Sildenafil For Suspension
Product Images NDC 69543-419

Product Visual Gallery

This gallery contains 26 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 69543-419). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Virtus Pharmaceuticals, 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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Fig1 (Fig1)

An instructional diagram showing a bottle containing a liquid suspension and a graduated syringe marked with measurement units, indicating a single dose withdrawal for oral administration.*

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Fig10 (Fig10)

A forest plot chart showing placebo-corrected changes in 6-minute walk distance in meters for sildenafil 20 mg TID across subgroups including baseline walk distance, etiology, pulmonary hypertension criteria, gender, age, mean pulmonary artery pressure (PAP), and pulmonary vascular resistance index (PVRI). Each subgroup compares sildenafil versus placebo with confidence intervals.*

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Fig11 (Fig11)

A survival curve chart showing the percentage of subjects without a clinically worsening event over time, comparing sildenafil and placebo groups. The x-axis represents days from randomization up to 112 days, while the y-axis shows the percentage without worsening events from 0% to 100%. The sildenafil group maintains a higher percentage over time compared to placebo.*

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Fig12 (Fig12)

A line graph displaying mean change from baseline in meters over study weeks for sildenafil oral suspension at doses of 1 mg TID, 5 mg TID, and 20 mg TID. The x-axis shows weeks 4, 8, and 12, and the y-axis shows change from baseline with error bars representing standard error for each dose group at each time point.*

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Fig5 (Fig5)

Illustration showing steps to open a bottle of sildenafil oral suspension. The first step depicts removing a protective cap by pulling upward. The second step shows twisting the bottle cap to open it. Both images emphasize the correct handling of the bottle closure.*

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Fig6 (Fig6)

A line graph showing estimated cumulative mortality rate (%) over time in years for three dose groups labeled High Dose, Medium Dose, and Low Dose. The graph includes a stepwise increase in mortality for each group, with High Dose showing the highest cumulative mortality, followed by Medium Dose, and then Low Dose with the lowest. The number at risk for each group is displayed above the graph at various time points.*

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Fig7 (Fig7)

A chart showing the fold change and 90% confidence interval of various drugs interacting with sildenafil, measuring AUC and Cmax relative to sildenafil alone. It includes a recommendation column indicating dose adjustments or coadministration advice for drugs like Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral Contraceptives, Ritonavir, and Saquinavir.*

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Fig8 (Fig8)

A forest plot chart depicting drug interactions with sildenafil, showing fold change and 90% confidence intervals for various pharmacokinetic parameters such as AUC and Cmax. The chart lists interacting drugs on the left, with corresponding dose adjustment recommendations on the right. The x-axis represents fold change relative to the interacting drug alone, with a vertical reference line at 1. Notes include specific sildenafil doses for doxazosin and study-based explanations for certain recommendations.*

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Fig9 (Fig9)

A line graph depicting change from baseline in a measured parameter (in meters) over 12 weeks of study. The x-axis shows weeks 4, 8, and 12, while the y-axis measures change from baseline ranging from -20 to 80 meters. Data points represent four groups: placebo, sildenafil 20mg TID, sildenafil 40mg TID, and sildenafil 80mg TID, each with error bars indicating variability.*

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Figa (Figa)

An instructional diagram illustrating components of the sildenafil oral suspension packaging and dosing syringe. It labels a bottle of oral suspension with a cap and syringe adaptor, and a dosing syringe showing the tip, barrel with volume markings (0.5 mL and 2 mL), and plunger.*

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Figb (Figb)

An instructional illustration showing steps for preparing an oral suspension bottle. On the left, a hand is shown shaking the bottle with arrows indicating rocking and vertical movement. In the center, a stopwatch indicates a 5-second timing. On the right, a hand is shown pressing down and turning the bottle cap to open it.*

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Figc (Figc)

An instructional line drawing showing hands holding a bottle with a dosing syringe inserted into the bottle's top. An arrow indicates pushing the syringe straight down into the bottle, illustrating how to attach or use the syringe for oral suspension dosing.*

