Sildenafil Tablet, Film Coated
Product Images NDC 13668-185

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 13668-185). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Torrent Pharmaceuticals Limited, 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

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A line graph depicting estimated cumulative mortality rate (%) over time in years for three dosage groups labeled High dose, Medium dose, and Low dose. The x-axis represents time in years from 0 to 5, and the y-axis shows cumulative mortality rate from 0 to 25%. The graph includes a table indicating the number of subjects at risk at various time points for each dose group.*

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Chemical structure of Sildenafil showing its molecular arrangement, including heterocyclic rings and functional groups consistent with the active pharmaceutical ingredient in the Sildenafil product.*

FDA Label Image

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A chart showing fold changes and 90% confidence intervals for area under the curve (AUC) and maximum concentration (Cmax) values of sildenafil when administered with various interacting drugs, including Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral Contraceptives, Ritonavir, and Saquinavir. The x-axis represents change relative to sildenafil alone, with a vertical reference line at 1. Recommendations for dose adjustment or coadministration accompany each drug comparison.*

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A chart showing drug interaction effects with sildenafil, listing various interacting drugs on the vertical axis, including Acenocoumarol, Aspirin, Atorvastatin, Bosentan, Doxazosin (three variants), Ethinyloestradiol, Levonorgestrel, Phenprocoumon, Ritonavir, Saquinavir, and Tolbutamide. The horizontal axis displays fold change relative to the interacting drug alone, ranging from 0.5 to 2.0. Data points with 90% confidence intervals indicate changes in parameters such as AUC, Cmax, INR, and bleeding time. Recommendations alongside the chart advise no dose adjustment for most drugs, except coadministration of ritonavir is not recommended.*

FDA Label Image

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A line graph showing change from baseline in meters on the y-axis over the course of a study at weeks 4, 8, and 12 on the x-axis. The graph compares four groups: Placebo, Sildenafil 20 mg TID, Sildenafil 40 mg TID, and Sildenafil 80 mg TID, with error bars representing variability at each time point.*

FDA Label Image

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A forest plot chart illustrating placebo-corrected change in 6-minute walk distance (meters) for Sildenafil 20 mg TID across various subgroups, including baseline walk distance, etiology, PH functional capacity class, gender, age, mean PAP, and PVRI. The chart displays sample sizes, confidence intervals, and effect estimates for each subgroup comparison.*

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Kaplan-Meier plot depicting the percentage of patients without clinical worsening of PAS over time in days from randomization in Study 2. The graph compares two groups: Placebo and Sildenafil, showing a higher percentage without worsening over time for the Sildenafil group.*

FDA Label Image

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A line chart titled 'Mean Change from Baseline in Six Minute Walk (meters) by Visit to Week 12 – ITT Population Sildenafil Protocol A1481244' showing mean change from baseline in meters on the y-axis and week of study on the x-axis (Weeks 4, 8, 12). The chart compares three Sildenafil dosages: 1 mg TID, 5 mg TID, and 20 mg TID, with each line including error bars representing the standard error at each visit.*

FDA Label Image

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FDA Label Image

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Label for Sildenafil Tablets, USP 20 mg, film-coated oral tablets. The package contains 30 tablets and is labeled for prescription use only. Manufactured by Torrent Pharmaceuticals Limited. Storage instructions and dosage references are included on the label along with the product NDC 13668-185-30.*

* 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.