Sildenafil
Product Images NDC 50436-0776

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

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 50436-0776). 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

Figure1 (Figure1)

Figure1 (Figure1)
A line graph depicting estimated cumulative mortality rate (%) over time for three dose groups labeled High dose, Medium dose, and Low dose. The graph includes a number at risk table above, showing sample sizes decreasing over time for each dose group. The High dose group exhibits the highest mortality rate increase, Medium dose intermediate, and Low dose the lowest over the observed period.*
FDA Label Image

Figure2 (Figure2)

Figure2 (Figure2)
A chart titled 'Fold Change and 90% CI' showing fold changes in AUC and Cmax of Sildenafil when coadministered with various interacting drugs. Drugs listed include Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral Contraceptives, Ritonavir, and Saquinavir. The vertical solid line at 1 indicates no change relative to Sildenafil alone. Most drugs show 'No dose adjustment' recommendation, except Ritonavir with 'Coadministration not recommended.' The graph includes 90% confidence intervals for fold changes.*
FDA Label Image

Figure3 (Figure3)

Figure3 (Figure3)
A forest plot chart showing fold change and 90% confidence intervals for various drugs interacting with sildenafil. The x-axis represents change relative to interacting drug alone, with a vertical line at 1 indicating no change. The y-axis lists interacting drugs such as Acenocoumarol, Aspirin, Atorvastatin, Bosentan, Doxazosin, and others, alongside pharmacokinetic parameters like AUC and Cmax. Recommendations for dose adjustment are noted, mostly indicating no dose adjustment except for ritonavir where coadministration is not recommended.*
FDA Label Image

Figure4 (Figure4)

Figure4 (Figure4)
A line graph showing the change from baseline (measured in meters) over Weeks 4, 8, and 12 of study. It compares the effects of sildenafil 40mg TID, placebo, and sildenafil 80mg TID, with data points and error bars indicating variability for each group at each time point.*
FDA Label Image

Figure5 (Figure5)

Figure5 (Figure5)
A forest plot chart comparing placebo and Sildenafil 20 mg TID on placebo-corrected changes in 6-minute walk distance. The chart includes subgroups based on baseline walk distance, etiology, functional capacity class, gender, age, mean PAP, and PVRI. Data points with confidence intervals are shown for each category, illustrating the effect size and variability.*
FDA Label Image

Figure6 (Figure6)

Figure6 (Figure6)
A line graph depicting the percentage of patients without a clinically worsening event over days from randomization, comparing Sildenafil and placebo groups. The x-axis shows days from 0 to 112, and the y-axis shows the percentage from 0% to 100%. Two lines represent Sildenafil (dashed) and placebo (solid), with Sildenafil maintaining a higher percentage over time.*
FDA Label Image

Figure7 (Figure7)

Figure7 (Figure7)
A line plot showing the mean change from baseline (in meters) over weeks 4, 8, and 12 for three Sildenafil dosages: 1 mg TID, 5 mg TID, and 20 mg TID. Each data point includes standard error bars illustrating variability for each dose at each visit week.*
FDA Label Image

Structure (Structure)

Structure (Structure)
Chemical structure diagram of the active ingredient Sildenafil, showing the molecular framework with labeled chemical groups and bonds.*
FDA Label Image

Camber1 (Camber1)

FDA Label Image

Camber2 (Camber2)

FDA Label Image

Image1 (Image1)

Image1 (Image1)
A line graph showing mean change from baseline (in meters) over 12 weeks of study for Sildenafil at doses of 1 mg TID, 5 mg TID, and 20 mg TID. The x-axis represents study weeks (4, 8, 12) and the y-axis shows change from baseline, with error bars indicating standard error for each dose group at each time point.*
FDA Label Image

Label Image (Lbl504360776)

Label Image (Lbl504360776)
Sildenafil 20 mg unit dose pouch label from Unit Dose Services. The label states each tablet contains sildenafil citrate equivalent to 20 mg sildenafil. Packaging contains three tablets per unit dose pouch with 990 pouches per case. Storage instructions indicate 20 to 25°C with allowed excursions. The label includes manufacturer and repackager details, lot number, manufacturing and expiration dates, and barcodes.*

* 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.