Fenofibrate
- Product NDC
- 42858-454
- 11-digit product format
- 428580454
- Labeler code
- 42858
- Product ID
- 42858-454_2ee176e8-44de-4206-a71a-d0cbacdc0a81
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rhodes Pharmaceuticals L.P.
- Application
- ANDA076433
- Marketing category
- ANDA
- Marketing start
- 2017-06-01
- Substance
- FENOFIBRATE
- Active strength
- 54 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
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FENOFIBRATE | 54 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 |
|---|
| 42858-454-45 | Fenofibrate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42858-454 | FENOFIBRATE TABLET, FILM COATED [RHODES PHARMACEUTICALS L.P.] | 8 | Current NDC, Legacy NDC, 1 package rows | 20230309_5e7b79ab-9df0-4bbf-b7a4-a44aec203555.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 |
|---|
| 42858-454-45 | 42858045445 | 90 TABLET, FILM COATED in 1 BOTTLE (42858-454-45) | 2017-06-01 | 0000-00-00 | No | No | Current |