Fenofibrate
- Product NDC
- 71335-2016
- 11-digit product format
- 713352016
- Labeler code
- 71335
- Product ID
- 71335-2016_72a68150-905a-4ecd-a439-1cb925684873
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fenofibrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202856
- Marketing category
- ANDA
- Marketing start
- 2013-05-14
- Substance
- FENOFIBRATE
- Active strength
- 145 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 | 145 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 477560 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-2016-1 | Fenofibrate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 101 |
| 71335-2016-2 | Fenofibrate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 101 |
| 71335-2016-3 | Fenofibrate | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 101 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-2016 | FENOFIBRATE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 101 | Current NDC, Legacy NDC, 3 package rows | 20231118_42b1daf6-1f0e-4464-b160-7c10c492a570.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 |
|---|
| 71335-2016-1 | 71335201601 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2016-1) | 2022-02-10 | 0000-00-00 | No | No | Current |
| 71335-2016-2 | 71335201602 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2016-2) | 2022-02-10 | 0000-00-00 | No | No | Current |
| 71335-2016-3 | 71335201603 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-2016-3) | 2022-02-10 | 0000-00-00 | No | No | Current |