Fenofibrate
- Product NDC
- 42858-134
- 11-digit product format
- 428580134
- Labeler code
- 42858
- Product ID
- 42858-134_ed6ef266-83c1-4183-83a0-a10b76a55e49
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Rhodes Pharmaceuticals LLC
- Application
- ANDA075753
- Marketing category
- ANDA
- Marketing start
- 2017-06-01
- Marketing end
- 2026-07-31
- Substance
- FENOFIBRATE
- Active strength
- 134 mg/1
- Pharmacologic classes
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fenofibrate
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FENOFIBRATE | 134 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 200311, 310288, 310289 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42858-134-01 | Fenofibrate | 100 in 1 BOTTLE | CAPSULE | 100 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42858-134 | FENOFIBRATE CAPSULE [RHODES PHARMACEUTICALS L.P.] | 9 | Current NDC, Legacy NDC, 1 package rows | 20230325_829f5c2e-3329-4644-bccb-267afb678540.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 |
|---|
| 42858-134-01 | 42858013401 | 100 CAPSULE in 1 BOTTLE (42858-134-01) | 100 capsule | 2017-06-01 | 2026-07-31 | No | No | Current |