LU B21 Pill — YELLOW OVAL, 13mm — Fenofibrate

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Imprint	LU / B21
Colour	YELLOW
Shape	OVAL
Size	13
Strength	FENOFIBRATE 48 mg
Dosage form	Tablet
Manufacturer	LUPIN LIMITED
NDC	57297-360
Schedule	—
Availability	—
Ingredients	FENOFIBRATE[FENOFIBRIC ACID]

What does this imprint mean?

The imprint "LU B21" is a code stamped or printed on the tablet or capsule by the manufacturer, used to identify the drug, its strength and the maker.

Active ingredient

Fenofibrate

Uses and warnings

No boxed warning. Contraindicated in "severe renal impairment, including those with end-stage renal disease," "active liver disease," "pre-existing gallbladder disease," and known hypersensitivity to fenofibrate or fenofibric acid. Major warnings include risk of "serious drug-induced liver injury, including liver transplantation and death"; "myopathy and rhabdomyolysis," particularly with concomitant statin use or renal impairment; increased serum creatinine; cholelithiasis; pancreatitis; venous thromboembolism; and potentiated anticoagulant effect with coumarin-type drugs requiring dose adjustment and monitoring.

Fenofibrate is indicated as adjunctive therapy to diet to reduce "triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL)" and to reduce elevated "low-density lipoprotein cholesterol (LDL-C)" in adults with primary hyperlipidemia when statin therapy is not appropriate. The label includes an important limitation of use: "Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus."

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