FENOFIBRATE
- Product NDC
- 70518-4326
- 11-digit product format
- 705184326
- Labeler code
- 70518
- Product ID
- 70518-4326_402f17d7-61cf-529d-e063-6394a90a4bd7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FENOFIBRATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA076509
- Marketing category
- ANDA
- Marketing start
- 2025-04-10
- Substance
- FENOFIBRATE
- Active strength
- 160 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 | 160 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 349287 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4326-0 | FENOFIBRATE | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4326 | FENOFIBRATE TABLET [REMEDYREPACK INC.] | 1 | Current NDC, 1 package rows | 20250418_882ee82a-3c56-4173-af42-68c3aadc8aa7.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 |
|---|
| 70518-4326-0 | 70518432600 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-4326-0) | 90 tablet | 2025-04-10 | No | No | Historical |