Sildenafil
Product Images NDC 50436-0033

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 50436-0033). 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

Label Image (Lbl504360033)

Sildenafil 20 mg unit dose pouch label by Unit Dose Services with product NDC 50436-0033. The label includes drug strength, active ingredient equivalence, packaging information for two tablets per pouch, storage instructions, distributor details, and barcode information. The label also notes prescription-only status and directions to refer to accompanying prescription information.*

FDA Label Image

Figure 1 (Sildenafil 01)

FDA Label Image

Chemical Structure (Sildenafil 02)

Chemical structure of sildenafil with its molecular components and a tartaric acid moiety shown as part of the structure.*

FDA Label Image

Figure 2 (Sildenafil 03)

A horizontal dot plot chart showing fold change and 90% confidence intervals of drug interactions with Sildenafil. It compares the area under the curve (AUC) and maximum concentration (Cmax) for various interacting drugs relative to Sildenafil alone, with recommendations on dose adjustment provided on the right. The drugs listed include Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral Contraceptives, Ritonavir, and Saquinavir.*

FDA Label Image

Figure 3 (Sildenafil 04)

A chart titled 'Fold Change and 90% CI' displaying the impact of various interacting drugs on Sildenafil, including drugs like Acenocoumarol, Aspirin, Atorvastatin, and others. The horizontal axis shows fold change relative to the interacting drug alone, with a vertical line at 1. The chart includes recommendations for dose adjustments, mainly stating 'No dose adjustment,' except for Ritonavir, where coadministration is not recommended. Additional notes clarify dosage and specific drug effects on Sildenafil pharmacokinetics.*

FDA Label Image

Figure 4 (Sildenafil 05)

A line graph showing change from baseline measured in meters on the y-axis over a 12-week study period on the x-axis, with points at week 4, week 8, and week 12. The graph compares three groups: Placebo, Sildenafil 20mg TID, and Sildenafil 40mg TID, each represented by different symbols. Error bars indicate variability at each time point.*

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Figure 5 (Sildenafil 06)

A scatter plot with horizontal error bars depicting placebo-corrected changes in 6-minute walk distance in meters for Sildenafil 20 mg taken three times daily versus placebo. Data are subgrouped by baseline walk distance, etiology, PH functional class, gender, age, mean pulmonary artery pressure, and pulmonary vascular resistance index. The plot compares the number of subjects in each subgroup and displays treatment effects with confidence intervals.*

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Figure 6 (Sildenafil 07)

A line graph comparing the percentage of patients without a clinically worsening event over time between Sildenafil and Placebo groups. The x-axis represents days from randomization up to 112 days, and the y-axis shows the percentage without a clinically worsening event, starting near 100%. Sildenafil's line remains higher throughout the period compared to Placebo, indicating better maintenance of condition without worsening events.*

FDA Label Image

Figure 7 (Sildenafil 08)

This figure is a line graph illustrating the mean change from baseline (in meters) over 12 weeks of study for Sildenafil at 1mg, 5mg, and 20mg taken TID. The x-axis represents the weeks of study (Week 4, 8, 12), and the y-axis shows change from baseline up to 70 meters. Data points include standard error bars for each dose at each time point.*

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.