FENOFIBRATE
- Product NDC
- 46708-361
- 11-digit product format
- 467080361
- Labeler code
- 46708
- Product ID
- 46708-361_6d6a19bf-2b8a-411a-bd8e-94ae6fadd31f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FENOFIBRATE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA210476
- Marketing category
- ANDA
- Marketing start
- 2019-08-09
- Substance
- FENOFIBRATE
- Active strength
- 145 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 | 145 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 |
|---|
| 46708-361-30 | FENOFIBRATE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 46708-361-71 | FENOFIBRATE | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 2 |
| 46708-361-90 | FENOFIBRATE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-361 | FENOFIBRATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 2 | Current NDC, Legacy NDC, 3 package rows | 20230129_ddafb483-bae5-49bf-845d-67c29e6dc12d.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 |
|---|
| 46708-361-30 | 46708036130 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-361-30) | 2019-08-09 | 0000-00-00 | No | No | Current |
| 46708-361-71 | 46708036171 | 500 TABLET, FILM COATED in 1 BOTTLE (46708-361-71) | 2019-08-09 | 0000-00-00 | No | No | Current |
| 46708-361-90 | 46708036190 | 90 TABLET, FILM COATED in 1 BOTTLE (46708-361-90) | 2019-08-09 | 0000-00-00 | No | No | Current |