SPL Set ID: e6d11cd6-7204-4031-a6c5-8f6a33568ab4

1 drug(s) with this SPL Set ID

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IRBESARTAN AND HYDROCHLOROTHIAZIDE IRBESARTAN AND HYDROCHLOROTHIAZIDE
HISUN PHARMACEUTICALS USA INC. FDA Rx Only

Irbesartan and hydrochlorothiazide tablets USP are a combination of an angiotensin II receptor antagonist (AT 1 subtype), irbesartan, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[ p -( o -1 H -tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its molecular formula is C 25 H 28 N 6 O, and its structural formula is: Irbesartan, USP 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. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide1,1­ dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is: Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution. Irbesartan and hydrochlorothiazide tablets, USP are available for oral administration in film-coated tablets containing either 150 mg or 300 mg of irbesartan, USP combined with 12.5 mg of hydrochlorothiazide, USP. All dosage strengths contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, magnesium stearate, colloidal silicon dioxide, ferric oxide red, ferric oxide yellow, polyethylene glycol, titanium dioxide. Chemical Structure Chemical Structure

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