Fenofibrate
- Product NDC
- 69238-1263
- 11-digit product format
- 692381263
- Labeler code
- 69238
- Product ID
- 69238-1263_83cbfdb7-7c9b-437a-95da-c0a800e7cb60
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA209950
- Marketing category
- ANDA
- Marketing start
- 2018-03-23
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fenofibrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FENOFIBRATE | 160 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 |
|---|
| 69238-1263-9 | Fenofibrate | 90 in 1 BOTTLE | TABLET | 90 | | 21 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-1263 | FENOFIBRATE TABLET [AMNEAL PHARMACEUTICALS NY LLC] | 21 | Current NDC, Legacy NDC, 1 package rows | 20231231_7e79d495-5d59-485e-b3c2-7c31ba044948.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 |
|---|
| 69238-1263-9 | 69238126309 | 90 TABLET in 1 BOTTLE (69238-1263-9) | 90 tablet | 2018-03-23 | 0000-00-00 | No | No | Current |