Sildenafil Tablet, Film Coated
Product Images NDC 43063-982

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 43063-982). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Pd-rx 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

43063982 Label (43063982)

The image shows a prescription drug label for Sildenafil USP 20 mg film-coated tablets. The label indicates a package of 30 tablets with NDC 43063-982-30. It is labeled by PD-Rx Pharmaceuticals, Inc., Oklahoma City, OK. The label includes warnings to keep out of reach of children, storage instructions, and spaces to record tablet dosage frequency. Additional details include lot number C22E02 and expiration date 03/2024.*

FDA Label Image

Figure 6: Kaplan-meier Plot Of Mortality By Sildenafil Dose (Sildenafil Fig1)

A line chart showing estimated cumulative mortality rate (%) over time in years for three dosage groups labeled High Dose, Medium Dose, and Low Dose. The vertical axis ranges from 0 to 25 percent, and the horizontal axis spans 0 to 5 years. Mortality rates increase over time, with High Dose consistently highest, Medium Dose intermediate, and Low Dose lowest. The number of subjects at risk at various time points is indicated above the graph for each dose group.*

FDA Label Image

Figure 7. Effects Of Other Drugs On Sildenafil Pharmacokinetics (Sildenafil Fig2)

A chart showing the fold change and 90% confidence interval of drug interaction effects on Sildenafil's AUC and Cmax relative to Sildenafil alone. It compares interacting drugs such as Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral contraceptives, Ritonavir, and Saquinavir, with recommendations on dose adjustment, mostly indicating no dose adjustment except for Ritonavir where coadministration is not recommended.*

FDA Label Image

Figure 8 Effects Of Sildenafil On Other Drugs (Sildenafil Fig3)

A chart showing fold change and 90% confidence interval for various drug interactions with sildenafil. It compares changes relative to the interacting drug alone, measured by parameters such as INR AUC, INR Cmax, bleeding time, AUC, and Cmax. The chart includes dosage details for Doxazosin (25 mg, 50 mg, 100 mg) and notes recommendations on dose adjustments, including no dose adjustment for most drugs except coadministration not recommended for ritonavir.*

FDA Label Image

Figure 9. Change From Baseline In 6-minute Walk Distance (meters) At Weeks 4, 8, And 12 In Study 1: Mean (95% Confidence Interval) (Sildenafil Fig4)

A line graph titled 'Change from Baseline in 6-Minute Walk Distance (meters) at Weeks 4, 8, and 12 in Study 1: Mean (95% Confidence Interval)'. The x-axis shows weeks of study (4, 8, and 12), and the y-axis shows the change from baseline in meters ranging from -20 to 80. Data points represent placebo and Sildenafil doses of 20 mg, 40 mg, and 80 mg taken three times daily (TID). Each group is marked with distinct symbols indicating mean changes and their 95% confidence intervals.*

FDA Label Image

Figure 10. Placebo-corrected Change From Baseline In 6-minute Walk Distance (meters) At Week 12 By Study Subpopulation In Study 1: Mean (95% Confidence Interval) (Sildenafil Fig5)

This figure presents a forest plot showing the placebo-corrected change in 6-minute walk distance (meters) at week 12 for sildenafil 20 mg TID compared to placebo across various subpopulations. Subgroups analyzed include baseline walk distance, etiology of pulmonary arterial hypertension (PAH), PH functional capacity class, gender, age, mean pulmonary artery pressure (PAP), and pulmonary vascular resistance index (PVRI). Mean differences with 95% confidence intervals are displayed for each subgroup.*

FDA Label Image

Figure 11. Kaplan-meier Plot Of Time (in Days) To Clinical Worsening Of Pah In Study 2 (Sildenafil Fig6)

Kaplan-Meier plot depicting time in days to clinical worsening of PAH (pulmonary arterial hypertension) over 112 days from randomization. The plot compares percentage without clinical worsening between two groups: placebo and Sildenafil. The x-axis shows days from randomization, and the y-axis shows the percentage without a clinically worsening event.*

FDA Label Image

Figure 12. Mean Change From Baseline In Six Minute Walk (meters) By Visit To Week 12 – Itt Population Sildenafil Protocol A1481244 (Sildenafil Fig7)

A line plot displaying the mean change from baseline (in meters) over a 12-week study period for Sildenafil tablets at 1 mg, 5 mg, and 20 mg doses taken three times daily (TID). The Y-axis shows change from baseline in meters, while the X-axis shows weeks 4, 8, and 12. Error bars indicate standard error for each dose at each visit.*

FDA Label Image

Chemical Structure (Sildenafil Str)

Chemical structure of Sildenafil depicted as a detailed molecular diagram showing the arrangement of its atoms and bonds, including the heterocyclic rings and functional groups present.*

* 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.