FENOFIBRATE
- Product NDC
- 71335-0891
- 11-digit product format
- 713350891
- Labeler code
- 71335
- Product ID
- 71335-0891_ee881909-c759-4817-a79b-a498e22c4eb8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FENOFIBRATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA208709
- Marketing category
- ANDA
- Marketing start
- 2016-12-15
- Substance
- FENOFIBRATE
- Active strength
- 48 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
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FENOFIBRATE | 48 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 477562 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-0891-1 | FENOFIBRATE | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 71335-0891-2 | FENOFIBRATE | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
| 71335-0891-3 | FENOFIBRATE | 28 in 1 BOTTLE | TABLET | 28 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-0891 | FENOFIBRATE TABLET [BRYANT RANCH PREPACK] | 5 | Current NDC, Legacy NDC, 3 package rows | 20231122_b11f1c74-23da-4273-b504-0a2ca22c4b5a.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 |
|---|
| 71335-0891-1 | 71335089101 | 30 TABLET in 1 BOTTLE (71335-0891-1) | 30 tablet | 2021-04-08 | 0000-00-00 | No | No | Current |
| 71335-0891-2 | 71335089102 | 90 TABLET in 1 BOTTLE (71335-0891-2) | 90 tablet | 2018-07-02 | 0000-00-00 | No | No | Current |
| 71335-0891-3 | 71335089103 | 28 TABLET in 1 BOTTLE (71335-0891-3) | 28 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |