Fenofibrate
- Product NDC
- 68788-4006
- 11-digit product format
- 687884006
- Labeler code
- 68788
- Product ID
- 68788-4006_2e6711e9-782d-46bd-9447-6612fe7d0fe7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA090856
- Marketing category
- ANDA
- Marketing start
- 2025-08-08
- 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-4006-1 | 68788400601 | 100 TABLET in 1 BOTTLE (68788-4006-1) | 100 tablet | 2025-08-08 | No | No | Historical |
| 68788-4006-3 | 68788400603 | 30 TABLET in 1 BOTTLE (68788-4006-3) | 30 tablet | 2025-08-08 | No | No | Historical |
| 68788-4006-6 | 68788400606 | 60 TABLET in 1 BOTTLE (68788-4006-6) | 60 tablet | 2025-08-08 | No | No | Historical |
| 68788-4006-9 | 68788400609 | 90 TABLET in 1 BOTTLE (68788-4006-9) | 90 tablet | 2025-08-08 | No | No | Historical |