VYTORIN Tablet Ref.[50754] Active ingredients: Ezetimibe Simvastatin

Source: FDA, National Drug Code (US)  Revision Year: 2022 

Product description

VYTORIN contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin, an HMG-CoA reductase inhibitor.

The chemical name of ezetimibe is 1-(4-fluorophenyl)3==®==[3-(4-fluorophenyl)-3(S)-hydroxypropyl]4(S)(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3 and its molecular weight is 409.4.

Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water.

Its structural formula is:

Simvastatin, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S,4S),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57.

Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol.

Its structural formula is:

VYTORIN is available for oral use as tablets containing 10 mg of ezetimibe, and 10 mg of simvastatin (VYTORIN 10/10), 20 mg of simvastatin (VYTORIN 10/20), 40 mg of simvastatin (VYTORIN 10/40), or 80 mg of simvastatin (VYTORIN 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole NF, citric acid monohydrate USP, croscarmellose sodium NF, hypromellose USP, lactose monohydrate NF, magnesium stearate NF, microcrystalline cellulose NF, and propyl gallate NF.

Dosage Forms and Strengths
  • VYTORIN 10/10, (ezetimibe 10 mg and simvastatin 10 mg tablets) are white to off-white capsule-shaped tablets with code “311” on one side.
  • VYTORIN 10/20, (ezetimibe 10 mg and simvastatin 20 mg tablets) are white to off-white capsule-shaped tablets with code “312” on one side.
  • VYTORIN 10/40, (ezetimibe 10 mg and simvastatin 40 mg tablets) are white to off-white capsule-shaped tablets with code “313” on one side.
  • VYTORIN 10/80, (ezetimibe 10 mg and simvastatin 80 mg tablets) are white to off-white capsule-shaped tablets with code “315” on one side.
How Supplied

VYTORIN 10/10 are white to off-white capsule-shaped tablets with code “311” on one
side.

They are supplied as follows:

NDC 78206-174-01 bottles of 30
NDC 78206-174-02 bottles of 90

VYTORIN 10/20 are white to off-white capsule-shaped tablets with code “312” on one
side.

They are supplied as follows:

NDC 78206-175-01 bottles of 30
NDC 78206-175-02 bottles of 90

VYTORIN 10/40 are white to off-white capsule-shaped tablets with code “313” on one side.

They are supplied as follows:

NDC 78206-176-01 bottles of 30
NDC 78206-176-02 bottles of 90

VYTORIN 10/80 are white to off-white capsule-shaped tablets with code “315” on one
side.

They are supplied as follows:

NDC 78206-177-01 bottles of 30
NDC 78206-177-02 bottles of 90

Distributed by: Organon LLC, a subsidiary of ORGANON & Co., Jersey City, NJ 07302, USA

Drugs

Drug Countries
VYTORIN Australia, Brazil, Germany, Ecuador, Spain, Hong Kong, Italy, Mexico, Singapore, United States

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.