Fenofibrate
- Product NDC
- 50090-7208
- 11-digit product format
- 500907208
- Labeler code
- 50090
- Product ID
- 50090-7208_571604dd-0db9-4c20-a4fa-0553fccb93a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA216798
- Marketing category
- ANDA
- Marketing start
- 2022-09-27
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-7208-0 | Fenofibrate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 50090-7208-1 | Fenofibrate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-7208 | FENOFIBRATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 2 | Current NDC, 2 package rows | 20240808_d26e21bf-6c54-437d-81fe-07220e450561.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7208-0 | 50090720800 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-7208-0) | 2024-08-05 | No | No | Current |
| 50090-7208-1 | 50090720801 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7208-1) | 2024-08-05 | No | No | Current |