Fenofibrate
- Product NDC
- 71335-2688
- 11-digit product format
- 713352688
- Labeler code
- 71335
- Product ID
- 71335-2688_594eb16c-1d18-4a19-9bbe-70cfc442b930
- 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
- 145 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 | 145 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 477560 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2688-1 | 71335268801 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2688-1) | 2025-09-18 | No | No | Historical |
| 71335-2688-2 | 71335268802 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2688-2) | 2025-09-18 | No | No | Historical |
| 71335-2688-3 | 71335268803 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-2688-3) | 2025-09-18 | No | No | Historical |