Fenofibrate
- Product NDC
- 46708-086
- 11-digit product format
- 467080086
- Labeler code
- 46708
- Product ID
- 46708-086_2e637d10-c15a-48f8-9261-13b3df419c85
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA213842
- Marketing category
- ANDA
- Marketing start
- 2020-10-22
- Substance
- FENOFIBRATE
- Active strength
- 200 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 | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 200311, 310288, 310289 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-086-30 | Fenofibrate | 30 in 1 BOTTLE | CAPSULE | 30 | | 2 |
| 46708-086-31 | Fenofibrate | 100 in 1 BOTTLE | CAPSULE | 100 | | 2 |
| 46708-086-71 | Fenofibrate | 500 in 1 BOTTLE | CAPSULE | 500 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-086 | FENOFIBRATE CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED] | 2 | Current NDC, Legacy NDC, 3 package rows | 20230119_954753e7-c8d4-487c-b2ad-f90dfb758a92.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 |
|---|
| 46708-086-30 | 46708008630 | 30 CAPSULE in 1 BOTTLE (46708-086-30) | 30 capsule | 2020-10-22 | 0000-00-00 | No | No | Current |
| 46708-086-31 | 46708008631 | 100 CAPSULE in 1 BOTTLE (46708-086-31) | 100 capsule | 2020-10-22 | 0000-00-00 | No | No | Current |
| 46708-086-71 | 46708008671 | 500 CAPSULE in 1 BOTTLE (46708-086-71) | 500 capsule | 2020-10-22 | 0000-00-00 | No | No | Current |