ZETIA Tablet Ref.[49667] Active ingredients: Ezetimibe

Source: FDA, National Drug Code (US)  Revision Year: 2021 

Product description

ZETIA (ezetimibe) is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3 (R) -4(S)(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is:

Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. ZETIA is available as a tablet for oral administration containing 10 mg of ezetimibe and the following inactive ingredients: croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate NF, microcrystalline cellulose NF, povidone USP, and sodium lauryl sulfate NF.

Dosage Forms and Strengths

10 mg tablets are white to off-white, capsule-shaped tablets debossed with “414” on one side.

How Supplied

No. 3861 – Tablets ZETIA, 10 mg, are white to off-white, capsule-shaped tablets debossed with “414” on one side. They are supplied as follows:

NDC 66582-414-31 bottles of 30
NDC 66582-414-54 bottles of 90
NDC 66582-414-74 bottles of 500
NDC 66582-414-76 bottles of 5000
NDC 66582-414-28 unit dose packages of 100.

Drugs

Drug Countries
ZETIA Brazil, Italy, Japan, United States

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