fenofibrate
- Product NDC
- 69315-288
- 11-digit product format
- 693150288
- Labeler code
- 69315
- Product ID
- 69315-288_e13cbb9d-3850-4f6e-8db1-3e7f1fb23f8a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fenofibrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Leading Pharma, LLC
- Application
- ANDA211122
- Marketing category
- ANDA
- Marketing start
- 2022-07-18
- 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, 477562 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69315-288-05 | fenofibrate | 500 in 1 BOTTLE | TABLET | 500 | | 2 |
| 69315-288-09 | fenofibrate | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69315-288 | FENOFIBRATE TABLET [LEADING PHARMA, LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20241207_ca09372a-3c75-47c9-80a3-e08dbe243bb4.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 |
|---|
| 69315-288-05 | 69315028805 | 500 TABLET in 1 BOTTLE (69315-288-05) | 500 tablet | 2022-07-18 | 0000-00-00 | No | No | Current |
| 69315-288-09 | 69315028809 | 90 TABLET in 1 BOTTLE (69315-288-09) | 90 tablet | 2022-07-18 | 0000-00-00 | No | No | Current |