Sildenafil Tablet, Film Coated
Product Images NDC 63187-813

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 63187-813). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Proficient Rx Lp, 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

63187-813-30 (Bottle)

Sildenafil 20 mg tablet packaging label from Proficient Rx LP. The label states 30 tablets per container and lists sildenafil citrate as the active ingredient equivalent to 20 mg sildenafil. Tablets are described as white, film-coated, round and debossed with 'C 89'. Manufacturer is Macleods Pharmaceuticals Ltd., India. Storage instructions and caution to keep medication out of children's reach are included.*

FDA Label Image

Figure-2 (Figure 2)

A forest plot showing the change in pharmacokinetic parameters (Cmax and AUC) of Sildenafil when coadministered with various interacting drugs. The plot displays fold change and 90% confidence intervals relative to Sildenafil alone, with recommendations on dose adjustments or coadministration suitability.*

FDA Label Image

Figure-3 (Figure 3)

A forest plot chart showing fold change and 95% confidence interval for various interacting drugs on the pharmacokinetics of Sildenafil. The chart compares changes in AUC, Cmax, and INR AUC with a reference line at 1 to indicate no change. Recommendations for dose adjustments are listed, mostly advising no dose adjustment, with notes for certain drugs like Ritonavi and Doxazosin variants.*

FDA Label Image

Figure-4 (Figure 4)

A line graph showing the change from baseline in meters over weeks 4, 8, and 12 of study. The y-axis represents change from baseline in meters and the x-axis represents the week of study. Four key groups are plotted: Placebo, Sildenafil 20mg TID, Sildenafil 40mg TID, and Sildenafil 80mg TID, each represented with distinct markers. Data points include variability indicated by vertical error bars.*

FDA Label Image

Figure-5 (Figure 5)

A forest plot chart illustrating placebo-corrected change in 6-minute walk distance in meters for Sildenafil 20 mg TID versus placebo. The chart groups data by baseline walk distance, etiology, pulmonary hypertension criteria, gender, age, mean pulmonary arterial pressure, and pulmonary vascular resistance index, showing point estimates and confidence intervals for each subgroup.*

FDA Label Image

Figure-6 (Figure 6)

A Kaplan-Meier survival curve showing the percentage of subjects without a clinically worsening event over time (days from randomization). The graph compares two groups: one treated with Sildenafil and one with Placebo, with Sildenafil showing a higher percentage of subjects without worsening events throughout the study period.*

FDA Label Image

Sildenafil-citrate (Sildenafil Citrate)

Chemical structure of sildenafil showing its molecular components and functional groups as depicted in the image.*

FDA Label Image

Figure1 (Untitled)

A stepped line graph showing estimated cumulative mortality rate (%) over time (years) for three groups labeled High Dose, Medium Dose, and Low Dose. The mortality rate increases with time, with the High Dose group having the highest cumulative mortality rate and the Low Dose group the lowest. Numbers at risk are displayed above the graph for each time point and dose group.*

* 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.