Fenofibrate
- Product NDC
- 0378-4391
- 11-digit product format
- 003784391
- Labeler code
- 0378
- Product ID
- 0378-4391_beac0c72-4b03-4b72-9568-db8a22571fe0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fenofibrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA204475
- Marketing category
- ANDA
- Marketing start
- 2016-06-23
- Substance
- FENOFIBRATE
- Active strength
- 120 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 | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 749802, 749804 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-4391-77 | Fenofibrate | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-4391 | FENOFIBRATE TABLET [MYLAN PHARMACEUTICALS INC.] | 9 | Current NDC, Legacy NDC, 1 package rows | 20240208_5b67f389-55e8-466b-82bd-5ea992f630aa.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 |
|---|
| 0378-4391-77 | 00378439177 | 90 TABLET in 1 BOTTLE, PLASTIC (0378-4391-77) | 90 tablet | 2016-06-23 | 0000-00-00 | No | No | Current |