Sildenafil Tablet, Film Coated
Product Images NDC 65862-691

11 FDA label images from Aurobindo Pharma Limited · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 65862-691). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, 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

Figure 1 (Sildenafil Fig1)

Figure 1 (Sildenafil Fig1)
A line graph showing mean change from baseline in sitting systolic blood pressure over 24 hours post dose in healthy volunteers. The graph compares two groups: Sildenafil 100 mg and Placebo, with systolic blood pressure changes on the y-axis and time post-dose (hours) on the x-axis.*
FDA Label Image

Package Label-principal Display Panel (100 mg (30Tablets Bottle))

Package Label-principal Display Panel (100 mg (30Tablets Bottle))
Label for Sildenafil Tablets, USP 100 mg film-coated tablets by Aurobindo Pharma Limited. The label notes each tablet contains sildenafil citrate USP equivalent to 100 mg sildenafil. The package contains 30 tablets, distributed by Aurobindo Pharma USA, Inc. with storage instructions and a coding area for batch and expiry details. NDC 65862-691-30 is visible on the label.*
FDA Label Image

Figure 2 (Sildenafil Fig2)

Figure 2 (Sildenafil Fig2)
A line graph titled 'Mean Standing Systolic Blood Pressure Change from Baseline' showing the change in systolic blood pressure (SBP, mmHg) over time postdose (hours) up to 8 hours. Two lines compare Doxazosin with Placebo and Doxazosin with Sildenafil 25 mg, indicating changes in SBP at several time points.*
FDA Label Image

Figure 3 (Sildenafil Fig3)

Figure 3 (Sildenafil Fig3)
Line graph comparing mean standing systolic blood pressure change from baseline over 8 hours postdose between two groups: Doxazosin + Placebo and Doxazosin + Sildenafil 50 mg. The y-axis shows change in SBP in mmHg, and the x-axis shows time in hours postdose. Data points for both groups fluctuate around zero change, with the Doxazosin + Sildenafil 50 mg group generally showing a greater reduction in systolic blood pressure.*
FDA Label Image

Figure 4 (Sildenafil Fig4)

Figure 4 (Sildenafil Fig4)
A line graph showing mean standing systolic blood pressure change from baseline over 8 hours after dosing. The lines compare two groups: one receiving Doxazosin plus Sildenafil 100 mg, and the other receiving Doxazosin plus Placebo. The y-axis measures pressure change in mmHg, while the x-axis represents time in hours after dosing.*
FDA Label Image

Figure 5 (Sildenafil Fig5)

Figure 5 (Sildenafil Fig5)
A line graph showing mean plasma concentrations of Sildenafil (in ng/mL) over 24 hours post dose in healthy male volunteers. The x-axis represents time in hours post dose, and the y-axis shows plasma concentration levels. The graph includes data for a commercial tablet formulation, indicating peak concentration around 1 to 2 hours after dosing followed by a gradual decline.*
FDA Label Image

Figure 6. Effect Of Sildenafil And Placebo On Maintenance Of Erection By Baseline Score (Sildenafil Fig6)

Figure 6. Effect Of Sildenafil And Placebo On Maintenance Of Erection By Baseline Score (Sildenafil Fig6)
Two bar graphs comparing the effect of Sildenafil and placebo on the maintenance of erection by baseline score. The x-axis shows baseline scores from 0 to 5; the y-axis displays the percentage of patients at endpoint, ranging from 0% to 80%. Each graph uses stacked bars representing scores 0 through 5, differentiated by shading. The first graph shows data for Sildenafil, the second for placebo, illustrating differences in patient response by baseline score.*
FDA Label Image

Sildenafile Fig 7 (Sildenafil Fig7)

Sildenafile Fig 7 (Sildenafil Fig7)
A vertical bar chart illustrating the percentage of patients reporting improvement in erections across four treatment groups: Placebo, Sildenafil 25 mg, Sildenafil 50 mg, and Sildenafil 100 mg. The chart shows increasing improvement with higher Sildenafil doses, with percentages labeled above each bar.*
FDA Label Image

Package Label-principal Display Panel (25 mg (30 Tablets Bottle))

Package Label-principal Display Panel (25 mg (30 Tablets Bottle))
Sildenafil Tablets USP 25 mg film-coated tablets label. The package contains 30 tablets. Distributed by Aurobindo Pharma USA, Inc., made in India. Instructions include storage between 20° to 25°C and dispensing in tight containers. The label features a barcode and a designated coding area for batch and expiry information.*
FDA Label Image

Package Label-principal Display Panel (50 mg (30 Tablets Bottle))

Package Label-principal Display Panel (50 mg (30 Tablets Bottle))
Sildenafil Tablets, USP 50 mg film-coated tablets packaging label by Aurobindo Pharma. The label states it contains 30 tablets with each film-coated tablet containing sildenafil citrate USP equivalent to 50 mg sildenafil. It includes storage instructions and distributor information for Aurobindo Pharma USA, Inc., East Windsor, NJ. The label also displays the NDC 65862-690-30, barcode, and dosage guidance to see prescribing information.*
FDA Label Image

Structure (Sildenafil Str)

Structure (Sildenafil Str)
Chemical structure of the active ingredient Sildenafil, showing its molecular arrangement including heterocyclic rings, side chains, and functional groups as typically depicted in pharmaceutical labeling.*

* 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.