FENOFIBRATE
- Product NDC
- 68788-7816
- 11-digit product format
- 687887816
- Labeler code
- 68788
- Product ID
- 68788-7816_9c3e35cf-cced-481b-8649-186d9be6b440
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FENOFIBRATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA213864
- Marketing category
- ANDA
- Marketing start
- 2020-11-06
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-7816-3 | FENOFIBRATE | 30 in 1 BOTTLE | TABLET | 30 | | 7 |
| 68788-7816-9 | FENOFIBRATE | 60 in 1 BOTTLE | TABLET | 60 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7816 | FENOFIBRATE TABLET [PREFERRED PHARMACEUTICALS INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250514_e573b3f1-5a4c-4a19-9f0f-ee797b379a08.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-7816-3 | 68788781603 | 30 TABLET in 1 BOTTLE (68788-7816-3) | 30 tablet | 2020-11-06 | 0000-00-00 | No | No | Current |
| 68788-7816-9 | 68788781609 | 60 TABLET in 1 BOTTLE (68788-7816-9) | 60 tablet | 2020-11-06 | 0000-00-00 | No | No | Current |