fenofibrate
- Product NDC
- 68462-580
- 11-digit product format
- 684620580
- Labeler code
- 68462
- Product ID
- 68462-580_6c9e4429-e3c7-4a34-ae48-d4e2a2bdf00f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fenofibrate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA205566
- Marketing category
- ANDA
- Marketing start
- 2017-04-07
- Substance
- FENOFIBRATE
- Active strength
- 67 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 | 67 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 |
|---|
| 68462-580-01 | fenofibrate | 100 in 1 BOTTLE | CAPSULE | 100 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-580 | FENOFIBRATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA] | 12 | Current NDC, Legacy NDC, 1 package rows | 20240104_e7204052-02cf-4b38-835b-d8754c74b2cd.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 |
|---|
| 68462-580-01 | 68462058001 | 100 CAPSULE in 1 BOTTLE (68462-580-01) | 100 capsule | 2017-04-07 | 0000-00-00 | No | No | Current |