Fenofibrate
- Product NDC
- 72789-310
- 11-digit product format
- 727890310
- Labeler code
- 72789
- Product ID
- 72789-310_4bbc4809-ec1c-375d-e063-6394a90a1cfc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA201748
- Marketing category
- ANDA
- Marketing start
- 2015-03-02
- Substance
- FENOFIBRATE
- Active strength
- 130 mg/1
- Pharmacologic classes
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fenofibrate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FENOFIBRATE | 130 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 483425 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-310-30 | Fenofibrate | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-310 | FENOFIBRATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 13 | Current NDC, 1 package rows | 20250221_2f5cee5c-ec55-4e9b-9d54-e7f2f052130e.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 |
|---|
| 72789-310-30 | 72789031030 | 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-310-30) | 30 capsule | 2022-03-15 | No | No | Current |