Sildenafil Tablet, Film Coated
Product Images NDC 35561-252

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 35561-252). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bostal 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.

FDA Label Image

100mg-1000s.jpg (100mg 1000s)

This is a description of a medication package of Sildenafil Tablets, USP manufactured by AustarPharma. The package contains 1000 tablets and is for prescription use only. The NDC number of the product is 35561-253-14.*

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100mg-30s.jpg (100mg 30s)

This is a prescription drug information label for Sildenafil tablets manufactured by AustarPharma. The label indicates that it contains 30 tablets and is for prescription use only. The NDC number provided is 35561-253-10.*

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25mg-1000s.jpg (25mg 1000s)

This is not readable.*

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25mg-30s.jpg (25mg 30s)

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50mg-1000s.jpg (50mg 1000s)

This text appears to be a prescription label for tablets, potentially containing the drug Sildenafil. The label includes details such as the quantity (1000 tablets), instructions for prescription use (Rx Only), manufacturer (AustarPharma), National Drug Code (NDC 35561-252-14), and the drug name (Sildenafil). It also seems to have some codes or identifiers related to the medication.*

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50mg-30s.jpg (50mg 30s)

Sildenafil tablets, USP, are prescribed for various health issues. This medication is available in a pack of 30 tablets under the brand AuStarPharma. The National Drug Code (NDC) for this product is 35561-252-10.*

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Figure1.jpg (Figure1)

This information provides data on the mean change from baseline in sitting systolic blood pressure in healthy volunteers.*

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Figure2.jpg (Figure2)

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Figure3.jpg (Figure3)

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Figure4.jpg (Figure4)

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Figure5.jpg (Figure5)

This is a description of a figure showing the average sildenafil plasma concentrations in healthy male volunteers.*

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Figure6.jpg (Figure6)

This text discusses the effect of Sildenafil on the maintenance of erection compared to a placebo, measured by baseline score. The study compares the efficacy of Sildenafil and Placebo in maintaining erections.*

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Figure7.jpg (Figure7)

This text provides data on the percentage of patients reporting an improvement in erections after a certain treatment. The overall treatment had a significant effect with a p-value of less than 0.0001. The text also includes information on percentages related to the treatment.*

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Structure.jpg (Structure)

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Table-2.jpg (Table 2)

This text provides a breakdown of adverse reactions reported by patients treated with Sildenafil in comparison to those given a placebo in flexible-dose Phase II/III studies. The table lists common adverse reactions, with the percentage of patients experiencing each reaction. Some of the adverse reactions observed with Sildenafil include headache, flushing, dyspepsia, nasal congestion, abnormal vision, back pain, dizziness, and rash. The text also mentions that abnormal vision with Sildenafil was generally mild and transient, with symptoms such as color tinge to vision, increased sensitivity to light, or blurred vision. Only one patient discontinued treatment due to abnormal vision in these studies.*

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Table-3.jpg (Table 3)

This is a table displaying hemodynamic data in patients with stable ischemic heart disease after the intravenous administration of 40 mg of Sildenafil. The data includes measurements such as pulmonary artery occlusion pressure (PAOP), mean pulmonary artery pressure (PAP), mean right atrial pressure (RAP), systolic and diastolic systemic arterial pressure (SAP), cardiac output, heart rate, and more. The table shows values for both baseline and after exercise, providing insights into the effects of Sildenafil on hemodynamics in these patients.*

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Table1.jpg (Table1)

This is a table showing the adverse reactions reported by patients treated with sildenafil in fixed-dose phase I/III studies. The table includes the percentages of patients experiencing common side effects such as headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash. The data show the comparison of adverse reactions reported for different doses of sildenafil (25mg, 50mg, and 100mg) and placebo. Overall, headaches were the most frequent adverse reaction reported, followed by flushing and dyspepsia. Abnormal vision was also noted but was described as mild to moderate in severity and transient.*

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