Sildenafil Tablet
Product Images NDC 63187-789

8 FDA label images from Proficient Rx Lp · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 63187-789). 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

F7c6df1a-figure-01 (Sildenafil Tablets 1)

F7c6df1a-figure-01 (Sildenafil Tablets 1)
A line graph depicting estimated cumulative mortality rates (%) over time in years for three dose groups: high, medium, and low dose. The graph includes stepwise cumulative mortality curves for each dose and the numbers at risk at various time points across the study duration up to 5 years.*
FDA Label Image

Structural Formula (Sildenafil Tablets 2)

Structural Formula (Sildenafil Tablets 2)
Chemical structure of Sildenafil showing its molecular framework with nitrogen, oxygen, carbon, and hydrogen atoms arranged in characteristic rings and side chains.*
FDA Label Image

Figure 7 (Sildenafil Tablets 3)

Figure 7 (Sildenafil Tablets 3)
A chart showing fold change and 90% confidence intervals for AUC and Cmax parameters of various interacting drugs relative to Sildenafil alone. It lists drugs like Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral Contraceptives, Ritonavir, and Saquinavir, with recommendations on dose adjustment or coadministration guidance for each.*
FDA Label Image

Figure 8 (Sildenafil Tablets 4)

Figure 8 (Sildenafil Tablets 4)
A forest plot chart depicting fold changes and 90% confidence intervals of pharmacokinetic parameters (such as AUC, Cmax, INR, and bleeding time) for sildenafil when coadministered with various interacting drugs. The chart includes recommendations on dose adjustments ranging from no dose adjustment to coadministration not recommended for specific drugs.*
FDA Label Image

F7c6df1a-figure-05 (Sildenafil Tablets 5)

F7c6df1a-figure-05 (Sildenafil Tablets 5)
A line graph showing changes from baseline (in centimeters) over time at study weeks 4, 6, and 12. It compares different dosing regimens of Sildenafil tablets (40 mg TID and 60 mg TID) against placebo and Sildenafil 20 mg TID, with error bars indicating variability.*
FDA Label Image

Figure 10 (Sildenafil Tablets 6)

Figure 10 (Sildenafil Tablets 6)
A data table presenting placebo-corrected changes in 6-minute walk distance (meters) with Sildenafil 20 mg taken three times daily versus placebo. It summarizes outcomes by baseline walk distance, etiology, pulmonary hypertension criteria, gender, age, mean pulmonary artery pressure, and pulmonary vascular resistance index, including sample sizes and confidence intervals for each subgroup.*
FDA Label Image

F7c6df1a-figure-07 (Sildenafil Tablets 7)

F7c6df1a-figure-07 (Sildenafil Tablets 7)
A line graph comparing the percentage of participants without a clinically worsening event over time between Sildenafil and placebo groups. The x-axis represents days from randomization (0 to 112), and the y-axis shows the percentage without worsening events (0 to 100%). Sildenafil's line remains higher than placebo throughout the period, indicating a difference in event rates between groups.*
FDA Label Image

63187-789-10 (Sildenafil Tablets 8)

63187-789-10 (Sildenafil Tablets 8)
Packaging label for Sildenafil 20 mg oral tablets by Proficient Rx LP, containing 10 film-coated tablets. The label includes product ID PS078910 and manufacturing information from Amneal Pharmaceuticals Pvt. Ltd., India. It notes the tablets are white to off-white, round, with specific debossing. The label also shows the National Drug Code (NDC) 63187-789-10 and storage instructions.*

* 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.