SPL Set ID: cc6c4939-7908-439c-b1b8-6b52e826c7a5

1 drug(s) with this SPL Set ID

Open DailyMed details

Valganciclovir VALGANCICLOVIR
50 mg/ml Liquid
FLORIDA PHARMACEUTICAL PRODUCTS, LLC FDA Rx Only

Valganciclovir for oral solution contains valganciclovir hydrochloride, USP, a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. Valganciclovir is available as a powder for oral solution, which when constituted with water as directed contains 50 mg/mL valganciclovir free base. The inactive ingredients of valganciclovir for oral solution are mannitol, povidone, sodium benzoate, sucralose, tartaric acid, and tutti-frutti flavor. Valganciclovir HCl is a white to off-white powder with freely soluble in water, sparingly soluble in methanol with a molecular formula of C 14 H 22 N 6 O 5 ·HCl and a molecular weight of 390.82. The chemical name for valganciclovir HCl is L-Valine,2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir HCl, USP is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH 7.0. The pKa for valganciclovir HCl is 7.70. The chemical structure of Valganciclovir HCl, is: All doses in this insert are specified in terms of valganciclovir. valgan-spl-structure

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