33342033915 | 500 TABLET in 1 BOTTLE (33342-339-15) | 500 tablet | 2024-11-13 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fenofibrate | Macleods Pharmaceuticals Limited | 2025-07-09 | Human Prescription Drug Label | 2 |