Fenofibrate
- Product NDC
- 43975-306
- 11-digit product format
- 439750306
- Labeler code
- 43975
- Product ID
- 43975-306_379ca6d7-14ee-4c36-a271-325d231a2fba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA209504
- Marketing category
- ANDA
- Marketing start
- 2018-05-01
- Substance
- FENOFIBRATE
- Active strength
- 200 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 | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 200311, 310288, 310289 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43975-306-10 | Fenofibrate | 100 in 1 BOTTLE | CAPSULE | 100 | | 7 |
| 43975-306-50 | Fenofibrate | 500 in 1 BOTTLE | CAPSULE | 500 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43975-306 | FENOFIBRATE CAPSULE [ANI PHARMACEUTICALS, INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20220922_c740f57c-cac5-4526-a5a9-aaab65b1caf6.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 |
|---|
| 43975-306-10 | 43975030610 | 100 CAPSULE in 1 BOTTLE (43975-306-10) | 100 capsule | 2018-05-01 | 0000-00-00 | No | No | Current |
| 43975-306-50 | 43975030650 | 500 CAPSULE in 1 BOTTLE (43975-306-50) | 500 capsule | 2018-05-01 | 0000-00-00 | No | No | Current |