Fenofibrate
- Product NDC
- 51655-433
- 11-digit product format
- 516550433
- Labeler code
- 51655
- Product ID
- 51655-433_490ec676-81a8-6ba1-e063-6394a90a5039
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fenofibrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA200884
- Marketing category
- ANDA
- Marketing start
- 2020-09-17
- Substance
- FENOFIBRATE
- Active strength
- 145 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 | 145 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 477560 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-433-52 | Fenofibrate | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-433 | FENOFIBRATE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC] | 1 | Current NDC, 1 package rows | 20230328_f2f46239-951d-fc0e-e053-2995a90ae979.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-433-52 | 51655043352 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-433-52) | 2020-09-17 | No | No | Current |