Sildenafil
Product Images NDC 68071-2566

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 68071-2566). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Nucare 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

Pdp (68071 2566 3)

Sildenafil 20 mg tablets label from NuCare Pharmaceuticals, Inc. The label indicates #30 tablets per package, prescription only, with each film-coated tablet containing sildenafil citrate equivalent to 20 mg sildenafil. The tablets are described as round, white to off-white, and debossed with 'J' and '95'. The label includes manufacturer information, lot number, expiration details, and storage instructions at controlled temperature 68-77°F.*

FDA Label Image

Figure1 (Figure1)

A line plot depicting the estimated cumulative mortality rate (%) over time stratified by dosage groups labeled as High dose, Medium dose, and Low dose. The graph includes the number at risk for each dose group at various time points along the x-axis, showing distinct mortality trends by dose intensity.*

FDA Label Image

Figure2 (Figure2)

A horizontal dot plot chart showing fold change and 90% confidence intervals for various interacting drugs' AUC and Cmax relative to Sildenafil alone. Drugs listed include Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral Contraceptives, Ritonavir, and Saquinavir. Recommendations for dose adjustment or coadministration appear alongside, mostly indicating no dose adjustment except Ritonavir with coadministration not recommended.*

FDA Label Image

Figure3 (Figure3)

A forest plot chart illustrating the fold change and 90% confidence interval in various pharmacokinetic parameters (e.g., AUC, Cmax, INR AUC, bleeding time) relative to different interacting drugs when combined with sildenafil. The chart includes drugs like Acenocoumarol, Aspirin, Atorvastatin, Bosentan, and others, along with dosage recommendations such as "No dose adjustment" or "Coadministration not recommended". The horizontal axis shows change relative to the interacting drug alone, with a reference line at 1.*

FDA Label Image

Figure4 (Figure4)

A line chart comparing the change from baseline in a variable over 12 weeks for four groups: Placebo, Sildenafil 10 mg TID, Sildenafil 40 mg TID, and Sildenafil 80 mg TID. The x-axis shows the week of study (Week 4, 8, 12) and the y-axis shows the change from baseline in meters, with data points and error bars for each group at each time point.*

FDA Label Image

Figure5 (Figure5)

Forest plot chart showing placebo-corrected changes in 6-minute walk distance (meters) among Sildenafil 20 mg TID and placebo groups across subgroups including baseline walk distance, etiology, pulmonary hypertension functional class, gender, age, mean pulmonary arterial pressure, and PVR. Each subgroup comparison includes participant counts and 95% confidence intervals represented by horizontal lines and point estimates marked with dots.*

FDA Label Image

Figure6 (Figure6)

A Kaplan-Meier survival curve chart comparing the percentage of subjects without a clinically worsening event over days from randomization between Sildenafil and placebo groups. The x-axis represents days from randomization, and the y-axis shows the percentage without a worsening event. Distinct lines for Sildenafil and placebo illustrate comparative outcomes over a 112-day period.*

FDA Label Image

Figure7 (Figure7)

A line plot showing mean change from baseline in meters over a 12-week study period for Sildenafil at 1 mg, 5 mg, and 20 mg three times daily (TID) doses. Data points at weeks 4, 8, and 12 include error bars representing the standard error for each treatment group.*

FDA Label Image

Structure (Structure)

Chemical structure of sildenafil, displaying its molecular framework with characteristic rings and functional groups as depicted in the image.*

FDA Label Image

Camber1 (Camber1)

FDA Label Image

Camber2 (Camber2)

FDA Label Image

Image1 (Image1)

A line plot graph showing the mean change from baseline (in meters) over a 12-week study period for Sildenafil at doses of 1 mg TID, 5 mg TID, and 20 mg TID. The x-axis represents study weeks (4, 8, 12), and the y-axis shows change from baseline ranging from -10 to 70 meters. Data points include error bars indicating standard error for each dose group at each time point.*

* 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.