Sildenafil For Suspension
Product Images NDC 69543-419

View Photos of Packaging, Regulatory Labels, and Product Appearance

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)

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Fig10 (Fig10)

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Fig12 (Fig12)

Fig12 (Fig12)
This is a graph that shows the mean change from baseline in meters (+/- standard error) for each treatment at each visit up to week 12. The treatments compared are Sildenafil ImgTID, Sildenafil SmgTID, and Sildenafil 20mg TID. The X-axis represents the week of the study with visits at week 4, week 8, and week 12.*
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Fig7 (Fig7)
This is a drug interaction chart that provides recommendations for drug dosage adjustments. The chart includes different drugs such as Atorvastatin, Azithromycin, Cimetidine, Erythromycin, Maslox, Oral contraceptives, Ritonavir, and Saquinavir. The graph also includes a line graph that is used to compare the effectiveness of the drugs concerning Sildenafil alone. The chart also gives additional information such as 90% confidence interval, recommended dosage adjustment, and the benefit of using Sildenafil in combination with bosentan therapy.*
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Fig8 (Fig8)

Fig8 (Fig8)
This is a list of drugs that interact with Acenocoumarol. The table gives details on the impact of each interaction on the drug's INR AUC, INR Cmax, BT, AuC, Cmax and recommends if there is any need for dose adjustment. Doxazosin 1, 2 and 3, when coadministered with 25 mg, 50 mg, and 100 mg sildenafil respectively, showed a 95% fold change and 90% CI. The recommendation section suggests no dose adjustment for most of the interactions, except for coadministration with Ritonavirt where it is not recommended.*
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Fig9 (Fig9)

Fig9 (Fig9)
This is a table illustrating the change from baseline in meters for a study conducted over 12 weeks with different treatment groups. It includes four weeks, eight weeks, and twelve weeks of the study. The key explains the treatment groups - Sildenafil 40mg TID, placebo, Sildenafil 80mg TID, and Sildenafil 20mg TD.*
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Figa (Figa)

Figa (Figa)
This appears to be a diagram depicting a syringe adaptor and a bottle of oral suspension medication. The adaptor is designed to fit onto the end of a syringe and into the bottle's opening, allowing the medication to be drawn into the syringe for administration. The image also includes a plunger for the syringe.*
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Figb (Figb)

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Figg (Figg)

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Sildenafil-spl-carton (Sildenafil Spl Carton)

Sildenafil-spl-carton (Sildenafil Spl Carton)
This is a description of a sildenafil oral suspension medication. The product has a National Drug Code (NDC) of 69543.41872 and 69543-419.72, and is available in 10mg/mL concentration. Each bottle of the suspension contains 10 doses. It is recommended for oral use only and should be shaken well before each use. The medication has a grape flavor. The text does not provide any additional information about the product or its use.*
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Sildenafil-spl-label (Sildenafil Spl Label)

Sildenafil-spl-label (Sildenafil Spl Label)
This is a prescription drug called Sildenafil, available in oral suspension form. The bottle should be shaken well before use and should be stored below 30°C (86°F) or in the refrigerator at 2°C to 8°C (36°F to 46°F) after reconstitution. Each 112 mL of the suspension contains 10 mg of Sildenafil (as citrate) when reconstituted with 92 L water. The recommended dosage should be followed as per the prescribing information provided. The drug can only be used orally and it should be discarded 60 days after reconstitution. This drug is distributed by Virtus Pharmaceuticals LLC and the contact number for the company is 1-838-846-3503. The drug is grape-flavored and the expiry date is not available from the given text.*
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Sildinafil-spl-figu2 (Sildinafil Spl Figu2)

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Sildinafil-spl-figu3 (Sildinafil Spl Figu3)

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Sildinafil-spl-figu4 (Sildinafil Spl Figu4)

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Sildinafil-spl-image1 (Sildinafil Spl Image1)

Sildinafil-spl-image1 (Sildinafil Spl Image1)
This appears to be a medical report or chart concerning the administration of sildenafil to treat high blood pressure in the lungs. Information includes dosages, blood pressure readings, and heart rate.*
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Sildinafil-spl-image2 (Sildinafil Spl Image2)

Sildinafil-spl-image2 (Sildinafil Spl Image2)
This text seems to be a table with information about clinical worsening events in patients treated with Sildenafil and Bosentan for Pulmonary Arterial Hypertension (PAH). The table displays the number of participants who experienced clinical worsening events as their first event or any event. The clinical worsening events documented include death, lung transplantation, and hospitalization due to PAH. Additionally, the table provides information on clinical deterioration resulting from a change of Egospostenc dose or termination of Bosentan. The proportion of participants who worsened is given, along with a 95% confidence interval. Overall, the text provides statistical data related to PAH treatment with Sildenafil and Bosentan.*
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Sildinafil-spl-image3 (Sildinafil Spl Image3)

Sildinafil-spl-image3 (Sildinafil Spl Image3)
This is a package configuration for a 125 mL Amber Glass Bottle containing powder for oral suspension with a strength of 10 mg/mL (when reconstituted) and an NDC code of 69543-419-72.*
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Stru (Structure)

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* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.