FENOFIBRATE
- Product NDC
- 82619-101
- 11-digit product format
- 826190101
- Labeler code
- 82619
- Product ID
- 82619-101_40b943ae-a94c-308c-e063-6294a90a6413
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fenofibrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Creekwood Pharmaceuticals LLC
- Application
- ANDA217732
- Marketing category
- ANDA
- Marketing start
- 2023-09-07
- Substance
- FENOFIBRATE
- Active strength
- 40 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 | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 749802, 749804 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82619-101-01 | FENOFIBRATE | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82619-101 | FENOFIBRATE TABLET [CREEKWOOD PHARMACEUTICALS LLC] | 2 | Current NDC, 1 package rows | 20241016_65d8aefc-7ec2-4f62-9254-5f0070c58ac2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82619-101-01 | 82619010101 | 90 TABLET in 1 BOTTLE (82619-101-01) | 90 tablet | 2023-09-20 | No | No | Current |