Fenofibrate
- Product NDC
- 42291-427
- 11-digit product format
- 422910427
- Labeler code
- 42291
- Product ID
- 42291-427_485d31e4-a2a8-8165-e063-6294a90a14fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA207803
- Marketing category
- ANDA
- Marketing start
- 2023-03-08
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42291-427-50 | Fenofibrate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 2 |
| 42291-427-90 | Fenofibrate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-427 | FENOFIBRATE TABLET, FILM COATED [AVKARE] | 1 | Current NDC, 2 package rows | 20230309_f669f231-98b9-5014-e053-2a95a90a4e4c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42291-427-50 | 42291042750 | 500 TABLET, FILM COATED in 1 BOTTLE (42291-427-50) | 2023-03-08 | No | No | Current |
| 42291-427-90 | 42291042790 | 90 TABLET, FILM COATED in 1 BOTTLE (42291-427-90) | 2023-03-08 | No | No | Current |