Fenofibrate
- Product NDC
- 59651-575
- 11-digit product format
- 596510575
- Labeler code
- 59651
- Product ID
- 59651-575_728e5bad-086b-492f-9ecc-ad9562e5e25e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA216798
- Marketing category
- ANDA
- Marketing start
- 2022-09-27
- Substance
- FENOFIBRATE
- Active strength
- 54 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 | 54 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 |
|---|
| 59651-575-90 | Fenofibrate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-575 | FENOFIBRATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | Current NDC, Legacy NDC, 1 package rows | 20250214_a7cfa38f-b4db-40d3-8821-3f7c85e2727e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59651-575-90 | 59651057590 | 90 TABLET, FILM COATED in 1 BOTTLE (59651-575-90) | 2022-09-27 | 0000-00-00 | No | No | Current |