Fenofibrate
- Product NDC
- 50268-338
- 11-digit product format
- 502680338
- Labeler code
- 50268
- Product ID
- 50268-338_47e54612-62a7-c6dd-e063-6294a90a8ff7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA090856
- Marketing category
- ANDA
- Marketing start
- 2022-09-22
- Substance
- FENOFIBRATE
- Active strength
- 48 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 | 48 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 477562 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50268-338-11 | Fenofibrate | 1 in 1 BLISTER PACK | TABLET | 1 | | 3 |
| 50268-338-12 | Fenofibrate | 20 in 1 BOX | TABLET | 20 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50268-338 | FENOFIBRATE TABLET [AVPAK] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240110_e949c068-bc7d-3038-e053-2a95a90aee00.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 |
|---|
| 50268-338-11 | 50268033811 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 50268-338-12 | 50268033812 | 20 BLISTER PACK in 1 BOX (50268-338-12) / 1 TABLET in 1 BLISTER PACK (50268-338-11) | 20 blister pack | 2022-09-22 | 0000-00-00 | No | No | Current |