Fenofibrate
- Product NDC
- 69097-894
- 11-digit product format
- 690970894
- Labeler code
- 69097
- Product ID
- 69097-894_06d917b6-6950-4b49-b830-a1fa0b8ac0b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fenofibrate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Cipla USA Inc.,
- Application
- ANDA207378
- Marketing category
- ANDA
- Marketing start
- 2017-03-30
- Substance
- FENOFIBRATE
- Active strength
- 67 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 | 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 |
|---|
| 69097-894-02 | Fenofibrate | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 6 |
| 69097-894-07 | Fenofibrate | 100 in 1 BOTTLE, PLASTIC | CAPSULE | 100 | | 6 |
| 69097-894-15 | Fenofibrate | 1000 in 1 BOTTLE, PLASTIC | CAPSULE | 1000 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69097-894 | FENOFIBRATE CAPSULE [CIPLA USA INC.,] | 6 | Current NDC, Legacy NDC, 3 package rows | 20230121_07d47c02-ab29-4ba9-aea0-96ffbd70c0ef.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 |
|---|
| 69097-894-02 | 69097089402 | 30 CAPSULE in 1 BOTTLE, PLASTIC (69097-894-02) | 30 capsule | 2017-03-30 | 0000-00-00 | No | No | Current |
| 69097-894-07 | 69097089407 | 100 CAPSULE in 1 BOTTLE, PLASTIC (69097-894-07) | 100 capsule | 2017-03-30 | 0000-00-00 | No | No | Current |
| 69097-894-15 | 69097089415 | 1000 CAPSULE in 1 BOTTLE, PLASTIC (69097-894-15) | 1000 capsule | 2017-03-30 | 0000-00-00 | No | No | Current |