Tadalafil Tablet, Film Coated
Product Images NDC 82804-040

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 82804-040). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Proficient Rx Lp, 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

82804-040-30 (Tadalafil 5 mg 30s)

Label for Tadalafil 5 mg film-coated tablets, #30 count, manufactured by Umedica Laboratories Pvt. Ltd. It is labeled by Proficient Rx LP. The label indicates the tablets are yellow, almond-shaped, debossed with "T5" and advises that tablets should not be split and the entire dose taken. Storage instructions specify 25°C (77°F).*

FDA Label Image

Tadalafil-figure-1 (Tadalafil Figure 1)

This image contains four line graphs showing the differences in blood pressure measurements between tadalafil and placebo over time. The graphs display Standing Systolic BP, Standing Diastolic BP, Supine Systolic BP, and Supine Diastolic BP in mmHg on the y-axis, plotted against time in hours on the x-axis, each with error bars indicating variability.*

FDA Label Image

Tadalafil-figure-2 (Tadalafil Figure 2)

Two line graphs showing changes in systolic blood pressure (mmHg) over 24 hours post-dose for Tadalafil 20 mg with doxazosin 8 mg versus placebo with doxazosin 8 mg. The top graph depicts standing systolic BP, and the bottom graph depicts supine systolic BP, with time post-dose on the x-axis and BP changes on the y-axis.*

FDA Label Image

Tadalafil-figure-3 (Tadalafil Figure 3)

A line graph depicting the change in systolic blood pressure (mmHg) over 12 hours following administration of tadalafil or placebo alongside doxazosin. Four lines represent different dosing times and combinations: 20 mg tadalafil at 08:00 with 8 mg doxazosin; placebo at 08:00 with 8 mg doxazosin; 20 mg tadalafil at 20:00 with 8 mg doxazosin; and placebo at 20:00 with 8 mg doxazosin. The y-axis shows systolic BP changes and the x-axis the time after dosing.*

FDA Label Image

Tadalafil-figure-4 (Tadalafil Figure 4)

A pharmacokinetic graph showing plasma tadalafil concentration (µg/L) over time (hours). The chart compares three dosing regimens: a single 20-mg dose, a single 5-mg dose, and once-daily 5-mg dosing after 5 consecutive days, with concentration values decreasing over time for each regimen and error bars indicating variability.*

FDA Label Image

Tadalafil-figure-5 (Tadalafil Figure 5)

A line graph showing change from baseline in IPSS Total Score over a 12-week treatment duration. It compares Tadalafil Tablets 5 mg (solid line with filled circles) and Placebo (dashed line with open triangles). The graph indicates greater score reduction for Tadalafil at weeks 4, 8, and 12, with statistical significance marked by P < 0.01.*

FDA Label Image

Tadalafil-figure-6 (Tadalafil Figure 6)

Line graph depicting change from baseline in IPSS Total Score over a 12-week treatment duration. It compares Tadalafil Tablets 5 mg and Placebo groups, showing a greater score reduction with Tadalafil over time. Time (weeks) is on the x-axis and change in score on the y-axis. A statistical significance annotation (P < 0.01) is included.*

FDA Label Image

Tadalafil-figure-7 (Tadalafil Figure 7)

A line graph comparing the least-squares mean change from baseline over 26 weeks of therapy for two groups: Tadalafil/Finasteride and Placebo/Finasteride. The x-axis represents weeks of therapy (0, 4, 12, 26), and the y-axis shows least-squares mean change from baseline. Tadalafil/Finasteride shows greater reductions over time compared to Placebo/Finasteride, with statistical significance noted at various points.*

FDA Label Image

Tadalafil-figure-8 (Tadalafil Figure 8)

A line graph comparing changes from baseline in IPSS Total Score over 12 weeks between Tadalafil tablets 5 mg and placebo. The x-axis represents duration of treatment in weeks, and the y-axis shows change from baseline in IPSS Total Score. Data points indicate greater reduction in score with Tadalafil over time compared to placebo, with significance noted at week 12.*

FDA Label Image

Tadalafil-structure (Tadalafil Structure)

Chemical structure diagram of tadalafil showing its molecular framework including nitrogen and oxygen atoms in the 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.