Sildenafil
Product Images NDC 43353-345

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 43353-345). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, Llc, 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

Principal Display Panel (20 mg Tablet Bottle Label)

Packaging label for Sildenafil 20mg tablets, containing 10 tablets. The label includes storage instructions, repackaging information by Aphena Pharma Solutions - Tennessee, LLC, and manufacturer details by Greenstone LLC, Peapack, NJ. The label displays NDC number 43353-0345, batch number, expiration date, and is marked RX only.*

FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Figure 1 (Sildenafil 01)

A Kaplan-Meier survival curve chart showing estimated cumulative mortality rates (%) over time (years) for three dosage groups: High Dose, Medium Dose, and Low Dose. The chart includes the number of subjects at risk at multiple time points for each dose group, with mortality rates increasing over five years most sharply for the High Dose group, followed by Medium Dose, and lowest for Low Dose.*

FDA Label Image

Chemical Structure (Sildenafil 02)

Chemical structure of Sildenafil, showing detailed molecular bonds and functional groups including a sulfonyl group, nitrogen-containing rings, and carboxylic acid groups.*

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Figure 2 (Sildenafil 03)

A forest plot showing the fold change and 90% confidence interval for the area under the curve (AUC) and maximum concentration (Cmax) of Sildenafil when coadministered with various interacting drugs. The chart includes drugs like Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral Contraceptives, Ritonavir, and Saquinavir, and provides dosing recommendations based on these pharmacokinetic changes.*

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Figure 3 (Sildenafil 04)

A chart displaying fold change and 90% confidence intervals for various interacting drugs with sildenafil. The x-axis shows the change relative to the interacting drug alone, ranging from 0.5 to 2. Interacting drugs are listed on the left with measures like INR, AUC, Cmax, and BT noted. Recommendations for dose adjustments are provided, mostly indicating no dose adjustment except for ritonavir, for which coadministration is not recommended.*

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Figure 4 (Sildenafil 05)

A line graph depicting change from baseline in meters over 12 weeks of study with three groups: Placebo, Sildenafil 20mg TID, and Sildenafil 40mg TID. The graph shows mean change and error bars at weeks 4, 8, and 12, illustrating increasing values over time for both Sildenafil doses compared to placebo.*

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Figure 5 (Sildenafil 06)

A chart displaying placebo-corrected changes in 6-minute walk distance (meters) for Sildenafil 20 mg taken three times daily (TID) across various subgroups. Subgroups include baseline walk distance, etiology of pulmonary arterial hypertension (PAH), PH criteria class, gender, age, mean pulmonary arterial pressure (PAP), and pulmonary vascular resistance index (PVRI). Data is presented with point estimates and confidence intervals for Sildenafil compared to placebo.*

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Figure 6 (Sildenafil 07)

A line graph comparing the percentage of subjects without a clinically worsening event over time between Sildenafil and Placebo groups. The x-axis represents days from randomization, and the y-axis shows the percentage without worsening events. The Sildenafil group shows a higher percentage maintained over time compared to Placebo.*

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Figure 7 (Sildenafil 08)

A line graph showing 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 weeks of study (4, 8, 12) and the y-axis shows the change from baseline. Each dose group is marked with distinct symbols, and error bars represent standard error for each treatment at each visit.*

FDA Label Image

Greenstone Logo (Sildenafil 09)

* 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.