Fenofibrate
- Product NDC
- 69097-459
- 11-digit product format
- 690970459
- Labeler code
- 69097
- Product ID
- 69097-459_ee5bc824-e200-4a5f-9374-bf71e665aeaa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FENOFIBRATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA208709
- Marketing category
- ANDA
- Marketing start
- 2016-12-15
- Substance
- FENOFIBRATE
- Active strength
- 48 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 | 48 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 477560, 477562 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69097-459-02 | Fenofibrate | 30 in 1 BOTTLE | TABLET | 30 | | 11 |
| 69097-459-05 | Fenofibrate | 90 in 1 BOTTLE | TABLET | 90 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69097-459 | FENOFIBRATE TABLET [CIPLA USA INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20221228_f8f09ab1-74db-4123-b85a-6337dc2582a0.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 |
|---|
| 69097-459-02 | 69097045902 | 30 TABLET in 1 BOTTLE (69097-459-02) | 30 tablet | 2016-12-15 | 0000-00-00 | No | No | Current |
| 69097-459-05 | 69097045905 | 90 TABLET in 1 BOTTLE (69097-459-05) | 90 tablet | 2016-12-15 | 0000-00-00 | No | No | Current |