FENOFIBRATE
- Product NDC
- 0904-7161
- 11-digit product format
- 009047161
- Labeler code
- 0904
- Product ID
- 0904-7161_fd80c625-958e-4895-bdfa-aad99dae8941
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FENOFIBRATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA208709
- Marketing category
- ANDA
- Marketing start
- 2016-12-15
- Substance
- FENOFIBRATE
- Active strength
- 145 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 | 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 |
|---|
| 0904-7161-04 | FENOFIBRATE | 30 in 1 CARTON | TABLET | 30 | | 5 |
| 0904-7161-04 | FENOFIBRATE | 1 in 1 BLISTER PACK | TABLET | 1 | | 5 |
| 0904-7161-61 | FENOFIBRATE | 100 in 1 CARTON | TABLET | 100 | | 5 |
| 0904-7161-61 | FENOFIBRATE | 1 in 1 BLISTER PACK | TABLET | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7161 | FENOFIBRATE TABLET [MAJOR PHARMACEUTICALS] | 3 | Current NDC, Legacy NDC, 4 package rows | 20250207_bbffd586-f63a-4a84-bdfb-3e4a1df6449e.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 |
|---|
| 0904-7161-04 | 00904716104 | 30 BLISTER PACK in 1 CARTON (0904-7161-04) / 1 TABLET in 1 BLISTER PACK | 30 blister pack | 2016-12-15 | 2026-06-30 | No | No | Current |
| 0904-7161-61 | 00904716161 | 100 BLISTER PACK in 1 CARTON (0904-7161-61) / 1 TABLET in 1 BLISTER PACK | 100 blister pack | 2016-12-15 | 0000-00-00 | No | No | Current |