Label: FENOFIBRATE tablet, film coated

  • NDC Code(s): 35561-249-10, 35561-249-13, 35561-250-10, 35561-250-13
  • Packager: AustarPharma, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 23, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets for ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia - Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 General Considerations - Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets, and should continue this diet during treatment with fenofibrate ...
  • 3 DOSAGE FORMS AND STRENGTHS
    48 mg yellow, film coated, oval tablets, debossed “V3650” on one side and plain on the reverse side. 145 mg white, film coated, modified capsule shaped tablets, debossed “V3651” on one side and ...
  • 4 CONTRAINDICATIONS
    Fenofibrate tablets are contraindicated in: patients with severe renal impairment, including those receiving dialysis - [see - Clinical Pharmacology (12.3)] . patients with ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Mortality and Coronary Heart Disease Morbidity - The effect of fenofibrate on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been established. The ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are described below and elsewhere in the labeling: • Mortality and coronary heart disease morbidity [see - Warnings and Precautions (5.1) ...
  • 7 DRUG INTERACTIONS
    7.1 Coumarin Anticoagulants - Potentiation of coumarin-type anticoagulant effects has been observed with prolongation of the PT/INR. Caution should be exercised when coumarin anticoagulants are ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Limited available data with fenofibrate use in pregnant women are insufficient to determine a drug associated risk of major birth defects, miscarriage or adverse ...
  • 10 OVERDOSAGE
    There is no specific treatment for overdose with fenofibrate. General supportive care of the patient is indicated, including monitoring of vital signs and observation of clinical status, should an ...
  • 11 DESCRIPTION
    Fenofibrate tablets, USP, are a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The active moiety of fenofibrate is fenofibric acid. The pharmacological effects of fenofibric acid in both animals and humans have been extensively studied through ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis and Mutagenesis and Impairment of Fertility - Two dietary carcinogenicity studies have been conducted in rats with fenofibrate. In the first 24-month study, Wistar rats were ...
  • 14 CLINICAL STUDIES
    14.1 Primary Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia - The effects of fenofibrate at a dose equivalent to 145 mg fenofibrate tablets per day were ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Fenofibrate Tablets, USP are available in two strengths: 48 mg - Yellow, film coated, oval tablets, debossed “V3650” on one side and plain on the reverse side, available in bottles of 30 (NDC ...
  • 17 PATIENT COUNSELING INFORMATION
    Patients should be advised: of the potential benefits and risks of fenofibrate tablets. not to use fenofibrate tablets if there is a known hypersensitivity to fenofibrate or fenofibric acid. of ...
  • SPL UNCLASSIFIED SECTION
    Manufactured by - AustarPharma, LLC - Edison, NJ 08837 - Revised: 08/2024 - LBL373
  • PRINCIPAL DISPLAY PANEL - 48 mg Container Label 30 Count
    NDC 35561-249-10 - Fenofibrate Tablets, USP - 48 mg - Rx only - 30 Tablets
  • PRINCIPAL DISPLAY PANEL - 48 mg Container Label 500 Count
    NDC 35561-249-13 - Fenofibrate Tablets, USP - 48 mg - Rx only - 500 Tablets
  • PRINCIPAL DISPLAY PANEL - 145 mg Container Label 30 Count
    NDC 35561-250-10 - Fenofibrate Tablets, USP - 145 mg - Rx only - 30 Tablets
  • PRINCIPAL DISPLAY PANEL - 145 mg Container Label 500 Count
    NDC 35561-250-13 - Fenofibrate Tablets, USP - 145 mg - Rx only - 500 Tablets
  • INGREDIENTS AND APPEARANCE
    Product Information