Sildenafil
Product Images NDC 53002-1719

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 53002-1719). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Rpk 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

Image 1

A step plot chart displaying estimated cumulative mortality rate (%) over a period of 5 years. The chart compares three dose groups labeled High Dose, Medium Dose, and Low Dose, showing higher mortality rates with increasing dose levels. The number at risk decreases over time for each group.*

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Image 2

Chemical structure diagram of the active ingredient Sildenafil, depicting its molecular arrangement with labeled functional groups and bonds.*

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Image 3

A dot plot chart depicting the fold change and 90% confidence interval for the interaction between Sildenafil and various drugs including Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral Contraceptives, Ritonavir, and Saquinavir. The chart shows changes in AUC and Cmax relative to Sildenafil alone, with a vertical solid line at 1 representing no change, and provides dosing recommendations such as 'No dose adjustment' or 'Coadministration not recommended.'*

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Image 4

A horizontal error bar chart illustrating fold change and 90% confidence intervals for various interacting drugs relative to the interacting drug alone. The chart includes drugs like Acenocoumarol, Aspirin, Atorvastatin, Bosentan, various doses of Doxazosin, Ethinyloestradiol, Levonorgestrel, Phenprocoumon, Ritonavir, Saquinavir, and Tolbutamide. Recommendations on dose adjustments are displayed to the right, mostly indicating no dose adjustment except for Ritonavir where coadministration is not recommended. The x-axis ranges from 0.5 to 2, showing pharmacokinetic changes relative to the interacting drug alone.*

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Image 5

A line plot showing change from baseline in meters on the y-axis versus week of study on the x-axis (Weeks 4, 8, and 12). The plot compares four groups: Placebo, Sildenafil 20mg TID, Sildenafil 40mg TID, and Sildenafil 80mg TID, with data points and error bars at each week interval.*

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Image 6

A forest plot displaying the placebo-corrected change in 6-minute walk distance (in meters) for Sildenafil 20 mg taken three times daily. The plot stratifies data by baseline walk distance, etiology, pulmonary hypertension criteria, gender, age, mean pulmonary arterial pressure, and pulmonary vascular resistance index, with horizontal error bars representing confidence intervals for each subgroup.*

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Image 7

A survival curve chart comparing the percentage of patients without a clinically worsening event over a 112-day period after randomization. It shows two lines: one for placebo and one for Sildenafil, illustrating the difference in clinical outcomes between the two groups over time.*

FDA Label Image

Image 8

A line graph showing mean change from baseline in meters over 12 weeks of study for Sildenafil at 1 mg, 5 mg, and 20 mg administered three times daily (TID). The y-axis measures change from baseline, and the x-axis shows weeks 4, 8, and 12. Error bars represent standard error for each treatment at each visit.*

FDA Label Image

Label Image (Lbl530021719)

Sildenafil 20 mg tablets packaging label from RPK Pharmaceuticals, Inc. The label indicates a 30-tablet bottle with instructions to take the tablets as directed. It includes barcode, lot number, expiration date, and patient instructions placeholders, along with various regulatory and labeling information.*

* 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.