Sildenafil
Product Images NDC 53217-198

10 FDA label images from Aidarex Pharmaceuticals Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 53217-198). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aidarex Pharmaceuticals 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

Figure1 (Sildenafil 1)

Figure1 (Sildenafil 1)
A Kaplan-Meier curve chart depicting estimated cumulative mortality rates over time for three different doses labeled as High dose, Medium dose, and Low dose. The x-axis represents time while the y-axis shows the estimated cumulative mortality rate in percentage. Numbers at risk are presented at multiple time points for each dose group.*
FDA Label Image

Image Description (Sildenafil 10)

Image Description (Sildenafil 10)
Sildenafil 20 mg tablet label from Aidarex Pharmaceuticals LLC. The label indicates a package of 10 tablets with each tablet containing 20 mg of sildenafil citrate. The tablets are white, round, and film-coated, with "Q" on one side and "96" on the reverse. The label includes multiple NDC numbers and manufacturer details for Hetero Labs Limited India.*
FDA Label Image

Structure (Sildenafil 2)

Structure (Sildenafil 2)
Chemical structure diagram of Sildenafil, showing its molecular framework with labeled functional groups and rings consistent with the active pharmaceutical ingredient.*
FDA Label Image

Figure2 (Sildenafil 3)

Figure2 (Sildenafil 3)
A chart showing fold change and 90% confidence intervals for area under the curve (AUC) and maximum concentration (Cmax) of Sildenafil when coadministered with various interacting drugs. The vertical line at 1 represents no change relative to Sildenafil alone. Recommendations on dose adjustment for each interacting drug are listed, with most showing no dose adjustment except Ritonavi, where coadministration is not recommended.*
FDA Label Image

Figure3 (Sildenafil 4)

Figure3 (Sildenafil 4)
A horizontal bar chart showing fold change and 90% confidence intervals for various interacting drugs compared to interacting drug alone, with recommendations for dose adjustment. Drugs listed include Acenocoumarol, Aspirin, Atorvastatin, Bosentan, Doxazosin at various doses, Ethinyloestradiol, Levonorgestrel, Phenprocoumon, Ritonavir, Saquinavir, and Tolbutamide. Most drugs show 'No dose adjustment' recommendation except Ritonavir, which lists 'Coadministration not recommended.' The x-axis measures change relative to interacting drug alone.*
FDA Label Image

Figure4 (Sildenafil 5)

Figure4 (Sildenafil 5)
A line and scatter plot showing changes from baseline over 12 weeks of study for Sildenafil 40 mg TID, Sildenafil 80 mg TID, and placebo groups. The x-axis represents weeks of study (4, 8, and 12), and the y-axis shows change from baseline in meters. Error bars indicate variability.*
FDA Label Image

Figure5 (Sildenafil 6)

Figure5 (Sildenafil 6)
A forest plot comparing placebo and sildenafil effects on 6-minute walk distance across subgroups including baseline walk distance, etiology, pulmonary hypertension criteria, gender, age, mean pulmonary artery pressure, and pulmonary vascular resistance index. The plot shows point estimates and 95% confidence intervals for sildenafil 20 mg TID relative to placebo-corrected change in walk distance.*
FDA Label Image

Figure6 (Sildenafil 7)

Figure6 (Sildenafil 7)
A line graph comparing the percentage of subjects without a clinically worsening event over days from randomization between placebo and Sildenafil groups. The graph shows data trends for both groups across a timeline extending to about 112 days, with Placebo and Sildenafil represented by distinct lines.*
FDA Label Image

Address1 (Sildenafil 8)

FDA Label Image

Address2 (Sildenafil 9)

* 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.