Fenofibrate
- Product NDC
- 33342-348
- 11-digit product format
- 333420348
- Labeler code
- 33342
- Product ID
- 33342-348_a504c42a-b629-4a21-a716-084962266b48
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA210379
- Marketing category
- ANDA
- Marketing start
- 2026-01-21
- Substance
- FENOFIBRATE
- Active strength
- 160 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 | 160 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 349287, 351133 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33342-348-10 | Fenofibrate | 90 in 1 CONTAINER | TABLET | 90 | | 1 |
| 33342-348-12 | Fenofibrate | 10 in 1 BLISTER PACK | TABLET | 10 | | 1 |
| 33342-348-12 | Fenofibrate | 10 in 1 CARTON | TABLET | 10 | | 1 |
| 33342-348-15 | Fenofibrate | 500 in 1 CONTAINER | TABLET | 500 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 33342-348-10 | 33342034810 | 90 TABLET in 1 CONTAINER (33342-348-10) | 90 tablet | 2026-01-21 | No | No | Current |
| 33342-348-12 | 33342034812 | 10 BLISTER PACK in 1 CARTON (33342-348-12) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2026-01-21 | No | No | Current |
| 33342-348-15 | 33342034815 | 500 TABLET in 1 CONTAINER (33342-348-15) | 500 tablet | 2026-01-21 | No | No | Current |