Tadalafil Tablet
Product Images NDC 82868-028

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 82868-028). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Northwind Health Company, 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

Label (82868 028 15 Rev A 11 23)

Label for Tadalafil 20 mg tablets, USP, oral tablets supplied in a package of 15 tablets. The label includes storage instructions, dosage cautions, and the NDC number 82868-028-15. Manufactured and repackaged by Northwind Pharmaceuticals and later repackaged by Northwind Health Company, LLC.*

FDA Label Image

Figure 1 (Tadalafil Fig1)

A forest plot showing the mean differences in blood pressure (systolic and diastolic) between tadalafil and placebo under various conditions and coadministered drugs. The chart includes confidence intervals and compares standing, supine, and ambulatory measurements for 20 mg and 10 mg tadalafil doses with multiple concomitant medications.*

FDA Label Image

Figure 2 (Tadalafil Fig2)

A chart showing fold change and 90% confidence intervals for various coadministered drugs with tadalafil, including CYP3A inhibitors, CYP3A inducers, antacids, and H2 antagonists. The chart compares changes in area under the curve (AUC) and maximum concentration (Cmax) relative to tadalafil alone, with dose adjustment or avoidance recommendations listed.*

FDA Label Image

Figure 3 (Tadalafil Fig3)

A forest plot showing fold changes and 90% confidence intervals for various pharmacokinetic parameters (AUC, Cmax) and bleeding time when Tadalafil is coadministered with different drugs. The chart indicates relative changes compared to each coadministered drug alone, with a recommendation column stating no dose adjustment needed.*

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Figure 4 (Tadalafil Fig4)

A line graph showing mean change from baseline in meters over 16 weeks comparing Tadalafil 40 mg and placebo. The graph plots weeks on the horizontal axis and mean change from baseline on the vertical axis. Data points for Tadalafil show increasing improvement over time with statistical significance indicated at weeks 8, 12, and 16, while placebo shows minimal change.*

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Figure 5 (Tadalafil Fig5)

A horizontal forest plot chart showing placebo-adjusted mean changes in 6-minute walk distance (meters) with Tadalafil 40 mg, including 95% confidence intervals. The chart compares various subject groups based on factors such as Bosentan use, PAH etiology, baseline walk distance, gender, age, and WHO functional class. The number of subjects in placebo and tadalafil groups is listed, with changes quantified on a scale from -100 to 200 meters.*

FDA Label Image

Figure 6 (Tadalafil Fig6)

A Kaplan-Meier curve graph depicting the percentage of patients without clinical worsening over time in days. The graph compares three groups: Tadalafil 40 mg, Tadalafil 20 mg, and placebo, showing time to clinical worsening on the x-axis and percentage without worsening on the y-axis.*

FDA Label Image

Chemical Structure (Tadalafil Str)

Chemical structure of the active ingredient Tadalafil, showing the molecular configuration including fused rings and functional groups typical of this compound.*

* 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.