Sildenafil Citrate Tablet, Film Coated
Product Images NDC 82868-094

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Sildenafil Citrate (NDC 82868-094). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Northwind Health Company, 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

Label (82868 094 30 Rev A 11 25 Nhc)

Sildenafil Tablets USP 20 mg label showing 30 film-coated tablets for oral use, labeled Rx Only. The label includes storage instructions (20°-25°C), manufacturer Northwind Health Company, LLC, and identifying barcodes and lot information placeholders.*

FDA Label Image

Graph (Sildenafil Tablets Usp 20mg Figure 06)

A line chart showing estimated cumulative mortality rate (%) over time in years. It compares three dose levels labeled High Dose, Medium Dose, and Low Dose, with High Dose having the highest cumulative mortality rate by year 5, followed by Medium Dose, and Low Dose showing the lowest rate. The graph also includes the number of subjects at risk for each dose group over time.*

FDA Label Image

Graph (Sildenafil Tablets Usp 20mg Figure 07)

A forest plot chart depicting the fold change and 90% confidence intervals for drug interactions affecting Sildenafil's Area Under the Curve (AUC) and maximum concentration (Cmax) with various interacting drugs like Atorvastatin, Azithromycin, Bosentan, Cimetidine, and others. The chart also includes dosage adjustment recommendations ranging from 'No dose adjustment' to 'Coadministration not recommended.'*

FDA Label Image

Graph (Sildenafil Tablets Usp 20mg Figure 08)

A chart showing fold change and 90% confidence intervals for various interacting drugs with Sildenafil, comparing changes in pharmacokinetic parameters like AUC and Cmax relative to the interacting drug alone. It includes recommendations on dose adjustment, mostly 'No dose adjustment,' except for Ritonavir where coadministration is not recommended.*

FDA Label Image

Graph (Sildenafil Tablets Usp 20mg Figure 09)

A line graph showing the change from baseline (in meters) over a 12-week study period for four groups: Placebo, Sildenafil 20 mg TID, Sildenafil 40 mg TID, and Sildenafil 80 mg TID. The x-axis represents the week of study (Weeks 4, 8, and 12), and the y-axis represents the change from baseline in meters, with error bars indicating variability. The graph compares the efficacy of different Sildenafil doses versus placebo over time.*

FDA Label Image

Graph (Sildenafil Tablets Usp 20mg Figure 10)

A forest plot displaying placebo-corrected changes in 6-minute walk distance (meters) for Sildenafil 20 mg taken three times daily (TID). The chart compares treatment effects across various patient subgroups such as baseline walk distance, etiology of pulmonary arterial hypertension (PAH), functional class, gender, age, mean pulmonary arterial pressure (PAP), and pulmonary vascular resistance index (PVRI). Each subgroup shows data points with confidence intervals demonstrating the efficacy variation of Sildenafil versus placebo.*

FDA Label Image

Graph (Sildenafil Tablets Usp 20mg Figure 11)

A Kaplan-Meier plot illustrating the percentage of subjects without a clinically worsening event over 112 days from randomization. The graph compares two groups: one treated with Sildenafil and the other with a placebo, showing higher survival without worsening events in the Sildenafil group throughout the study period.*

FDA Label Image

Graph (Sildenafil Tablets Usp 20mg Figure 12)

A line plot showing the mean change from baseline in meters on the vertical axis versus weeks of study (Weeks 4, 8, and 12) on the horizontal axis. It compares Sildenafil dosed at 1 mg TID, 5 mg TID, and 20 mg TID with error bars representing standard error for each treatment at each time point.*

FDA Label Image

Structure Formula (Sildenafil Tablets Usp 20mg Structure)

Chemical structure diagram of Sildenafil, the active ingredient in Sildenafil Citrate tablets, showing molecular bonds and functional groups.*

* 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.