Fenofibrate
- Product NDC
- 82009-060
- 11-digit product format
- 820090060
- Labeler code
- 82009
- Product ID
- 82009-060_483b124e-3ea2-42d6-a1a8-8617df9932de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- QUALLENT PHARMACEUTICALS HEALTH LLC
- Application
- ANDA205118
- Marketing category
- ANDA
- Marketing start
- 2022-11-18
- Substance
- FENOFIBRATE
- Active strength
- 145 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 | 145 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 477560 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82009-060-90 | Fenofibrate | 90 in 1 BOTTLE | TABLET, COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82009-060 | FENOFIBRATE TABLET, COATED [QUALLENT PHARMACEUTICALS HEALTH LLC] | 1 | Current NDC, Legacy NDC, 1 package rows | 20221122_215a5000-9f89-47d9-b2d5-94e13f5e1767.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 |
|---|
| 82009-060-90 | 82009006090 | 90 TABLET, COATED in 1 BOTTLE (82009-060-90) | 2022-11-18 | 0000-00-00 | No | No | Current |