Sildenafil
Product Images NDC 50436-5517

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 50436-5517). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Unit Dose Services, 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

Figure 6: Kaplan-meier Plot Of Mortality By Sildenafil Dose (Image 01)

A Kaplan-Meier plot depicting estimated cumulative mortality rate (%) over time (years) for three dose groups: High Dose, Medium Dose, and Low Dose. The y-axis shows mortality rate rising up to 25%, and the x-axis spans 0 to 5 years. The plot includes stepwise lines for each dose group with patient numbers at risk listed above the graph at multiple time points.*

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Sildenafil Citrate Structural Formula (Image 02)

Chemical structure of Sildenafil showing its molecular composition including nitrogen, oxygen, carbon, and sulfur atoms arranged in rings and chains consistent with the known structure of the active ingredient Sildenafil.*

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Figure 9. Change From Baseline In 6 Minute Walk Distance (meters) At Weeks 4, 8, And 12 In Study 1: Mean (95% Confidence Interval) (Image 05)

A line chart depicting change from baseline in meters on the y-axis across weeks 4, 8, and 12 on the x-axis. It shows comparative results for four groups: Placebo, Sildenafil 20mg TID, Sildenafil 40mg TID, and Sildenafil 80mg TID. Each data point includes error bars, illustrating variability across the weeks of the study.*

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Figure 10. Placebo-corrected Change From Baseline In 6 Minute Walk Distance (meters) At Week 12 By Study Subpopulation In Study 1: Mean (95% Confidence Interval) (Image 06)

A horizontal forest plot chart depicting placebo-corrected change in 6-minute walk distance (meters) for Sildenafil 20 mg TID across various subgroups, including baseline walk distance, etiology, PH criteria and therapeutic class, gender, age, mean PAP, and PVRI. The chart includes group sizes and confidence intervals represented by horizontal bars and diamond markers.*

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Figure 11. Kaplan-meier Plot Of Time (in Days) To Clinical Worsening Of Pah In Study 2 (Image 07)

A line graph showing the percentage of subjects without a clinically worsening event over days from randomization. Two lines represent groups, one for Placebo and one for Sildenafil, with the Sildenafil group maintaining a higher percentage without events across the 112-day period.*

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Figure 12. Mean Change From Baseline In Six Minute Walk (meters) By Visit To Week 12 – Itt Population Sildenafil Protocol A1481244 (Image 08)

A line plot showing the mean change from baseline in meters on the vertical axis over weeks 4, 8, and 12 on the horizontal axis. It compares three Sildenafil dosage groups: 1 mg TID, 5 mg TID, and 20 mg TID. Each data point includes error bars indicating the standard error for each treatment at each visit.*

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Label Image (Lbl504365517)

Sildenafil 20 mg unit dose packaging label from Unit Dose Services with NDC 50436-5517-1. The label states Rx only and that each foil-coated tablet contains sildenafil citrate. It specifies the package contains three tablets in a pouch, with 200 pouches per case. It includes storage instructions, manufacturing and repackaging information, and a barcode with lot and expiration placeholders.*

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A chart displaying the fold change and 90% confidence intervals for area under the curve (AUC) and maximum concentration (Cmax) of Sildenafil when coadministered with various interacting drugs, including Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral Contraceptives, Ritonavir, and Saquinavir. The chart includes recommendations on dose adjustments or cautions for each drug interaction.*

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A chart showing fold change and 90% confidence intervals for interactions between sildenafil and various drugs. The x-axis represents change relative to the interacting drug alone, with a vertical line at x=1 indicating no change. The chart lists interacting drugs on the vertical axis alongside pharmacokinetic parameters (AUC, Cmax, INR, BT) and provides dosing recommendations, mostly stating no dose adjustment needed, except for ritonavir where coadministration is not recommended.*

* 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.