Sildenafil Citrate Tablet
Product Images NDC 76420-613

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Sildenafil Citrate (NDC 76420-613). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

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

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Figure-1 (Figure 1)

A scatter plot chart showing the fold change and 90% confidence interval of AUC and Cmax for various interacting drugs relative to Sildenafil alone. The chart lists drugs on the vertical axis and fold change values on the horizontal axis, with recommendations on dose adjustments or coadministration guidance alongside each drug.*

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Figure-2 (Figure 2)

A dot plot chart showing fold change and 90% confidence intervals for pharmacokinetic parameters (AUC and Cmax) of sildenafil citrate when coadministered with various interacting drugs. The x-axis represents change relative to the interacting drug alone. Recommendations regarding dose adjustment are provided alongside each drug interaction.*

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Figure-5 (Figure 5)

A Kaplan-Meier survival curve chart comparing the percentage without a clinically worsening event over days from randomization between Sildenafil and Placebo groups. The x-axis represents days from randomization, and the y-axis represents the percentage without a clinically worsening event, showing higher survival in the Sildenafil group.*

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Figure-6 (Figure 6)

A bar graph showing the percent change in VO2peak across different treatment groups: Placebo, Low Dose, Medium Dose, High Dose, and Combined Doses. Each group includes sample size (n) with error bars indicating variability in the data.*

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4 (Figure 7)

A line graph showing change from baseline (in meters) over weeks 4, 8, and 12 of study for sildenafil citrate dosed at 20 mg, 40 mg, and 80 mg three times daily, compared to placebo. The y-axis represents change from baseline distance, with data points and error bars indicating variability for each treatment group over time.*

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5 (Figure 8)

A forest plot showing placebo-corrected changes in 6-minute walk distance (meters) for Sildenafil 20 mg TID across various subgroups including baseline walk distance, etiology of pulmonary arterial hypertension (PAH), functional capacity class, gender, age, mean pulmonary arterial pressure (PAP), and pulmonary vascular resistance index (PVRI). Each subgroup displays sample sizes and confidence intervals for the change in walk distance compared to placebo.*

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Table 6 (Table 6)

A data table titled 'Hazard Ratios for Overall Survival, Assessed in the Proportional Hazards Model - Intent To Treat Population' comparing sildenafil citrate tablet doses of 5 mg, 20 mg, and 80 mg. It presents patient follow-up years, number and percentages of deaths on and off treatment, and hazard ratio estimates with 99.7% confidence intervals for survival analysis relative to different sildenafil doses.*

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Table 7 (Table 7)

A data table titled 'Table 7. Hazard Ratios for Time to First Event of Clinical Worsening – Intent To Treat Population' comparing clinical worsening events in patients treated with Sildenafil at doses of 5 mg, 20 mg, and 80 mg. It presents patient follow-up years, number of patients with clinical worsening, and percentages for specific events like disease progression, hospitalization for pulmonary arterial hypertension, and death. The table also shows hazard ratio estimates with confidence intervals and p-values for dose comparisons.*

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Image Description (Label)

Packaging labels for Sildenafil Tablets, USP 20 mg by Enovachem Pharmaceuticals, showing multiple NDCs (76420-613-30, 76420-613-60, 76420-613-90) and quantities of 30, 60, and 90 tablets respectively. Labels indicate the product is manufactured for Torrent Pharma Inc., with descriptions of white to off-white round film-coated tablets. The labels include barcodes, QR codes, and storage instructions.*

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1 (Str 02)

Chemical structure diagram of the active ingredient Sildenafil Citrate, showing its molecular composition and arrangement of atoms.*

* 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.