Fenofibrate
- Product NDC
- 48433-040
- 11-digit product format
- 484330040
- Labeler code
- 48433
- Product ID
- 48433-040_4d75e7d7-4d17-6a1e-e063-6294a90a72a6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fenofibrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Safecor Health, LLC
- Application
- ANDA202856
- Marketing category
- ANDA
- Marketing start
- 2026-03-17
- Substance
- FENOFIBRATE
- Active strength
- 145 mg/1
- Pharmacologic classes
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fenofibrate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FENOFIBRATE | 145 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 477560, 477562 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 48433-040-01 | Fenofibrate | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 2 |
| 48433-040-20 | Fenofibrate | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 48433-040-01 | 48433004001 | 1 in 1 BLISTER PACK | | | | | Historical |
| 48433-040-20 | 48433004020 | 100 BLISTER PACK in 1 CARTON (48433-040-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-040-01) | 100 blister pack | 2026-03-17 | No | No | Current |