Sildenafil Tablet, Film Coated
Product Images NDC 43063-982

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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)

43063982 Label (43063982)
This is a medication information sheet for Sildenafil, a drug that comes in 20mg tablets and is used to treat certain types of erectile dysfunction in men. The text includes details about the product, such as the lot number, expiration date, and dosage instructions. It also gives a warning about potential side effects and provides an FDA contact number for reporting them. The text also contains some technical information for pharmacists, including the NDC number and the drug's chemical makeup.*
FDA Label Image

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

Figure 6: Kaplan-meier Plot Of Mortality By Sildenafil Dose (Sildenafil Fig1)
This appears to be a chart showing the estimated cumulative mortality rate given different doses of some substance over time in years. The rates are given in percentages and high, medium, and low doses are compared.*
FDA Label Image

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

Figure 7. Effects Of Other Drugs On Sildenafil Pharmacokinetics (Sildenafil Fig2)
This text appears to be a chart or table that provides recommendations for dose adjustments of different drugs when administered with Sildenafil. The chart includes drug names, specific measurements such as AUC (area under the curve) and Cmax (maximum plasma concentration), and whether a dose adjustment is recommended or not for each drug when taken with Sildenafil. Additionally, it includes some notes about the clinical studies, the lack of benefit on exercise capacity when sildenafil added to bosentan therapy, and a line graph depicting the change relative to Sildenafil alone.*
FDA Label Image

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

Figure 8 Effects Of Sildenafil On Other Drugs (Sildenafil Fig3)
This is a list of interacting drugs with Acenocoumarol. The data presented includes the effects on different parameters, such as INR, AUC, Cmax and BT, as well as recommendations on dose adjustments. No adjustments are needed for most drugs, but coadministration with some drugs is not recommended. The effect of ritonavir on sildenafil PK is also described.*
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)

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)
This is a graphical representation of the change from baseline in 6-minute walk distance in a study that evaluated a placebo and two doses of sildenafil (40mg and 80mg) at weeks 4, 8, and 12. The mean and 95% confidence intervals are shown in meters. No useful information can be extracted from the output provided.*
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)

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 is a statistical graph showing the placebo-corrected change from baseline in 6-minute walk distance (meters) at week 12 by study subpopulation in Study 1. The graph displays mean values with a 95% confidence interval. There are several categories of the subpopulation, including idiopathicPAH, etiology PHCD, PAH-surgical repair, PH etiology for functional capacity, and therapeutic class. There are also details given for baseline walk and distance (in meters), the number of people in each subpopulation group, median age, mean PAP, and PR. The x-axis is the Placebo-corrected Change in 6-Minute Walk Distance (m), while the y-axis is the study subpopulation.*
FDA Label Image

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

Figure 11. Kaplan-meier Plot Of Time (in Days) To Clinical Worsening Of Pah In Study 2 (Sildenafil Fig6)
The text describes a Kaplan-Meier plot that displays the time (in days) to clinical worsening of PAH in Study 2. The x-axis represents the days from randomization, and the y-axis represents the percentage without a clinically worsening event. The plot compares two interventions, Placebo, and Sildenafil. The description does not provide any further information or context regarding Study 2 or the interventions used.*
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)

Figure 12. Mean Change From Baseline In Six Minute Walk (meters) By Visit To Week 12 – Itt Population Sildenafil Protocol A1481244 (Sildenafil Fig7)
The text contains data related to a study analyzing the mean change from baseline for different treatments over a period of 12 weeks. The treatments mentioned are Sidenafil in different doses (5mgTD, 20mg TID). However, the text is not complete and does not provide sufficient information to understand the study in detail.*
FDA Label Image

Chemical Structure (Sildenafil Str)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.