Sildenafil Tablet, Film Coated
Product Images NDC 72865-105

9 FDA label images from Xlcare Pharmaceuticals, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 72865-105). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Xlcare 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

90scount.jpg (90scount)

90scount.jpg (90scount)
The label for Sildenafil Tablets 20 mg by XLcare Pharmaceuticals, Inc. It indicates the product is a film-coated oral tablet, with a package size of 90 tablets. The label includes storage instructions, dispensing information, manufacturer details, and cautions for the pharmacist to provide the patient information sheet. The NDC code 72865-105-90 is printed beneath the company name.*
FDA Label Image

Figure1 (Figure1)

Figure1 (Figure1)
A Kaplan-Meier survival curve chart showing estimated cumulative mortality rates over time for three dosage groups labeled High dose, Medium dose, and Low dose. The y-axis represents estimated cumulative mortality rate (%) and the x-axis represents time in years. Numbers at risk for each group are displayed at intervals along the top.*
FDA Label Image

Figure2 (Figure2)

Figure2 (Figure2)
A chart showing fold change and 90% confidence intervals (CI) for drug interaction effects on the pharmacokinetics of Sildenafil. It compares the area under the curve (AUC) and maximum concentration (Cmax) of Sildenafil alone versus with various interacting drugs, such as Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral Contraceptives, Ritonavir, and Saquinavir, along with dose adjustment recommendations.*
FDA Label Image

Figure3 (Figure3)

Figure3 (Figure3)
A chart titled 'Fold Change and 90% CI' comparing the interaction effects of Sildenafil with various drugs. The x-axis shows change relative to the interacting drug alone, ranging from 0.5 to 2. The chart lists drugs on the y-axis with fold change and confidence intervals depicted as points with error bars, alongside dosing adjustment recommendations such as 'No dose adjustment' or 'Coadministration not recommended.' Notes below clarify dosage specifics and study references regarding Sildenafil interactions.*
FDA Label Image

Figure4 (Figure4)

Figure4 (Figure4)
A line graph comparing the change from baseline in mean values over weeks 4, 8, and 12 for three groups: Placebo, Sildenafil 40 mg three times daily (TID), and Sildenafil 80 mg TID. The x-axis shows the week of study; the y-axis represents change from baseline in mean values. Error bars indicate variability for each data point.*
FDA Label Image

Figure5 (Figure5)

Figure5 (Figure5)
A forest plot comparing placebo and Sildenafil 20 mg TID for change in 6-minute walk distance across various subgroups. Subgroups include baseline walk distance, etiology, pulmonary hypertension criteria, gender, age, mean pulmonary arterial pressure, and PVRI. The plot shows placebo-corrected effects with confidence intervals for each subgroup.*
FDA Label Image

Figure6 (Figure6)

Figure6 (Figure6)
A line graph depicting the percentage of subjects without a clinically worsening event over days from randomization, comparing Sildenafil and Placebo groups. The graph shows time on the x-axis (0 to 112 days) and percentage on the y-axis, with Sildenafil represented by a dashed line and Placebo by a solid line.*
FDA Label Image

Figure7 (Figure7)

Figure7 (Figure7)
A line plot showing mean change from baseline (in meters) over weeks 4, 8, and 12 of study. It compares three Sildenafil groups: 1 mg TID, 5 mg TID, and 20 mg TID, with error bars indicating standard error for each treatment at each visit.*
FDA Label Image

Structure (Structure)

Structure (Structure)
Chemical structure of Sildenafil, showing its detailed molecular composition with functional groups and ring systems consistent with the active ingredient structure.*

* 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.