FENOFIBRATE
- Product NDC
- 72789-410
- 11-digit product format
- 727890410
- Labeler code
- 72789
- Product ID
- 72789-410_324713a3-9b23-55ea-e063-6394a90abaab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FENOFIBRATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA076509
- Marketing category
- ANDA
- Marketing start
- 2022-06-22
- 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 |
|---|
| 72789-410-30 | FENOFIBRATE | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-410 | FENOFIBRATE TABLET [PD-RX PHARMACEUTICALS, INC.] | 5 | Current NDC, 1 package rows | 20250410_35ba17d9-0dd7-4f15-8f74-be5fd15f1917.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 |
|---|
| 72789-410-30 | 72789041030 | 30 TABLET in 1 BOTTLE, PLASTIC (72789-410-30) | 30 tablet | 2024-06-05 | No | No | Historical |