Source: FDA, National Drug Code (US) Revision Year: 2020
Diovan HCT (valsartan and hydrochlorothiazide, USP) is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic.
Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)- N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is:
Valsartan 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-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.
Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is:
Diovan HCT tablets are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg, and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.
| Dosage Forms and Strengths |
|---|
|
80/12.5 mg tablets, imprinted CG/HGH (Side 1/Side 2). 160/12.5 mg tablets, imprinted CG/HHH. 160/25 mg tablets, imprinted NVR/HXH. 320/12.5 mg tablets, imprinted NVR/HIL. 320/25 mg tablets, imprinted NVR/CTI. |
| How Supplied |
|---|
|
Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg, and 320/25 mg. Strengths are available as follows. 80/12.5 mg Tablet: Light orange, ovaloid, with slightly convex faces debossed CG on 1 side and HGH on the other side. Bottles of 90 – NDC 0078-0314-34 160/12.5 mg Tablet: Dark red, ovaloid, with slightly convex faces debossed CG on 1 side and HHH on the other side. Bottles of 90 – NDC 0078-0315-34 160/25 mg Tablet: Brown orange, ovaloid, with slightly convex faces debossed NVR on 1 side and HXH on the other side. Bottles of 90 – NDC 0078-0383-34 320/12.5 mg Tablet: Pink, ovaloid, with beveled edge, debossed NVR on 1 side and HIL on the other side. Bottles of 90 – NDC 0078-0471-34 320/25 mg Tablet: Yellow, ovaloid, with beveled edge, debossed NVR on 1 side and CTI on the other side. Bottles of 90 – NDC 0078-0472-34 |
| Drug | Countries | |
|---|---|---|
| DIOVAN HCT | Brazil, Canada, Ecuador, United States |
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