Fenofibrate
- Product NDC
- 60505-3121
- 11-digit product format
- 605053121
- Labeler code
- 60505
- Product ID
- 60505-3121_81d94e71-5260-d81d-f3b9-070ec3c0743a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA202252
- Marketing category
- ANDA
- Marketing start
- 2013-07-26
- Substance
- FENOFIBRATE
- Active strength
- 130 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 | 130 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 483425, 483427 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60505-3121-1 | Fenofibrate | 100 in 1 BOTTLE | CAPSULE | 100 | | 14 |
| 60505-3121-3 | Fenofibrate | 30 in 1 BOTTLE | CAPSULE | 30 | | 14 |
| 60505-3121-5 | Fenofibrate | 500 in 1 BOTTLE | CAPSULE | 500 | | 14 |
| 60505-3121-9 | Fenofibrate | 90 in 1 BOTTLE | CAPSULE | 90 | | 14 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-3121 | FENOFIBRATE CAPSULE [APOTEX CORP.] | 12 | Current NDC, Legacy NDC, 4 package rows | 20240927_68024459-987a-9cf4-f539-4959093bc9f0.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 |
|---|
| 60505-3121-1 | 60505312101 | 100 CAPSULE in 1 BOTTLE (60505-3121-1) | 100 capsule | 2013-07-26 | 0000-00-00 | No | No | Current |
| 60505-3121-3 | 60505312103 | 30 CAPSULE in 1 BOTTLE (60505-3121-3) | 30 capsule | 2013-07-26 | 0000-00-00 | No | No | Current |
| 60505-3121-5 | 60505312105 | 500 CAPSULE in 1 BOTTLE (60505-3121-5) | 500 capsule | 2013-07-26 | 0000-00-00 | No | No | Current |
| 60505-3121-9 | 60505312109 | 90 CAPSULE in 1 BOTTLE (60505-3121-9) | 90 capsule | 2013-07-26 | 0000-00-00 | No | No | Current |