Sildenafil
Product Images NDC 50436-1210

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 50436-1210). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Unit Dose Services, 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 Image (Lbl504361210)

Sildenafil 20 mg unit dose label from Unit Dose Services, product NDC 50436-1210. The label indicates three film-coated tablets per unit dose pouch with 250 pouches per case. It includes administration information, storage instructions, manufacturer details (Macleods Pharmaceuticals Ltd., Baddi, India), and repackager information (Unit Dose Services, LLC, St. Louis, MO).*

FDA Label Image

Figure-10 (Sildenafil Fig 10)

A forest plot depicting the placebo-corrected change in 6-minute walk distance (meters) for Sildenafil 20 mg TID in various subgroups of patients. Subgroups include baseline walk distance, etiology of pulmonary arterial hypertension, functional capacity and therapeutic class, gender, age, mean pulmonary artery pressure (PAP), and pulmonary vascular resistance index (PVRI). Each subgroup shows point estimates and confidence intervals for the treatment effect.*

FDA Label Image

Figure-11 (Sildenafil Fig 11)

A survival-type line graph showing the percentage without a clinically worsening event over days from randomization. Two curves represent placebo and Sildenafil groups, with the Sildenafil group showing a higher percentage over time. The x-axis is labeled 'Day from Randomization' and the y-axis 'Percentage Without a Clinically Worsening Event.' A legend distinguishes the placebo and Sildenafil groups.*

FDA Label Image

Fig-12 (Sildenafil Fig 12)

A line graph showing the mean change from baseline (meters) over 12 weeks for Sildenafil at doses 1 mg, 5 mg, and 20 mg taken three times daily (TID). The x-axis represents weeks of study (Week 4, 8, and 12), and the y-axis shows the change in meters, with error bars indicating the standard error for each treatment.*

FDA Label Image

Fig-6 (Sildenafil Fig 6)

A line chart showing the estimated cumulative mortality rate (%) over time in years. The chart compares three groups labeled 'High dose,' 'Medium dose,' and 'Low dose,' with corresponding mortality rates rising over a five-year period. The number of subjects at risk is displayed above the graph for each group at various time points.*

FDA Label Image

Fig-8 (Sildenafil Fig 8)

A forest plot chart showing the fold change and 90% confidence interval of various interacting drugs with Sildenafil, relative to each drug alone. The chart includes drugs such as Acenocoumarol, Aspirin, Atorvastatin, Bosentan, Doxazosin (1, 2, and 3), Ethinyloestradiol, Levonorgestrel, Phenprocoumon, Ritonavir, Saquinavir, and Tolbutamide. The right side lists dosage adjustment recommendations associated with each drug interaction, primarily stating "No dose adjustment" except for Ritonavir, which advises that coadministration is not recommended.*

FDA Label Image

Figure-9 (Sildenafil Fig 9)

A line graph showing change from baseline (meters) against weeks of study (4, 8, 12). The graph compares different dosage groups of Sildenafil (20 mg TID, 40 mg TID, 80 mg TID) and placebo, with data points and error bars illustrating variability in changes over time.*

FDA Label Image

Figure-7 (Sildenafil Figure 7)

A forest plot chart showing fold change and 90% confidence intervals in drug interactions with Sildenafil. It compares the area under the curve (AUC) and maximum concentration (Cmax) of various interacting drugs relative to Sildenafil alone. Recommendations for dose adjustments or coadministration are provided for each drug listed, including Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral contraceptives, Ritonavir, and Saquinavir.*

FDA Label Image

Str (Sildenafil Str)

Chemical structure diagram of the active ingredient Sildenafil, showing its molecular components and bonds. The structure includes a pyrazolopyrimidinone core with various functional groups attached, depicted with labeled atoms and bonds.*

* 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.