Sildenafil
Product Images NDC 45865-833

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 45865-833). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Medsource Pharmaceuticals, 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

Pdp (833)

Sildenafil Tablets 20 mg packaging label from Medsource Pharmaceuticals. The label indicates the tablets are generic for Revatio, white, round, film-coated, and includes dosing instructions and warnings about dizziness, drowsiness, and nitrate medicine interactions. Manufacturer information shows Macleods Pharm. Ltd., India, with lot number and expiration date fields.*

FDA Label Image

Figure-10 (Sildenafil Fig 10)

A forest plot chart showing placebo-corrected changes in 6-minute walk distance (meters) for Sildenafil 20 mg taken three times daily. The chart compares subgroups based on baseline walk distance, etiology, PH functional class, gender, age, mean pulmonary artery pressure (PAP), and pulmonary vascular resistance index (PVRI). Each subgroup displays point estimates and confidence intervals for treatment effect differences between Sildenafil and placebo groups.*

FDA Label Image

Figure-11 (Sildenafil Fig 11)

A line graph showing the percentage of subjects without a clinically worsening event over time from randomization. The x-axis represents days from randomization (0 to 112), and the y-axis shows percentage values from 0 to 100. Two lines compare placebo and Sildenafil groups, with Sildenafil showing a higher percentage without worsening events throughout the study period.*

FDA Label Image

Fig-12 (Sildenafil Fig 12)

A line chart depicting the mean change from baseline in meters over 12 weeks for Sildenafil at doses of 1 mg, 5 mg, and 20 mg taken three times daily (TID). The x-axis represents the week of study (Weeks 4, 8, and 12), and the y-axis shows the change from baseline. Data points include error bars indicating the standard error for each dose group at each time point.*

FDA Label Image

Fig-6 (Sildenafil Fig 6)

A step plot showing estimated cumulative mortality rate percentage over time in years for three dosage groups labeled High dose, Medium dose, and Low dose. The cumulative mortality rate increases over five years, with High dose showing the highest rate, Medium dose intermediate, and Low dose the lowest. The chart includes a risk table above the graph indicating the number of subjects at risk at various time points for each dose group.*

FDA Label Image

Fig-8 (Sildenafil Fig 8)

A horizontal forest plot showing fold change and 90% confidence intervals for various drugs interacting with sildenafil. The chart compares pharmacokinetic parameters (AUC, Cmax, INR, bleeding time) relative to each drug alone, with recommended dose adjustments noted, mostly indicating 'No dose adjustment' except for ritonavir where coadministration is not recommended.*

FDA Label Image

Figure-9 (Sildenafil Fig 9)

A line graph depicting the change from baseline (in meters) over 12 weeks of study for Sildenafil at doses of 20 mg, 40 mg, and 80 mg taken three times daily (TID), compared to placebo. The x-axis represents weeks of study (4, 8, and 12) and the y-axis shows change from baseline. The graph includes error bars for each data point.*

FDA Label Image

Figure-7 (Sildenafil Figure 7)

A forest plot chart titled 'Fold Change and 90% CI' showing the effect of various interacting drugs on Sildenafil's AUC and Cmax. The chart lists drugs such as Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral Contraceptives, Ritonavir, and Saquinavir. Fold changes are graphically represented with confidence intervals and a vertical reference line at 1, indicating no change. Recommendations for dose adjustment are included for each drug interaction.*

FDA Label Image

Str (Sildenafil Str)

Chemical structure diagram of Sildenafil, showing its molecular components including ring structures, methyl groups, and functional groups consistent with its known chemical formula.*

* 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.