SPL Set ID: e7222f81-3e6b-dfe1-379a-83ca350f91a9

Benazepril hydrochloride, USP is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H -1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is Its molecular formula is C 24 H 28 N 2 O 5 ·HCl, and its molecular weight is 460.96 g/mol. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. 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’s chemical name is 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide; its structural formula is Its molecular formula is C 7 H 8 ClN 3 O 4 S 2 , and its molecular weight is 297.74 g/mol. Hydrochlorothiazide is a thiazide diuretic. Benazepril hydrochloride and hydrochlorothiazide tablets, USP are a combination of benazepril hydrochloride, USP and hydrochlorothiazide, USP. The tablets are formulated for oral administration with a combination of 5, 10, or 20 mg of benazepril hydrochloride, USP and 6.25, 12.5, or 25 mg of hydrochlorothiazide, USP. The inactive ingredients of the tablets are black iron oxide (20 mg/12.5 mg), crospovidone, colloidal silicon dioxide, ferric oxide (10 mg/12.5 mg, 20 mg/12.5 mg and 20 mg/25 mg), hypromellose, hydroxypropyl cellulose, microcrystalline cellulose, polyethylene glycol, titanium dioxide and zinc stearate. benazepril-hctz-02 benazepril-hctz-03