FENOFIBRATE
- Product NDC
- 71335-1756
- 11-digit product format
- 713351756
- Labeler code
- 71335
- Product ID
- 71335-1756_e4d10350-019b-430a-a9c7-0719b1bc65b6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FENOFIBRATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA213864
- Marketing category
- ANDA
- Marketing start
- 2020-09-10
- Substance
- FENOFIBRATE
- Active strength
- 160 mg/1
- Pharmacologic classes
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71335-1756_e4d10350-019b-430a-a9c7-0719b1bc65b6
- SPL ID
- e4d10350-019b-430a-a9c7-0719b1bc65b6
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- FENOFIBRATE
- Generic name
- FENOFIBRATE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2020-09-10
- Marketing category
- ANDA
- Application number
- ANDA213864
- Pharmacologic classes
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| FENOFIBRATE | 160 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 349287 |
| Spl Set Id | d34f9fa3-39ae-4b8e-8f29-0d5c655c50b5 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-1756-1 | 30 TABLET in 1 BOTTLE (71335-1756-1) | 2021-12-20 | No |
| 71335-1756-2 | 90 TABLET in 1 BOTTLE (71335-1756-2) | 2021-12-20 | No |
| 71335-1756-3 | 60 TABLET in 1 BOTTLE (71335-1756-3) | 2021-12-20 | No |
| 71335-1756-4 | 28 TABLET in 1 BOTTLE (71335-1756-4) | 2021-12-20 | No |
| 71335-1756-5 | 100 TABLET in 1 BOTTLE (71335-1756-5) | 2021-12-20 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| U202363UOS | FENOFIBRATE | 49562-28-9 | FENOFIBRATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-1756-1 | 71335175601 | 30 TABLET in 1 BOTTLE (71335-1756-1) | 30 tablet | 2021-12-20 | No | No | Historical |
| 71335-1756-2 | 71335175602 | 90 TABLET in 1 BOTTLE (71335-1756-2) | 90 tablet | 2021-12-20 | No | No | Historical |
| 71335-1756-3 | 71335175603 | 60 TABLET in 1 BOTTLE (71335-1756-3) | 60 tablet | 2021-12-20 | No | No | Historical |
| 71335-1756-4 | 71335175604 | 28 TABLET in 1 BOTTLE (71335-1756-4) | 28 tablet | 2021-12-20 | No | No | Historical |
| 71335-1756-5 | 71335175605 | 100 TABLET in 1 BOTTLE (71335-1756-5) | 100 tablet | 2021-12-20 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| FENOFIBRATE | Bryant Ranch Prepack | 2023-03-31 | HUMAN PRESCRIPTION DRUG LABEL | 101 |