Sildenafil Tablet, Film Coated
Product Images NDC 0904-6671

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 0904-6671). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Major Pharmaceuticals, 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

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SILDENAFIL 20 mg film-coated tablets label from Major Pharmaceuticals. The front label includes the product name, strength, and quantity of 30 tablets in a unit dose package. It features dispensing instructions for pharmacists and storage conditions. Manufactured by Torrent Pharmaceuticals Ltd., India, and Torrent Pharma Inc., USA, and distributed by Major Pharmaceuticals in Livonia, MI.*

FDA Label Image

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A line chart depicting the estimated cumulative mortality rate (%) over 5 years according to three dose groups labeled as High dose, Medium dose, and Low dose. The x-axis represents time in years, and the y-axis shows the mortality rate percentage. The chart includes the number of subjects at risk at multiple time points for each dose group.*

FDA Label Image

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Chemical structure diagram of sildenafil, showing its molecular composition and arrangement of atoms, with clearly visible rings and functional groups consistent with the active ingredient sildenafil.*

FDA Label Image

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A forest plot displaying fold change and 90% confidence intervals for various interacting drugs relative to Sildenafil alone, with a vertical line at 1. Drugs listed include Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral Contraceptives, Ritonavir, and Saquinavir. Recommendations for each drug regarding dose adjustment or coadministration are shown on the right side.*

FDA Label Image

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A forest plot chart depicting the fold change and 90% confidence intervals in pharmacokinetic parameters when sildenafil is coadministered with various interacting drugs. The x-axis shows change relative to the interacting drug alone, ranging from 0.5 to 2.0. The y-axis lists interacting drugs including Acenocoumarol, Aspirin, Atorvastatin, Bosentan, Doxazosin (three dosages), ethinylestradiol, levonorgestrel, phenprocoumon, ritonavir, saquinavir, and toltubamide. Recommendations on dose adjustment or coadministration are provided alongside, mostly indicating no dose adjustments except for ritonavir (coadministration not recommended). The plot illustrates pharmacokinetic interaction severity for human prescription drug Sildenafil tablets, 20 mg, by Major Pharmaceuticals.*

FDA Label Image

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A line graph showing change from baseline in meters over 12 weeks of study for different Sildenafil dosages and placebo. The x-axis represents Week 4, Week 8, and Week 12, while the y-axis shows change from baseline values. The graph includes data points with error bars for Placebo, Sildenafil 20 mg TID, Sildenafil 40 mg TID, and Sildenafil 80 mg TID, indicating comparative efficacy over time.*

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A forest plot chart showing placebo-corrected changes in 6-minute walk distance in meters for Sildenafil 20 mg taken three times daily across various subgroups. The subgroups include baseline walk distance, etiology, pulmonary hypertension criteria, gender, age, mean pulmonary arterial pressure, and pulmonary vascular resistance index, each with sample sizes for placebo and Sildenafil groups and plotted confidence intervals.*

FDA Label Image

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A Kaplan-Meier plot illustrating time in days to clinical worsening of PAS in Study 2. The x-axis shows days from randomization, while the y-axis indicates the percentage without a clinically worsening event. Two curves compare placebo and sildenafil treatments over approximately 112 days.*

FDA Label Image

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A line graph titled 'Mean Change from Baseline in Six Minute Walk (meters) by Visit to Week 12 – ITT Population Sildenafil Protocol A1481244.' The x-axis shows study weeks 4, 8, and 12, while the y-axis represents change from baseline in meters, ranging from -10 to 70. The plot compares mean changes with standard error bars for three Sildenafil dosage groups: 1 mg TID, 5 mg TID, and 20 mg TID, showing increasing improvement over time across all doses.*

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FDA Label Image

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* 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.