Tadalafil Tablet, Film Coated
Product Images NDC 82804-042

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 82804-042). 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

82804-042-30 (Tadalafil 20 mg 30s)

Label for Tadalafil 20 mg tablets by Proficient Rx LP, containing 30 film-coated tablets. The label states each tablet contains 20 mg of Tadalafil USP and describes tablets as yellow, almond-shaped, debossed with "T20." Manufacturer is Umedica Laboratories Pvt. Ltd., India. Instructions note tablets should not be split and medication should be kept out of reach of children.*

FDA Label Image

Tadalafil-figure-1 (Tadalafil Figure 1)

Four line graphs illustrating the difference in blood pressure (mmHg) between Tadalafil and placebo over time (0 to 96 hours). The graphs show standing systolic, standing diastolic, supine systolic, and supine diastolic blood pressure differences, with time on the x-axis and pressure difference on the y-axis, including error bars for variability.*

FDA Label Image

Tadalafil-figure-2 (Tadalafil Figure 2)

A dual line graph showing standing and supine systolic blood pressure (mmHg) changes over 24 hours post-dose. It compares Tadalafil 20 mg with doxazosin 8 mg versus placebo with doxazosin 8 mg, illustrating blood pressure trends in both positions over time.*

FDA Label Image

Tadalafil-figure-3 (Tadalafil Figure 3)

A line graph depicting changes in systolic blood pressure (mmHg) over 12 hours after administration of tadalafil or placebo along with doxazosin. Four data series compare 20 mg tadalafil (08:00) plus doxazosin, placebo (08:00) plus doxazosin, 20 mg tadalafil (20:00) plus doxazosin, and placebo (20:00) plus doxazosin, illustrating blood pressure variations over time post-dose.*

FDA Label Image

Tadalafil-figure-4 (Tadalafil Figure 4)

A line chart showing plasma tadalafil concentration (µg/L) over time (hours) for three dosing regimens: a single 20 mg dose, a single 5 mg dose, and once-daily 5 mg dose after 5 consecutive days. Data points include error bars and demonstrate drug concentration decreasing over time with distinct profiles for each regimen.*

FDA Label Image

Tadalafil-figure-5 (Tadalafil Figure 5)

A line graph comparing change from baseline in IPSS total score over 12 weeks of treatment between Tadalafil 5 mg tablets and placebo. The x-axis represents treatment duration in weeks (0, 4, 8, 12) and the y-axis shows change in score ranging from 0 to -6. Tadalafil shows a greater reduction over time than placebo, with statistically significant differences indicated by P < 0.01.*

FDA Label Image

Tadalafil-figure-6 (Tadalafil Figure 6)

A line graph comparing change from baseline in IPSS total scores over a 12-week treatment duration between Tadalafil Tablets 5 mg and placebo groups. The graph shows data points at 0, 1, 4, 8, and 12 weeks, with Tadalafil demonstrating greater score reduction than placebo. Statistical significance indicated at week 4 (P < 0.01).*

FDA Label Image

Tadalafil-figure-7 (Tadalafil Figure 7)

A line graph illustrating least-squares mean change from baseline over 26 weeks of therapy for two treatments: Tadalafil/Finasteride and Placebo/Finasteride. The x-axis represents weeks of therapy (0, 4, 12, 26), and the y-axis shows LS mean change from baseline, with values decreasing from 0.0 to -7.0. Tadalafil/Finasteride shows a more pronounced decrease compared to Placebo/Finasteride throughout the weeks. Statistical significance markers (a and b) indicate differences at various time points.*

FDA Label Image

Tadalafil-figure-8 (Tadalafil Figure 8)

A line graph comparing change from baseline in IPSS total score over 12 weeks of treatment between tadalafil 5 mg tablets and placebo groups. The y-axis shows the change in score, and the x-axis shows the duration of treatment in weeks. Data points indicate significantly greater score reduction with tadalafil by week 12 (p<0.01).*

FDA Label Image

Tadalafil-structure (Tadalafil Structure)

Chemical structure of Tadalafil illustrating its molecular arrangement with characteristic rings and functional groups as depicted in the diagram.*

* 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.