Fenofibrate
- Product NDC
- 69367-254
- 11-digit product format
- 693670254
- Labeler code
- 69367
- Product ID
- 69367-254_9baabd62-d372-4764-b9d5-76e09e15d82b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Westminster Pharmaceuticals, LLC
- Application
- ANDA207803
- Marketing category
- ANDA
- Marketing start
- 2020-04-23
- Substance
- FENOFIBRATE
- Active strength
- 160 mg/1
- Pharmacologic classes
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 | 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 |
|---|
| 69367-254-05 | Fenofibrate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 7 |
| 69367-254-09 | Fenofibrate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69367-254 | FENOFIBRATE TABLET, FILM COATED [WESTMINSTER PHARMACEUTICALS, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240209_a97ebf51-4f68-4426-9958-5c59f91b1d47.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 |
|---|
| 69367-254-05 | 69367025405 | 500 TABLET, FILM COATED in 1 BOTTLE (69367-254-05) | 2020-04-23 | 2026-09-01 | No | No | Current |
| 69367-254-09 | 69367025409 | 90 TABLET, FILM COATED in 1 BOTTLE (69367-254-09) | 2020-04-23 | 0000-00-00 | No | No | Current |