Fenofibrate
- Product NDC
- 62332-555
- 11-digit product format
- 623320555
- Labeler code
- 62332
- Product ID
- 62332-555_ffa16afa-35e9-4845-a0e4-f8b290bd5da4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA209660
- Marketing category
- ANDA
- Marketing start
- 2019-08-01
- Substance
- FENOFIBRATE
- Active strength
- 160 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 | 160 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 |
|---|
| 62332-555-90 | Fenofibrate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 5 |
| 62332-555-91 | Fenofibrate | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-555 | FENOFIBRATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20211117_2985c70d-e85d-483e-8d36-7a4b8454b038.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 |
|---|
| 62332-555-90 | 62332055590 | 90 TABLET, FILM COATED in 1 BOTTLE (62332-555-90) | 2019-08-01 | 0000-00-00 | No | No | Current |
| 62332-555-91 | 62332055591 | 1000 TABLET, FILM COATED in 1 BOTTLE (62332-555-91) | 2019-08-01 | 0000-00-00 | No | No | Current |