Sildenafil Tablet, Film Coated
Product Images NDC 68071-5115

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 68071-5115). 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 5115 6)

Label for Sildenafil 20 mg film-coated tablets by NuCare Pharmaceuticals, Inc. The label includes product NDC 68071-5115-6 and indicates a bottle containing 60 tablets. It describes the tablets as round, white or off-white with debossing, and states each tablet contains 20 mg of Sildenafil Citrate equivalent to 20 mg Sildenafil. Manufacturer is Macleods Pharmaceutical Ltd., India. Storage instructions and warnings are also visible.*

FDA Label Image

Figure-10 (Sildenafil Fig 10)

A forest plot showing placebo-corrected change in 6-minute walk distance (meters) for Sildenafil 20 mg TID compared across various subgroups: baseline walk distance, etiology of pulmonary arterial hypertension, PH criteria for functional capacity and therapeutic class, gender, age, mean pulmonary arterial pressure, and pulmonary vascular resistance index. The plot includes sample sizes and confidence intervals for each subgroup comparison.*

FDA Label Image

Figure-11 (Sildenafil Fig 11)

A line graph comparing the percentage of subjects without a clinically worsening event over time between two groups: one receiving Sildenafil and the other a placebo. The x-axis represents days from randomization, while the y-axis represents the percentage without worsening. The graph shows time up to approximately 112 days.*

FDA Label Image

Fig-12 (Sildenafil Fig 12)

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

FDA Label Image

Fig-6 (Sildenafil Fig 6)

A Kaplan-Meier survival curve chart showing estimated cumulative mortality rates over 5 years for three dosage groups: high dose, medium dose, and low dose. The x-axis represents time in years, and the y-axis shows the cumulative mortality rate percentage. Numbers at risk are listed above the graph for each time point and dose group.*

FDA Label Image

Fig-8 (Sildenafil Fig 8)

A forest plot chart showing fold change and 90% confidence intervals for various interacting drugs relative to interacting drug alone. The chart lists drugs on the vertical axis and fold change on the horizontal axis with a reference line at 1, indicating no change. Recommendations on dose adjustments accompany each drug comparison.*

FDA Label Image

Figure-9 (Sildenafil Fig 9)

A line graph illustrating the change from baseline in meters over a 12-week study period on the x-axis (weeks 4, 8, and 12). The y-axis represents change from baseline in meters ranging from -20 to 80. Data points compare placebo, Sildenafil 20 mg TID, Sildenafil 40 mg TID, and Sildenafil 80 mg TID groups, showing trends in distance changes at each time point with error bars.*

FDA Label Image

Figure-7 (Sildenafil Figure 7)

A forest plot chart showing fold change and 90% confidence intervals (CI) of pharmacokinetic parameters AUC and Cmax for sildenafil when coadministered with various interacting drugs. The chart compares each drug against sildenafil alone (vertical line at x=1) and gives dosing recommendations, mostly indicating no dose adjustment, except for ritonavir where coadministration is not recommended.*

FDA Label Image

Str (Sildenafil Str)

Chemical structure of Sildenafil, showing its molecular arrangement with constituent atoms and chemical groups clearly depicted.*

* 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.