Source: FDA, National Drug Code (US) Revision Year: 2021
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 |
| Drug | Countries | |
|---|---|---|
| ZETIA | Brazil, Italy, Japan, United States |
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