Fenofibrate Capsule
NDC 50090-7994

The NDC code 50090-7994 is assigned by the FDA to the product Fenofibrate. This pharmaceutical product is labeled by A-s Medication Solutions and is currently categorized as listed product. The medication is a capsule administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 50090-7994-0. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

Treatment of HypercholesterolemiaFenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below).Treatment of HypertriglyceridemiaFenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia).Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention.Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia2.The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, like thiazide diuretics and beta-blockers, is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet (see WARNINGS and PRECAUTIONS). Fredrickson Classification of HyperlipoproteinemiasLipid ElevationTypeLipoprotein ElevatedMajorMinorI (rare)chylomicronsTG↑↔CIIaLDLC—IIbLDL, VLDLCTGIII (rare)IDLC, TG—IVVLDLTG↑↔CV (rare)Chylomicrons, VLDLTG↑↔C = cholesterol TG = triglyceridesLDL = low density lipoprotein VLDL = very low density lipoproteinIDL = intermediate density lipoproteinThe NCEP Treatment GuidelinesDefinite Athlerosclerotic DiseaseaTwo or More Other Risk FactorsbLDL-Cholesterol mg/dL (mmol/L) Initiation Level GoalNoNo≥ 190 (≥ 4.9)< 160 (< 4.1)NoYes≥ 160 (≥ 4.1)< 130 (< 3.4)YesYes or No≥ 130c  (≥ 3.4)< 100 (< 2.6)a Coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease).b Other risk factors for coronary heart disease (CHD) include: age (males: ≥ 45 years; females: ≥ 55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL-C <35 mg/dL (<0.91mmol/L); and diabetes mellitus. Subtract 1 risk factor if HDL-C is ≥ 60 mg/dL (≥1.6 mmol/L)c In CHD patients with LDL-C levels 100 to 129 mg/dL, the physician should exercise clinical judgment in deciding whether to initiate drug treatment.

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

• FENOFIBRATE 200 mg/1 - An antilipemic agent which reduces both CHOLESTEROL and TRIGLYCERIDES in the blood.

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:

• RxCUI: 310289 - fenofibrate 200 MG Oral Capsule

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

• Peroxisome Proliferator Receptor alpha Agonist - [EPC] (Established Pharmacologic Class)