FENOFIBRATE
- Product NDC
- 42385-936
- 11-digit product format
- 423850936
- Labeler code
- 42385
- Product ID
- 42385-936_f0dfffd1-9c2c-0cbd-e053-2a95a90a908c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FENOFIBRATE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Laurus Labs Limited
- Application
- ANDA210606
- Marketing category
- ANDA
- Marketing start
- 2020-01-13
- 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, 351133 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42385-936-05 | FENOFIBRATE | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 4 |
| 42385-936-11 | FENOFIBRATE | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 4 |
| 42385-936-30 | FENOFIBRATE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 42385-936-90 | 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 |
|---|
| 42385-936 | FENOFIBRATE (FENOFIBRATE) TABLET, FILM COATED [LAURUS LABS LIMITED] | 4 | Current NDC, Legacy NDC, 4 package rows | 20221229_8e58c13a-8088-4fed-86cc-52530de5aa45.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 |
|---|
| 42385-936-05 | 42385093605 | 500 TABLET, FILM COATED in 1 BOTTLE (42385-936-05) | 2020-01-13 | 0000-00-00 | No | No | Current |
| 42385-936-11 | 42385093611 | 1000 TABLET, FILM COATED in 1 BOTTLE (42385-936-11) | 2020-01-13 | 0000-00-00 | No | No | Current |
| 42385-936-30 | 42385093630 | 30 TABLET, FILM COATED in 1 BOTTLE (42385-936-30) | 2020-01-13 | 0000-00-00 | No | No | Current |
| 42385-936-90 | 42385093690 | 90 TABLET, FILM COATED in 1 BOTTLE (42385-936-90) | 2020-01-13 | 0000-00-00 | No | No | Current |