Tadalafil Tablet, Film Coated
Product Images NDC 80425-0443

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 80425-0443). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Advanced Rx Of 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

Tadalafil 20mg #7 (Tadalafil 20mg 80425 0443 01)

Tadalafil 20 mg tablet packaging label displays the drug's proprietary name, strength, and dosage form as film-coated tablets. It is labeled for prescription use only, comparing it to Cialis. The label includes storage instructions, a barcode, the NDC 80425-0443-01, and manufacturer Advanced Rx of Tennessee, LLC, Nashville, TN. The lot number and expiration date are partially obscured.*

FDA Label Image

Figure 5 (F005)

A line graph showing the change from baseline in IPSS total score over 12 weeks for Tadalafil Tablets 5 mg versus placebo. The graph plots the duration of treatment in weeks on the x-axis and change in score on the y-axis, illustrating greater score reductions for Tadalafil compared to placebo throughout the treatment period.*

FDA Label Image

Figure 6 (F006)

A line graph showing change from baseline in IPSS total score over 12 weeks of treatment. The graph compares Tadalafil 5 mg tablets to placebo, with data points at 0, 2, 4, 8, and 12 weeks. The graph indicates a greater reduction in IPSS score for Tadalafil 5 mg compared to placebo, with statistical significance noted at 12 weeks.*

FDA Label Image

Figure 7 (F007)

A line graph showing least squares mean change from baseline over 26 weeks of therapy comparing Tadalafil/Finasteride and Placebo/Finasteride. The x-axis represents weeks of therapy (0, 4, 12, 26) and the y-axis measures change from baseline. Data points with statistical significance markers (p<0.001, p<0.05) are displayed for both treatment groups across time.*

FDA Label Image

Figure 8 (F008)

This line graph compares the change from baseline in IPSS total score over 12 weeks of treatment between Tadalafil 5 mg tablets and placebo. The x-axis shows duration of treatment in weeks, and the y-axis shows change from baseline IPSS scores, with Tadalafil showing a greater decrease than placebo over time. A statistically significant difference at 12 weeks (p<0.01) is indicated.*

FDA Label Image

Figure1 (Figure1)

A set of four line graphs showing the difference in blood pressure between Tadalafil and placebo over time, up to 96 hours. Graphs display standing systolic, standing diastolic, supine systolic, and supine diastolic blood pressure changes in mmHg, with time on the x-axis and difference in blood pressure on the y-axis.*

FDA Label Image

Figure2 (Figure2)

Two line graphs illustrating the change in systolic blood pressure (mmHg) over 24 hours post-dose. The top graph shows standing systolic BP, while the bottom shows supine systolic BP. Data compares Tadalafil 20 mg with doxazosin 8 mg (solid line) and placebo with doxazosin 8 mg (dotted line). The x-axis represents time post-dose in hours, and the y-axis shows change in systolic BP.*

FDA Label Image

Figure3 (Figure3)

A line graph depicting systolic blood pressure (mmHg) changes over 12 hours following administration of tadalafil or placebo combined with doxazosin. The x-axis shows time after administration, while the y-axis represents systolic blood pressure. Four lines correspond to 20 mg tadalafil at 08:00 and 20:00 with 8 mg doxazosin, and placebo at the same times with 8 mg doxazosin.*

FDA Label Image

Figure4 (Figure4)

A line graph depicting plasma tadalafil concentration (µg/L) over time (hours) for different dosing regimens. It compares single 20-mg and 5-mg tadalafil doses, as well as once-daily 5-mg tadalafil following 5 consecutive days of administration, illustrating concentration changes and variability across a 120-hour period.*

FDA Label Image

Chemical Structure (Structure)

Chemical structure diagram of the active ingredient tadalafil, showing its molecular framework with labeled atoms and bonds.*

* 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.