Fenofibrate capsules is 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). This formulation utilizes a capsule delivery system. Marketed by A-s Medication Solutions, this product is identified by NDC 50090-7994 and is authorized under FDA application ANDA213842.
Identification & Billing
NDC Package Code
50090-7994-0
Package Description
90 CAPSULE in 1 BOTTLE
11-Digit Billing Format
50090799400
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Clinical Specifications
Proprietary Name
Fenofibrate
Non-Proprietary Name
Fenofibrate
Substance Name
Fenofibrate
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Usage Information
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.
Regulatory & Marketing
Labeler Name
A-s Medication Solutions
Product Type
Human Prescription Drug
FDA Application #
ANDA213842
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-22-2020
Listing Expiration
12-31-2027
Hierarchy Structure
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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