PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg

Rx only
Valacyclovir Tablets, USP
500 mg

11 DESCRIPTION

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 mg or 1.112 grams of valacyclovir hydrochloride USP (hydrous) equivalent to 500 mg or 1 gram of valacyclovir, respectively, and the inactive ingredients crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, 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 or almost white powder with the molecular formula C 13H 20N 6O 4•HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pk as for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.

16 HOW SUPPLIED/STORAGE AND HANDLING

Valacyclovir Tablets USP, 500 mgare blue, film-coated, capsule shaped tablets with “F 82” on one side and plain on the otherside containing 556 mg of valacyclovir hydrochloride equivalent to 500 mg of valacyclovir.

Bottles of 6 NDC 72789-263-06

Bottles of 10 NDC 72789-263-10
Bottles of 14 NDC 72789-263-14

Bottles of 28 NDC 72789-263-28
Bottles of 90 NDC 72789-263-90

Store at20 oto 25 oC (68 oto 77 oF). [See USP Controlled Room Temperature.]

Dispense in a well-closed container as defined in the USP.