Tadalafil Tablet
Product Images NDC 71610-909

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 71610-909). 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

Label (71610 0909 36)

Tadalafil USP 5 mg oral tablets packaging label showing a quantity of 2940 tablets. Includes NDC 71610-909-36, storage instructions, and manufacturer information: Prinston Laboratories, Carrolton, NC, with packaging by Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN. Label indicates prescription use only.*

FDA Label Image

Aphena (Aphena)

FDA Label Image

F35596a7-figure-01 (F35596a7 Figure 01)

Chemical structure of tadalafil, the active ingredient in the TADALAFIL oral tablet by Aphena Pharma Solutions - Tennessee, LLC.*

FDA Label Image

F35596a7-figure-02 (F35596a7 Figure 02)

A set of four line graphs illustrating the difference in blood pressure measurements between tadalafil and placebo over time in hours. The graphs show changes in standing systolic, standing diastolic, supine systolic, and supine diastolic blood pressure with error bars at various time points up to 96 hours.*

FDA Label Image

F35596a7-figure-03 (F35596a7 Figure 03)

Two line graphs depicting changes in standing and supine systolic blood pressure (mmHg) over 24 hours post-dose, comparing tadalafil 20 mg with doxazosin 8 mg versus placebo with doxazosin 8 mg. The x-axis shows time in hours post-dose, and the y-axis shows blood pressure changes in mmHg.*

FDA Label Image

F35596a7-figure-04 (F35596a7 Figure 04)

A line graph depicting systolic blood pressure (mmHg) changes over 12 hours after administration of tadalafil or placebo combined with doxazosin. The x-axis shows time after administration, and the y-axis represents systolic blood pressure variation. Four treatment groups are plotted using different line styles and symbols.*

FDA Label Image

F35596a7-figure-05 (F35596a7 Figure 05)

A line graph showing plasma tadalafil concentration (µg/L) over time in hours for three dosing scenarios: single 20 mg dose, single 5 mg dose, and once-daily 5 mg dose after 5 consecutive days. Concentration declines over time in all scenarios with variations in peak levels and elimination patterns.*

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F35596a7-figure-06 (F35596a7 Figure 06)

Line graph showing change from baseline in IPSS Total Score over 12 weeks comparing Tadalafil tablets 5 mg with placebo. The x-axis represents duration of treatment in weeks, and the y-axis shows change from baseline in the score. Tadalafil demonstrates a greater reduction in score compared to placebo, with statistical significance noted at 12 weeks (p<0.01).*

FDA Label Image

F35596a7-figure-07 (F35596a7 Figure 07)

A line graph depicting change from baseline in IPSS Total Score over 12 weeks of treatment, comparing Tadalafil 5 mg tablets and placebo. The x-axis represents duration of treatment in weeks, and the y-axis shows change in score. Tadalafil shows a greater reduction over time, with statistically significant differences noted at week 4 and week 12 (p<0.01).*

FDA Label Image

F35596a7-figure-08 (F35596a7 Figure 08)

A line graph showing least squares mean change from baseline over 26 weeks of therapy, comparing Tadalafil/Finasteride and Placebo/Finasteride treatments. The X-axis represents weeks of therapy (0, 4, 12, 26), and the Y-axis represents least squares mean change from baseline, ranging from 0 to -7. Data points for both treatments decline over time, with specific values and statistical significance markers indicated.*

FDA Label Image

F35596a7-figure-09 (F35596a7 Figure 09)

A line graph showing the change from baseline in IPSS total score over 12 weeks of treatment. The graph compares Tadalafil tablets 5 mg and placebo. The vertical axis represents change in score, and the horizontal axis represents duration of treatment in weeks, with scores decreasing over time for both groups, more significantly for the Tadalafil group.*

* 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.