Fenofibrate
- Product NDC
- 62332-350
- 11-digit product format
- 623320350
- Labeler code
- 62332
- Product ID
- 62332-350_1b98883d-5552-4efa-9201-da42ea253aae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA213252
- Marketing category
- ANDA
- Marketing start
- 2020-01-23
- Substance
- FENOFIBRATE
- Active strength
- 54 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 | 54 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 349287, 351133 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62332-350-30 | Fenofibrate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 62332-350-71 | Fenofibrate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 5 |
| 62332-350-90 | Fenofibrate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-350 | FENOFIBRATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 3 package rows | 20210414_1e56492f-e2b1-4a07-b697-b59b3a0ac05e.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 |
|---|
| 62332-350-30 | 62332035030 | 30 TABLET, FILM COATED in 1 BOTTLE (62332-350-30) | 2020-01-23 | 0000-00-00 | No | No | Current |
| 62332-350-71 | 62332035071 | 500 TABLET, FILM COATED in 1 BOTTLE (62332-350-71) | 2020-01-23 | 0000-00-00 | No | No | Current |
| 62332-350-90 | 62332035090 | 90 TABLET, FILM COATED in 1 BOTTLE (62332-350-90) | 2020-01-23 | 0000-00-00 | No | No | Current |