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NDC 00115-5522-03 FENOFIBRATE 160 mg/1 Details
FENOFIBRATE 160 mg/1
FENOFIBRATE is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals of New York LLC. The primary component is FENOFIBRATE.
MedlinePlus Drug Summary
Fenofibrate is used with a low-fat diet, exercise, and sometimes with other medications to reduce the amounts of fatty substances such as cholesterol and triglycerides in the blood and to increase the amount of HDL (high-density lipoprotein; a type of fatty substance that decreases the risk of heart disease) in the blood. Build-up of cholesterol and fats along the walls of the arteries (a process known as atherosclerosis) decreases the blood flow and, therefore, the oxygen supply to the heart, brain, and other parts of the body. This increases the risk of heart disease, angina (chest pain), strokes, and heart attacks. Although fenofibrate decreases the levels of fatty substances in the blood, it has not been shown to decrease the risk of heart attacks or strokes. Fenofibrate is in a class of medications called antilipemic agents. It works by speeding the natural processes that remove cholesterol from the body.
Related Packages: 00115-5522-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fenofibrate
Product Information
| NDC | 00115-5522 |
|---|---|
| Product ID | 0115-5522_71bb776c-1208-4049-bba2-0f9eb1ea4efe |
| Associated GPIs | 39200025000325 |
| GCN Sequence Number | 044915 |
| GCN Sequence Number Description | fenofibrate TABLET 160 MG ORAL |
| HIC3 | M4E |
| HIC3 Description | LIPOTROPICS |
| GCN | 12595 |
| HICL Sequence Number | 006552 |
| HICL Sequence Number Description | FENOFIBRATE |
| Brand/Generic | Generic |
| Proprietary Name | FENOFIBRATE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | FENOFIBRATE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 160 |
| Active Ingredient Units | mg/1 |
| Substance Name | FENOFIBRATE |
| Labeler Name | Amneal Pharmaceuticals of New York LLC |
| Pharmaceutical Class | Peroxisome Proliferator Receptor alpha Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA076509 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 00115-5522-03 (00115552203)
| NDC Package Code | 0115-5522-03 |
|---|---|
| Billing NDC | 00115552203 |
| Package | 1000 TABLET in 1 BOTTLE (0115-5522-03) |
| Marketing Start Date | 2010-02-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |