FENOFIBRATE
- Product NDC
- 71335-2628
- 11-digit product format
- 713352628
- Labeler code
- 71335
- Product ID
- 71335-2628_338d03b2-c34f-6e24-e063-6394a90a3c39
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fenofibrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA217732
- Marketing category
- ANDA
- Marketing start
- 2023-09-07
- Substance
- FENOFIBRATE
- Active strength
- 40 mg/1
- Pharmacologic classes
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71335-2628_338d03b2-c34f-6e24-e063-6394a90a3c39
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- FENOFIBRATE
- Generic name
- fenofibrate
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2023-09-07
- Marketing category
- ANDA
- Application number
- ANDA217732
- Pharmacologic classes
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| FENOFIBRATE | 40 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 749802, 749804 |
| Spl Set Id | 338d03b2-c34e-6e24-e063-6394a90a3c39 |
| Manufacturer Name | Bryant Ranch Prepack |
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 |
|---|
| 71335-2628-1 | 71335262801 | 90 TABLET in 1 BOTTLE (71335-2628-1) | 90 tablet | 2025-04-14 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| FENOFIBRATE | Bryant Ranch Prepack | 2025-04-24 | HUMAN PRESCRIPTION DRUG LABEL | 1 |