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Figd (Figd)

An instructional illustration showing how to withdraw liquid from an inverted bottle into a syringe marked with 0.5 mL and 2 mL graduations. A hand holds the bottle upside down while drawing medication into the syringe, demonstrating proper technique for liquid measurement and administration.*

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Fige (Fige)

An illustration showing a syringe inserted into the top of a bottle, with an upward arrow indicating the syringe plunger should be pulled up. The image likely demonstrates how to draw medication from the bottle.*

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Figf (Figf)

An instructional illustration showing the administration of oral suspension medication with a syringe into a person's mouth. The syringe is positioned at the lips for precise dosing.*

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Figg (Figg)

An instructional line drawing showing a water tap running water into two oral syringes, one graduated to 0.5 mL and the other to 2 mL, illustrating proper syringe rinsing or cleaning procedure.*

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Sildenafil-spl-carton (Sildenafil Spl Carton)

Label for sildenafil for oral suspension 10 mg/mL by Virtus Pharmaceuticals, LLC. The label includes directions for reconstitution to 112 mL total volume, storage instructions, and dosage information. The oral suspension is grape flavored and for oral use only.*

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Sildenafil-spl-label (Sildenafil Spl Label)

Label for sildenafil oral suspension, 10 mg/mL strength, distributed by Virtus Pharmaceuticals, LLC. The label states the product is for oral use only, with a volume of 112 mL after reconstitution. Storage instructions before and after reconstitution are provided, along with a notice to shake well before use. The suspension is grape flavored and the label includes the NDC 69543-419-72 barcode and company logo.*

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Sildinafil-spl-figu2 (Sildinafil Spl Figu2)

An instructional diagram showing how to prepare an oral suspension bottle. Steps include pressing down and turning the cap to open, shaking the bottle vertically and horizontally to mix contents, and timing 15 seconds with a stopwatch for thorough mixing.*

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Sildinafil-spl-figu3 (Sildinafil Spl Figu3)

An instructional diagram showing a graduated cylinder, a bottle with a cap, and a syringe marked with measurement lines from 0 to 10 mL. The syringe is indicated as requested in a single unit (x1), suggesting measuring or dosing instructions for oral suspension.*

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Sildinafil-spl-figu4 (Sildinafil Spl Figu4)

Instructional illustration showing how to prepare sildenafil oral suspension by shaking the bottle. The first image shows pressing down and turning the cap to open. The second image demonstrates holding the bottle and shaking it up and down. The third image depicts a stopwatch indicating timing, suggesting the need to wait or shake for a certain duration.*

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Sildinafil-spl-image1 (Sildinafil Spl Image1)

A data table comparing placebo and sildenafil 20 mg three times a day, showing measurements for mPAP, PVR, SVR, RAP, CO, and HR with values indicating changes under each treatment group for clinical study participants.*

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Sildinafil-spl-image2 (Sildinafil Spl Image2)

A data table comparing clinical worsening events between placebo and sildenafil groups in a study. The table lists the number of subjects experiencing first events and all events across categories including death, lung transplantation, hospitalization due to pulmonary arterial hypertension (PAH), clinical deterioration requiring dose changes or medication initiation, and overall proportion worsened with 95% confidence intervals.*

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Sildinafil-spl-image3 (Sildinafil Spl Image3)

A table presenting package configuration and strength information for sildenafil oral suspension. It specifies the product as powder for oral suspension in a 125 mL amber glass bottle, with a strength of 10 mg/mL when reconstituted and NDC 69543-419-72.*

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Stru (Structure)

Chemical structure of sildenafil, the active ingredient in the product sildenafil oral suspension 10 mg/mL by Virtus Pharmaceuticals. The diagram shows the molecule's arrangement including rings, bonds, and functional groups characteristic of sildenafil.*

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Virtus-logo (Virtus Logo)

* 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.