SPL Set ID: 1b72ecfd-a08d-48c5-a853-d3bc9ff882f1

Valsartan and hydrochlorothiazide tablets, USP are a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT 1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N -[p-(o-1 H -Tetrazol-5-ylphenyl)benzyl- N -valeryl- L -valine. Its molecular formula is C 24 H 29 N 5 O 3 , its molecular weight is 435.5, and its structural formula is: Valsartan, USP is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n -butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-Chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its molecular formula is C 7 H 8 ClN 3 O 4 S 2 , its molecular weight is 297.73, and its structural formula is: Valsartan and hydrochlorothiazide tablets are formulated for oral administration to contain valsartan and hydrochlorothiazide 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg and 320 mg/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch (corn), sodium lauryl sulfate, titanium dioxide and triacetin. The 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg and 320 mg/12.5 mg tablets also contain red iron oxide and yellow iron oxide. The 320 mg/25 mg tablet also contains FD&C Blue No. 2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Valsartan Structural Formula Hydrochlorothiazide Structural Formula