Source: FDA, National Drug Code (US) Revision Year: 2019
Valtrex (valacyclovir hydrochloride) is the hydrochloride salt of the L‑valyl ester of the antiviral drug acyclovir.
VALTREX tablets are for oral administration. Each tablet contains 556.2 mg or 1.112 grams of valacyclovir hydrochloride equivalent to 500 mg or 1 gram of valacyclovir, respectively, and the inactive ingredients carnauba wax, colloidal silicon dioxide, crospovidone, FD&C Blue No. 2 Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide. The blue, film‑coated tablets are printed with edible white ink.
The chemical name of valacyclovir hydrochloride is L - valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride.
It has the following structural formula:
Valacyclovir hydrochloride is a white to off-white powder with the molecular formula C13H20N6O4•HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pkas for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.
| Dosage Forms and Strengths |
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Tablets:
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| How Supplied |
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VALTREX tablets (blue, film‑coated, capsule‑shaped tablets printed with “VALTREX 500 mg”) containing 556.2 mg of valacyclovir hydrochloride equivalent to 500 mg valacyclovir. Bottle of 30 (NDC 0173-0933-08). Bottle of 90 (NDC 0173-0933-10). Unit dose pack of 100 (NDC 0173-0933-56). VALTREX tablets (blue, film‑coated, capsule‑shaped tablets, with a partial scorebar on both sides, printed with “VALTREX 1 gram”) containing 1.112 grams of valacyclovir hydrochloride equivalent to 1 gram of valacyclovir. Bottle of 30 (NDC 0173-0565-04). Bottle of 90 (NDC 0173-0565-10). Distributed by: GlaxoSmithKline, Research Triangle Park, NC 27709 |
| Drug | Countries | |
|---|---|---|
| VALTREX | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, Hong Kong, Ireland, Israel, Japan, Lithuania, Nigeria, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
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