Sildenafil Citrate
Product Images NDC 50436-0185

11 FDA label images from Unit Dose Services · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Sildenafil Citrate (NDC 50436-0185). 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

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A Kaplan-Meier survival curve chart showing estimated cumulative mortality rates over a 5-year period for three dose groups: high dose, medium dose, and low dose. The x-axis represents time in years, and the y-axis represents mortality rate percentage. The chart includes the number of subjects at risk over time for each dose group.*
FDA Label Image

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Chemical structure of the active ingredient Sildenafil Citrate, showing its molecular formula with various functional groups including a pyrazolopyrimidinone core and a citrate moiety.*
FDA Label Image

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A forest plot chart showing fold change and 90% confidence intervals for the area under the curve (AUC) and maximum concentration (Cmax) of Sildenafil Citrate when coadministered with various interacting drugs. The chart compares these changes to Sildenafil alone (vertical solid line at 1) with recommendations on dose adjustments alongside each drug listed, including Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral Contraceptives, Ritonavir, and Saquinavir.*
FDA Label Image

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A forest plot showing fold change and 90% confidence intervals of drug interaction effects on pharmacokinetic parameters such as AUC and Cmax for Sildenafil Citrate when coadministered with various interacting drugs. The chart includes recommendations on dose adjustment, mostly indicating no dose adjustment is needed, with exceptions noted for ritonavir and saquinavir.*
FDA Label Image

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A line graph depicting change from baseline in meters over weeks of study (Week 4, 8, and 12) for different doses of Sildenafil Citrate (20mg TID, 40mg TID, 80mg TID) compared to placebo. Data points include error bars indicating variability at each time point.*
FDA Label Image

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A forest plot depicting placebo-corrected changes in 6-minute walk distance (meters) for Sildenafil 20 mg TID across various patient subgroups including baseline walk distance, etiology, pulmonary hypertension functional class, gender, age, mean pulmonary artery pressure, and pulmonary vascular resistance index. The data are presented with confidence intervals for each subgroup comparison between placebo and Sildenafil.*
FDA Label Image

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Kaplan-Meier plot illustrating the time in days to clinical worsening of PAS in Study 2, comparing placebo and Sildenafil groups. The x-axis represents days from randomization, while the y-axis shows the percentage without a clinically worsening event. The plot displays survival-like curves for both groups over approximately 112 days.*
FDA Label Image

Figure 12 (55aa9711 6df5 4516 Bf00 A1acf7f7a464 08)

Figure 12 (55aa9711 6df5 4516 Bf00 A1acf7f7a464 08)
A line graph showing the mean change from baseline in six-minute walk distance (meters) over a 12-week study period for three Sildenafil doses (1mg TID, 5mg TID, 20mg TID). The graph plots data points at weeks 4, 8, and 12, with error bars representing standard error for each dose group.*
FDA Label Image

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FDA Label Image

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FDA Label Image

Label Image (Lbl504360185)

Label Image (Lbl504360185)
SILDENAFIL CITRATE 20 mg unit dose packaging label by Unit Dose Services. The label indicates Rx only status, unit dose pouch packaging with a case count of 200, storage instructions, and manufacturer details including Torrent Pharmaceuticals LTD and repackager info. NDC 50436-0185-1 and barcode are visible.*

* 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.