Sildenafil Injection, Solution
Product Images NDC 55150-166

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 55150-166). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Eugia Us Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Figure 1: Kaplan-meier Plot Of Mortality By Sildenafil Dose (Sildenafil Fig1)

A line graph depicting estimated cumulative mortality rate (%) over time (years) for three dosage groups: High Dose, Medium Dose, and Low Dose. The High Dose group shows the highest increasing mortality rate, followed by Medium Dose, with Low Dose stable around 5%. The graph includes numbers at risk at different time points for each dose group.*

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Figure 2. Effects Of Other Drugs On Sildenafil Pharmacokinetics (Sildenafil Fig2)

A forest plot chart displaying fold change and 90% confidence intervals for pharmacokinetic parameters (AUC and Cmax) of Sildenafil when co-administered with various interacting drugs, including Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral Contraceptives, Ritonavir, and Saquinavir. The chart includes dosage adjustment recommendations, indicating no dose adjustment is needed for most drugs except caution with Ritonavir. The vertical line at 1 represents the reference level for Sildenafil alone.*

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Figure 3. Effects Of Sildenafil On Other Drugs (Sildenafil Fig3)

A chart depicting fold change and 90% confidence intervals for the interaction between sildenafil and various drugs, including acenocoumarol, aspirin, atorvastatin, bosentan, doxazosin, ethinylestradiol, levonorgestrel, phenprocoumon, ritonavir, saquinavir, and tolbutamide. The chart shows relative changes in INR AUC, INR Cmax, AUC, Cmax, and bleeding time, along with recommended dosage adjustments, mostly indicating no dose adjustment except for ritonavir where coadministration is not recommended.*

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Figure 4. Change From Baseline In 6-minute Walk Distance (meters) At Weeks 4, 8, And 12 In Study 1: Mean (95% Confidence Interval) (Sildenafil Fig4)

A line plot showing change from baseline in meters over a 12-week study period. The x-axis represents weeks 4, 8, and 12, while the y-axis shows the change from baseline in meters ranging from -20 to 80. Four groups are compared: Placebo, Sildenafil 40 mg TID, Sildenafil 20 mg TID, and Sildenafil 80 mg TID, each represented by different markers and error bars indicating variability.*

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Figure 5. Placebo-corrected Change From Baseline In 6-minute Walk Distance (meters) At Week 12 By Study Subpopulation In Study 1: Mean (95% Confidence Interval) (Sildenafil Fig5)

A horizontal forest plot showing placebo-corrected change in 6-minute walk distance (meters) for Sildenafil 20 mg TID versus placebo across various subgroups. Subgroups include baseline walk distance, etiology, pulmonary hypertension (PH) class, gender, age, mean pulmonary artery pressure (PAP), and pulmonary vascular resistance index (PVRI). Each subgroup is represented with effect size points and confidence intervals on both sides of the zero-effect line.*

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Figure 6. Kaplan-meier Plot Of Time (in Days) To Clinical Worsening Of Pah In Study 2 (Sildenafil Fig6)

A Kaplan-Meier survival curve chart comparing the percentage without a clinically worsening event over days from randomization between Sildenafil and placebo groups. The x-axis shows days from randomization up to 112 days, and the y-axis indicates the percentage without a clinically worsening event from 0 to 100%. Two curves represent placebo and Sildenafil, showing the Sildenafil group with a higher percentage over time.*

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Figure 7. Mean Change From Baseline In Six Minute Walk (meters) By Visit To Week 12 – Itt Population Sildenafil Protocol A1481244 (Sildenafil Fig7)

A line graph depicting the mean change from baseline in meters over a 12-week study period for three Sildenafil dosages: 1 mg TID, 5 mg TID, and 20 mg TID. The vertical axis shows change from baseline, while the horizontal axis represents weeks 4, 8, and 12. Error bars indicate standard error for each measurement.*

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Package Label-principal Display Panel (10 mg per 12.5 mL)

Sildenafil Injection label showing 10 mg per 12.5 mL (0.8 mg/mL) concentration for intravenous use. The sterile single-dose vial is for prescription use only. Label includes storage instructions, distributor AuroMedics Pharma LLC, and note that the vial stopper is not made with natural rubber latex.*

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Package Label-principal Display Panel (10 mg per 12.5 mL)

Packaging label for Sildenafil Injection 10 mg per 12.5 mL (0.8 mg/mL) sterile single-dose vial by Auromedics Pharma LLC. The label indicates intravenous use, storage instructions, and that the vial stopper does not contain natural rubber latex. The label includes NDC 55150-166-13 and states the product is made in India.*

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Sildenafil Citrate Chemical Structure (Sildenafil Str)

Chemical structure of Sildenafil Citrate, the active ingredient in Sildenafil injection, solution, 10 mg/12.5 mL, by Eugia US LLC. The diagram shows the molecular formula with labeled atoms and bonds characteristic of Sildenafil Citrate.*

* 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.