Sildenafil Tablet, Film Coated
Product Images NDC 68071-2213

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 68071-2213). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Nucare Pharmaceuticals,inc., 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 (68071 2213 9)

Label for Sildenafil 20 mg tablets by NuCare Pharmaceuticals, Inc., showing a 90-tablet package. The label includes the NDC 68071-2213-9, states Rx Only, and provides manufacturer information as Hafero Labs Limited, Maharashtra, India. It also includes warnings to keep out of reach of children and storage instructions for controlled temperature between 68-77°F.*

FDA Label Image

Figure1 (Figure1)

A line graph depicting the estimated cumulative mortality rate (%) over time for three groups labeled High dose, Medium dose, and Low dose. The vertical axis shows mortality rate from 0 to 25%, and the horizontal axis represents time in years from 0 to 5. The graph includes the number of subjects at risk at different time points for each dose group.*

FDA Label Image

Figure2 (Figure2)

A forest plot displaying fold changes and 90% confidence intervals (CI) for AUC and Cmax of Sildenafil when coadministered with various interacting drugs. The x-axis shows change relative to Sildenafil alone, with a vertical line at 1. Listed interacting drugs include Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral Contraceptives, Ritonavir, and Saquinavir. Recommendations about dose adjustment or coadministration accompany each drug interaction.*

FDA Label Image

Figure3 (Figure3)

A forest plot chart showing the fold change and 90% confidence intervals for various interacting drugs with sildenafil. The chart illustrates the change relative to each interacting drug alone, with most recommendations indicating no dose adjustment except for ritonavir, where coadministration is not recommended. The x-axis represents change relative to the interacting drug, and the chart includes specific drugs such as acenocoumarol, aspirin, atorvastatin, bosentan, doxazosin, and others.*

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Figure4 (Figure4)

A line graph showing change from baseline in a measured variable over weeks 4, 8, and 12. The graph compares four groups: Placebo, Sildenafil 10 mg TID, Sildenafil 40 mg TID, and Sildenafil 80 mg TID. Each group's data points include error bars indicating variability.*

FDA Label Image

Figure5 (Figure5)

A forest plot chart comparing placebo and Sildenafil 20 mg taken three times daily (TID) showing placebo-corrected changes in 6-minute walk distance. The chart presents data across categories including baseline walk distance, etiology, pulmonary hypertension criteria, gender, age, mean pulmonary artery pressure (PAP), and pulmonary vascular resistance index (PVRI). Each category displays subgroup sample sizes, point estimates, and confidence intervals.*

FDA Label Image

Figure6 (Figure6)

A line graph comparing the percentage without a clinically worsening event over time between placebo and Sildenafil groups. The x-axis represents days from randomization (0 to 112), and the y-axis represents percentage without event (0% to 100%). Two lines are shown: a dashed line for Sildenafil and a solid line for placebo, with the Sildenafil group maintaining higher percentages throughout the study period.*

FDA Label Image

Figure7 (Figure7)

A line plot showing mean change from baseline (meters) over Weeks 4, 8, and 12 of study for Sildenafil at doses 1 mg TID, 5 mg TID, and 20 mg TID. The graph includes error bars representing standard error for each treatment group at each visit up to week 12.*

FDA Label Image

Structure (Structure)

Chemical structure of Sildenafil, showing its molecular composition and arrangement of atoms as typically depicted in a structural formula diagram.*

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Camber1 (Camber1)

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Camber2 (Camber2)

FDA Label Image

Image1 (Image1)

A line plot showing mean change from baseline (in meters) over weeks 4, 8, and 12 for three Sildenafil doses: 1 mg TID, 5 mg TID, and 20 mg TID. Each dose is represented by distinct markers, with error bars indicating standard error at each time point during the study.*

* 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.