Tadalafil Tablet, Film Coated
Product Images NDC 71610-567

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 71610-567). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, 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

Bottle Label 20 mg (71610 0567 04)

Label for Tadalafil 20 mg film-coated tablets by Aphena Pharma Solutions - Tennessee, LLC. The label includes storage instructions to keep between 20-25 degrees Celsius (68-77 degrees Fahrenheit), a note to see USP Controlled Room Temperature, and dispensing in a tight light-resistant container as defined by USP. It states the product is RX only and includes manufacturer and repackager information from Brookhaven, NY and Cookeville, TN respectively. Barcodes and lot/expiration details are also visible.*

FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

10 (Tadalafil Tablets Usp 1)

Chemical structure diagram of Tadalafil, the active ingredient shown in the product data. The structure depicts its molecular arrangement with rings and bonds as typical for this compound.*

FDA Label Image

10 (Tadalafil Tablets Usp 2)

Four line graphs displaying the difference in blood pressure readings (Tadalafil minus Placebo) over time in hours (0 to 96) for standing systolic, standing diastolic, supine systolic, and supine diastolic blood pressure. Each graph shows mean changes with error bars indicating variability.*

FDA Label Image

10 (Tadalafil Tablets Usp 3)

Two line graphs showing changes in systolic blood pressure (BP) over 24 hours post-dose. The top graph shows standing systolic BP, and the bottom graph shows supine systolic BP. Both compare Tadalafil 20 mg combined with doxazosin 8 mg versus placebo with doxazosin 8 mg, depicting BP changes in mmHg over time.*

FDA Label Image

10 (Tadalafil Tablets Usp 4)

A line graph depicting the change in systolic blood pressure (mmHg) over 12 hours after administration of tadalafil or placebo combined with doxazosin. The x-axis shows time after administration, and the y-axis shows systolic blood pressure values with multiple lines representing different dosing regimens of tadalafil and placebo with doxazosin.*

FDA Label Image

10 (Tadalafil Tablets Usp 5)

Pharmacokinetic graph showing plasma tadalafil concentration (mcg/L) over time (hours) for a single 20-mg dose, a single 5-mg dose, and once-daily 5-mg tadalafil following 5 consecutive days of administration. The graph includes error bars depicting variability at each time point.*

FDA Label Image

10 (Tadalafil Tablets Usp 6)

A line graph comparing change from baseline in IPSS Total Score over 12 weeks of treatment for Tadalafil 5 mg and placebo. The x-axis represents duration of treatment in weeks (0, 4, 8, 12) and the y-axis shows change from baseline in IPSS score, ranging from 0 to -6. Tadalafil shows a greater decrease in score over time compared to placebo, with statistical significance at p<0.01.*

FDA Label Image

10 (Tadalafil Tablets Usp 7)

A line graph depicting change from baseline in IPSS total score over 12 weeks of treatment comparing Tadalafil 5 mg and placebo. The x-axis shows duration of treatment in weeks, and the y-axis shows change in IPSS score. The Tadalafil group shows a greater decrease in IPSS score over time compared to placebo, with statistically significant differences at weeks 4 and 12 (p<0.01).*

FDA Label Image

10 (Tadalafil Tablets Usp 8)

A line graph showing the least squares mean change from baseline over 26 weeks of therapy, comparing Tadalafil/Finasteride with Placebo/Finasteride. The graph displays two lines marking the treatment difference at weeks 4, 12, and 26, with statistical significance annotations.*

FDA Label Image

10 (Tadalafil Tablets Usp 9)

A line graph depicting the change from baseline in IPSS total score over 12 weeks for Tadalafil 5 mg and placebo groups. The x-axis represents duration of treatment in weeks, and the y-axis shows the change from baseline in IPSS score. Two lines compare Tadalafil (solid circles) and placebo (open triangles), with Tadalafil showing a greater reduction over time.*

* 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.