SPL Set ID: 3aff1f5e-d92b-686b-e063-6294a90a2995
1 drug(s) with this SPL Set ID
Valacyclovir hydrochloride is the hydrochloride salt of the L -valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains 556.0 mg or 1.112 grams of valacyclovir hydrochloride USP equivalent to 500 mg or 1 gm of valacyclovir, respectively, and the inactive ingredients crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide. In addition to this 500 mg contains FD&C blue #2/ indigo carmine aluminum lake. The chemical name of valacyclovir hydrochloride is L -valine2-[(2-amino-1,6-dihydro-6-oxo-9 H -purin-9-yl)methoxy]ethyl ester hydrochloride monohydrate. It has the following structural formula: Valacyclovir hydrochloride USP (monohydrate) is a white or almost white powder with the molecular formula C 13 H 23 N 6 O 5 Cl and a molecular weight of 378.81. Valacyclovir hydrochloride USP is freely soluble in water and practically insoluble in 1-octanol. The pka for valacyclovir hydrochloride is 5.95. FDA approved dissolution test specifications differ from USP. Structure