Sildenafil
Product Images NDC 53002-2719

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 53002-2719). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Rpk 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

Label Image (Lbl530022719)

Sildenafil 20 mg tablets packaging label from RPK Pharmaceuticals, Inc. The label states the product contains 30 tablets. It includes directions to take as directed and the note Rx only. Additional details include lot number and expiration date fields, with placeholders for patient and prescriber names. The label is predominantly black and white with some red text.*

FDA Label Image

Figure-10 (Sildenafil Fig 10)

A forest plot depicting the placebo-corrected change in 6-Minute Walk Distance (m) for Sildenafil 20 mg taken three times daily versus placebo. The horizontal axis represents change in meters, with subgroups by baseline walk distance, etiology, pulmonary hypertension criteria, gender, age, mean pulmonary arterial pressure, and pulmonary vascular resistance index. Each subgroup has a diamond marker with confidence intervals showing relative treatment effects.*

FDA Label Image

Figure-11 (Sildenafil Fig 11)

A survival curve chart showing the percentage of subjects without a clinically worsening event over time (days from randomization). The chart compares two groups, Placebo and Sildenafil, with Placebo represented by a solid line and Sildenafil by a dashed line, indicating trends in clinical outcomes over a period of approximately 112 days.*

FDA Label Image

Fig-12 (Sildenafil Fig 12)

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

FDA Label Image

Fig-6 (Sildenafil Fig 6)

A cumulative mortality rate chart illustrating estimated mortality percentages over a period of five years. The graph compares three groups labeled as High dose, Medium dose, and Low dose, with mortality rates increasing most steeply in the High dose group, less in the Medium dose, and lowest in the Low dose. The number of subjects at risk is listed for each group at various time points.*

FDA Label Image

Fig-8 (Sildenafil Fig 8)

A fold change and 90% confidence interval chart showing changes in various pharmacokinetic parameters (INR AUC, INR Cmax, bleeding time, AUC, Cmax) for different interacting drugs with sildenafil. It includes drug names and dosing details, notably doxazosin at multiple doses, and provides dosage adjustment recommendations, mostly indicating no dose adjustment, with exceptions noted for ritonavir and bosentan.*

FDA Label Image

Figure-9 (Sildenafil Fig 9)

A line graph depicting change from baseline (meters) over a 12-week study period. Data points are shown for placebo and three Sildenafil doses (20 mg, 40 mg, and 80 mg) taken three times daily (TID). The graph compares these groups at weeks 4, 8, and 12 with vertical error bars indicating variability.*

FDA Label Image

Figure-7 (Sildenafil Figure 7)

A forest plot illustrating fold changes with 90% confidence intervals for the area under the curve (AUC) and peak concentration (Cmax) of Sildenafil when coadministered with various interacting drugs, including Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral Contraceptives, Ritonavir, and Saquinavir. Recommendations for dose adjustment are provided alongside each drug.*

FDA Label Image

Str (Sildenafil Str)

Chemical structure of Sildenafil showing its molecular framework with various functional groups, including piperazine and sulfonyl components, depicted in a two-dimensional formula.*

* 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.