NDC 31722-0595-90
Fenofibrate 48 mg/1 TABLET, FILM COATED
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NDC
31722-0595-90
Generic Name
Fenofibrate
Brand Name
Fenofibrate
Strength
48 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Package Size
—
Labeler
Camber Pharmaceuticals, Inc.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Fenofibratetablets are indicated as adjunctive therapy to diet: • to reduce triglyceride (TG) levels in adultswith severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). • to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is notpossible. Limitations of Use • Markedlyelevated levels of serum TG (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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