Source: FDA, National Drug Code (US) Revision Year: 2023
Ezetimibe, USP is a dietary cholesterol absorption inhibitor. 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, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe, USP has a melting point of about 163°C and is stable at ambient temperature. Ezetimibe, USP is available as a tablet for oral administration containing 10 mg of ezetimibe and the following inactive ingredients: croscarmellose sodium, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate.
| Dosage Forms and Strengths |
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10-mg tablets are white to off-white, capsule-shaped tablets debossed with “713” on one side and plain on the other side. |
| How Supplied |
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Ezetimibe tablets, USP 10 mg, are white to off white, capsule-shaped tablets debossed with “713” on one side and plain on the other side. They are supplied as follows: NDC 0591-3713-30 bottles of 30 Manufactured In India By: Watson Pharma Private Limited, Verna, Salcette Goa 403 722 INDIA Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054 |
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