FENOFIBRATE
- Product NDC
- 62332-360
- 11-digit product format
- 623320360
- Labeler code
- 62332
- Product ID
- 62332-360_69d8eb8b-074c-4209-8bbd-ac35b1364d15
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FENOFIBRATE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA210476
- Marketing category
- ANDA
- Marketing start
- 2019-08-09
- 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 |
|---|
| 62332-360-30 | FENOFIBRATE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 11 |
| 62332-360-71 | FENOFIBRATE | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 11 |
| 62332-360-90 | FENOFIBRATE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-360 | FENOFIBRATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.] | 10 | Current NDC, Legacy NDC, 3 package rows | 20220924_5c579378-e00e-4802-b9d3-c062cf8bd9f4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62332-360-30 | 62332036030 | 30 TABLET, FILM COATED in 1 BOTTLE (62332-360-30) | 2019-08-09 | 0000-00-00 | No | No | Current |
| 62332-360-71 | 62332036071 | 500 TABLET, FILM COATED in 1 BOTTLE (62332-360-71) | 2019-08-09 | 0000-00-00 | No | No | Current |
| 62332-360-90 | 62332036090 | 90 TABLET, FILM COATED in 1 BOTTLE (62332-360-90) | 2019-08-09 | 0000-00-00 | No | No | Current |