Fenofibrate
- Product NDC
- 13668-438
- 11-digit product format
- 136680438
- Labeler code
- 13668
- Product ID
- 13668-438_6602b2c6-0128-4d70-8581-9abee72f152e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA210782
- Marketing category
- ANDA
- Marketing start
- 2018-07-01
- Substance
- FENOFIBRATE
- Active strength
- 200 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 | 200 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 |
|---|
| 13668-438-01 | Fenofibrate | 100 in 1 BOTTLE | CAPSULE | 100 | | 13 |
| 13668-438-05 | Fenofibrate | 500 in 1 BOTTLE | CAPSULE | 500 | | 13 |
| 13668-438-90 | Fenofibrate | 90 in 1 BOTTLE | CAPSULE | 90 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13668-438 | FENOFIBRATE CAPSULE [TORRENT PHARMACEUTICALS LIMITED] | 13 | Current NDC, Legacy NDC, 3 package rows | 20241212_573ffb90-61a7-4b2d-b191-13de6c01d19e.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 |
|---|
| 13668-438-01 | 13668043801 | 100 CAPSULE in 1 BOTTLE (13668-438-01) | 100 capsule | 2018-07-01 | 0000-00-00 | No | No | Current |
| 13668-438-05 | 13668043805 | 500 CAPSULE in 1 BOTTLE (13668-438-05) | 500 capsule | 2018-07-01 | 0000-00-00 | No | No | Current |
| 13668-438-74 | 13668043874 | 10 BLISTER PACK in 1 CARTON (13668-438-74) > 10 CAPSULE in 1 BLISTER PACK (13668-438-71) | 10 blister pack | 2021-06-03 | 0000-00-00 | No | No | Current |
| 13668-438-90 | 13668043890 | 90 CAPSULE in 1 BOTTLE (13668-438-90) | 90 capsule | 2018-07-01 | 0000-00-00 | No | No | Current |