COZAAR Film-coated tablet Ref.[10551] Active ingredients: Losartan

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

COZAAR (losartan potassium) is an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt.

Its empirical formula is C22H22ClKN6O, and its structural formula is:

Losartan potassium is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan.

COZAAR is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: microcrystalline cellulose, lactose hydrous, pregelatinized starch, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide.

COZAAR 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. COZAAR 25 mg, COZAAR 50 mg, and COZAAR 100 mg may also contain carnauba wax.

Dosage Forms and Strengths
  • COZAAR, 25 mg, are white, oval, film-coated tablets with code 951 on one side.
  • COZAAR, 50 mg, are white, oval, film-coated tablets with code 952 on one side and scored on the other.
  • COZAAR, 100 mg, are white, teardrop-shaped, film-coated tablets with code 960 on one side.
How Supplied

COZAAR is a white film-coated tablet supplied as follows:

Losartan Shape Engraving (reverse) NDC 0006-xxxx-xx
Bottle/30 Bottle/90
25 mg oval 951 n/a 0951-54
50 mg oval 952 (scored) 0952-31 0952-54
100 mg teardrop 960 0960-31 0960-54

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Drugs

Drug Countries
COZAAR Brazil, Canada, Cyprus, Germany, Ecuador, Spain, Finland, France, Hong Kong, Ireland, Mexico, Netherlands, Poland, Singapore, Turkey, United Kingdom, United States, South Africa

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