Valacyclovir Tablet, Film Coated
Product Images NDC 61919-066

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Valacyclovir (NDC 61919-066). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Direct Rx, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Image Description (Label)

Label for Valacyclovir 500 mg film-coated tablets containing 60 tablets. Generic for Valtrex, each tablet contains Valacyclovir Hydrochloride USP equivalent to Valacyclovir 500 mg. Packaged and distributed by Direct Rx in Alpharetta, GA. Includes lot number, discard date 06/18, storage instructions, and warnings to keep out of reach of children.*

FDA Label Image

Image Description (Molecule)

Chemical structure of valacyclovir hydrochloride shown along with a brief description of its physical properties, molecular formula (C13H20N6O4·HCl), molecular weight (360.80), solubility, and pKa values.*

FDA Label Image

Image Description (Table2)

A data table detailing dosage regimens of Valacyclovir for various conditions such as cold sores, genital herpes, immunocompetent patients, HIV-infected patients, and herpes zoster. It shows dosage adjustments based on creatinine clearance levels, with specified doses and frequency for normal renal function and reductions for impaired kidney function.*

FDA Label Image

Image Description (Table3)

A data table presenting laboratory abnormalities comparing valacyclovir hydrochloride to placebo in clinical studies for herpes zoster and genital herpes treatment. It lists percentages of hemoglobin, white blood cells, platelet count, AST (SGOT), and serum creatinine abnormalities under different dosing regimens and sample sizes.*

FDA Label Image

Image Description (Table4)

A data table presenting results for genital herpes suppression comparing Valacyclovir hydrochloride 1 gram once daily, Valacyclovir hydrochloride 500 mg once daily, and placebo groups with sample sizes of 269, 266, and 134 respectively. The table shows percentages of various outcomes or measurements across these groups.*

FDA Label Image

Image Description (Table5)

A table presenting pharmacokinetic data of a drug at various doses (100 mg to 1,000 mg). It summarizes single-dose and multiple-dose administration results, showing Cmax (maximum concentration) and AUC (area under curve) values with standard deviations in mcg/mL and hr•mcg/mL respectively. Some data points are marked as ND (not detected).*

FDA Label Image

Image Description (Table6)

A data table presenting pharmacokinetic parameters (AUC and C-max) of Valacyclovir in pediatric patients receiving 20 mg/kg oral suspension across three age groups (<2 years, 2-<6 years, 6-<12 years) and adults receiving a 1 gram solid dose of Valacyclovir Hydrochloride. Values include means with standard deviations for each parameter and group.*

FDA Label Image

Image Description (Table7)

A data table comparing the outcomes of Valacyclovir Hydrochloride 1 gram once daily, Oral acyclovir 400 mg twice daily, and Placebo over 6 and 12 months. Outcomes include recurrence-free rates, recurrences, and unknown results with corresponding percentages and sample sizes.*

FDA Label Image

Image Description (Table8)

A data table comparing outcomes between Valacyclovir Hydrochloride 500 mg twice daily and placebo groups. It shows percentages of recurrence-free cases, recurrences, and unknown outcomes for each group, with sample sizes of 194 and 99 respectively.*

FDA Label Image

Image Description (Table9)

A table titled 'Percentage of Susceptible Partners Who Acquired HSV-2 Defined by the Primary and Selected Secondary Endpoints.' It compares the outcomes between Valacyclovir (n=743) and Placebo (n=741) groups for symptomatic HSV-2 acquisition, HSV-2 seroconversion, and overall HSV-2 acquisition, presenting counts and percentages for each endpoint.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.