AVAPRO Film-coated tablet Ref.[10541] Active ingredients: Irbesartan

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

Product description

AVAPRO (irbesartan) is an angiotensin II receptor (AT1 subtype) antagonist.

Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one.

Its empirical formula is C25H28N6O, and the structural formula:

Irbesartan is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water.

AVAPRO is available for oral administration in unscored, film-coated tablets containing 75 mg, 150 mg, or 300 mg of irbesartan. Inactive ingredients include: carnauba wax, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, and titanium dioxide.

Dosage Forms and Strengths

AVAPRO 75 mg is a white to off-white, biconvex oval, film-coated, tablet debossed with a heart on one side and “2871” on the other.

AVAPRO 150 mg is a white to off-white, biconvex oval, film-coated, tablet debossed with a heart on one side and “2872” on the other.

AVAPRO 300 mg is a white to off-white, biconvex oval, film-coated, tablet debossed with a heart on one side and “2873” on the other.

How Supplied

AVAPRO (irbesartan) is available as white to off-white, biconvex oval, film-coated tablets, debossed with a heart shape on one side and a code on the other (see Table below). Unit-of-use bottles contain 30 or 90 film-coated tablets as follows:

 75 mg 150 mg 300 mg
Debossing 2871 2872 2873
Bottle of 30 0024-5851-30 0024-5852-30
Bottle of 90 0024-5850-90

sanofi-aventis U.S. LLC, Bridgewater, NJ 08807
A SANOFI COMPANY

Drugs

Drug Countries
AVAPRO Australia, Japan, United States

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