fenofibrate
- Product NDC
- 42385-950
- 11-digit product format
- 423850950
- Labeler code
- 42385
- Product ID
- 42385-950_f0dd74ce-5a8e-07b1-e053-2a95a90af387
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fenofibrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Laurus Labs Limited
- Application
- ANDA211122
- Marketing category
- ANDA
- Marketing start
- 2020-03-18
- Substance
- FENOFIBRATE
- Active strength
- 48 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 | 48 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 477560, 477562 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42385-950-11 | fenofibrate | 1000 in 1 BOTTLE | TABLET | 1000 | | 3 |
| 42385-950-30 | fenofibrate | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 42385-950-90 | fenofibrate | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42385-950 | FENOFIBRATE (FENOFIBRATE) TABLET [LAURUS LABS LIMITED] | 3 | Current NDC, Legacy NDC, 3 package rows | 20221229_0da6d56e-1ed6-437d-b88d-16b014d1889a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42385-950-11 | 42385095011 | 1000 TABLET in 1 BOTTLE (42385-950-11) | 1000 tablet | 2020-03-18 | 0000-00-00 | No | No | Current |
| 42385-950-30 | 42385095030 | 30 TABLET in 1 BOTTLE (42385-950-30) | 30 tablet | 2020-03-18 | 0000-00-00 | No | No | Current |
| 42385-950-90 | 42385095090 | 90 TABLET in 1 BOTTLE (42385-950-90) | 90 tablet | 2020-03-18 | 0000-00-00 | No | No | Current |