Tadalafil Tablet
Product Images NDC 65862-880

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 65862-880). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, 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

Figure 1: 6-minute Walk Distance (meters) Mean Change From Baseline, With 95% Confidence Intervals (Tadalafil Fig1)

A forest plot chart showing the mean differences in blood pressure measurements (systolic and diastolic) comparing tadalafil to placebo, including effects when coadministered with various drugs such as alcohol, alfuzosin, amlodipine, angiotensin II receptor blockers, doxazosin, tamsulosin, bendroflumethiazide, enalapril, and metoprolol. The horizontal axis represents the range from lower to higher relative to placebo.*

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Figure 2 (Tadalafil Fig2)

A chart illustrating fold change and 90% confidence intervals for various drugs coadministered with tadalafil. It shows changes in AUC and Cmax values relative to tadalafil alone, grouped by CYP3A inhibitors, CYP3A inducers, antacids, and H2 antagonists, with corresponding dosing recommendations such as dose adjustment, avoid use, or no dose adjustment.*

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Figure 3: Kaplan-meier Plot Of Time To Clinical Worsening (Tadalafil Fig3)

A forest plot chart depicting fold change and 90% confidence intervals (CI) for the effect of Tadalafil on various coadministered drugs, including CYP1A2, CYP2C9, CYP3A substrates, P-glycoprotein substrate, oral contraceptives, and NSAIDs. The chart shows fold change values relative to coadministered drug alone, with recommendations indicating no dose adjustment is necessary.*

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Package Label-principal Display Panel (20 mg (60 Tablets Bottle))

A line graph showing mean change from baseline in meters over 16 weeks comparing placebo (N=82) and Tadalafil 40 mg (N=79). The graph depicts greater improvement with Tadalafil than placebo at weeks 4, 8, 12, and 16, with statistical significance indicated at several time points (p-values ranging from 0.0152 to 0.0004). Error bars represent variability around the means.*

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Tadalafil Fig5

A forest plot showing placebo-adjusted mean changes in 6-minute walk distance (meters) for tadalafil 40 mg compared to placebo across various subject subgroups, including bosentan use, PAH etiology, baseline walk distance, gender, age, and WHO functional class, with 95% confidence intervals indicated.*

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Tadalafil Fig6

A Kaplan-Meier curve chart depicting the percentage of patients without clinical worsening over time in days. Three groups are shown: Tadalafil 40 mg, Tadalafil 20 mg, and Placebo, with the y-axis representing the percentage without clinical worsening and the x-axis representing the time to clinical worsening in days.*

FDA Label Image

Tadalafil Fig7

Label for Tadalafil Tablets USP 20 mg by Aurobindo Pharma Limited. The label states the product is for oral use and prescription only, with a package size of 60 tablets. It includes dosage information for two 20 mg tablets and storage instructions, featuring the NDC 65862-880.*

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Chemical Structure (Tadalafil Str)

Chemical structure of tadalafil illustrating its molecular framework and arrangement of atoms, including rings and functional groups.*

* 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.