Fenofibrate
- Product NDC
- 71335-2654
- 11-digit product format
- 713352654
- Labeler code
- 71335
- Product ID
- 71335-2654_d4158878-3666-47ec-b6f2-680db3dadd9a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA204598
- Marketing category
- ANDA
- Marketing start
- 2016-07-14
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fenofibrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FENOFIBRATE | 48 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 477562 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-2654-1 | Fenofibrate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 71335-2654-2 | Fenofibrate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
| 71335-2654-3 | Fenofibrate | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2654-1 | 71335265401 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2654-1) | 2025-06-20 | No | No | Current |
| 71335-2654-2 | 71335265402 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2654-2) | 2025-06-20 | No | No | Current |
| 71335-2654-3 | 71335265403 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-2654-3) | 2025-06-20 | No | No | Current |