SPL Set ID: 26634bf1-c6d8-4d48-9a4e-845c47df07f8

1 drug(s) with this SPL Set ID

Open DailyMed details

Valacyclovir VALACYCLOVIR
500 mg Tablet
SUN PHARMACEUTICAL INDUSTRIES, INC. FDA Rx Only

Valacyclovir hydrochloride, USP is the hydrochloride salt of the L ‑valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each film-coated tablet contains 556.2 mg or 1.112 grams of valacyclovir hydrochloride, USP (hydrous) equivalent to 500 mg or 1 gram valacyclovir, respectively, and the inactive ingredients crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 6000, polysorbate 80, povidone, and titanium dioxide. The chemical name of valacyclovir hydrochloride is L -valine, 2-[(2-amino-1,6-dihydro-6-oxo-9 H -purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula: Valacyclovir hydrochloride, USP (hydrous) is a white to off‑white powder with the molecular formula C 13 H 20 N 6 O 4 •HCl and a molecular weight of 360.80. Valacyclovir hydrochloride, USP (hydrous) is soluble in water and insoluble in dichloromethane, the maximum solubility in water at 25° C is 174 mg/mL. The pk a s for valacyclovir hydrochloride are 1.90, 7.47, and 9.43. Meets USP Dissolution Test 2. Valacyclovir Structural formula

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