Tadalafil Tablet, Film Coated
Product Images NDC 42291-865

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 42291-865). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Avkare, 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

2.5 (864 30 2.5mg)

Label for Tadalafil Tablets, USP 2.5 mg oral film-coated tablets by AvKARE. The label states the tablets are for once daily use and should not be split. The package contains 30 tablets and is for prescription use only. Storage instructions and manufacturer details are also included.*

FDA Label Image

5 (865 30 5mg)

Tadalafil Tablets, USP 5 mg film-coated tablets label from AvKARE. The label indicates the tablets should not be split and that the entire dose should be taken. It includes storage instructions, dosage directions reference, manufacturer details, and a barcode. The package contains 30 tablets for oral use, labeled for prescription use only.*

FDA Label Image

10 (866 30 10mg)

Label for Tadalafil Tablets USP 10 mg, film-coated oral tablets in a bottle of 30 tablets by AvKARE. The label includes dosage strength, storage instructions at 20° to 25°C with permitted excursions, a warning not to split tablets, and manufacturer details. The NDC number 42291-866-30 is also shown.*

FDA Label Image

20 (867 30 20mg)

Label for Tadalafil Tablets, USP 20 mg, film-coated oral tablets. The label indicates a package containing 30 tablets, manufactured for AvKARE. It includes storage instructions, a note that tablets should not be split, and a barcode.*

FDA Label Image

10 (Tadalafil Tablets Usp 1)

Chemical structure diagram of tadalafil, showing its molecular framework including a substituted indole and pyrimidinedione rings.*

FDA Label Image

10 (Tadalafil Tablets Usp 2)

A set of four line graphs illustrating the difference in blood pressure measurements (Tadalafil minus Placebo) over time in hours. The graphs show standing systolic, standing diastolic, supine systolic, and supine diastolic blood pressures with values on the y-axis ranging from -10 to 6 mmHg. Each graph displays mean differences with error bars across multiple time points up to 96 hours.*

FDA Label Image

10 (Tadalafil Tablets Usp 3)

Two line graphs depicting the change in standing and supine systolic blood pressure (mmHg) over a 24-hour period post-dose. The graphs compare the effects of Tadalafil 20 mg combined with doxazosin 8 mg against placebo with doxazosin 8 mg. The x-axis shows time in hours post-dose, and the y-axis shows blood pressure changes.*

FDA Label Image

10 (Tadalafil Tablets Usp 4)

A line graph depicting the effect of 20 mg tadalafil versus placebo on systolic blood pressure (mmHg) over 12 hours after administration. The graph compares systolic BP changes at two dosing times (08:00 and 20:00), with and without 8 mg daily doxazosin, showing four data series with varying BP values over time.*

FDA Label Image

10 (Tadalafil Tablets Usp 5)

A line graph showing plasma tadalafil concentration (mcg/L) over time (hours) comparing three dose regimens: single 20-mg tadalafil dose, single 5-mg tadalafil dose, and once-daily 5-mg tadalafil following 5 consecutive days of administration. Error bars indicate variability at each time point.*

FDA Label Image

10 (Tadalafil Tablets Usp 6)

A line graph displaying the change from baseline in IPSS Total Score over a 12-week treatment period comparing Tadalafil 5 mg and placebo. The X-axis shows duration in weeks (0, 4, 8, 12), and the Y-axis shows the change from baseline, with values decreasing below zero. Two lines represent Tadalafil 5 mg and placebo groups, indicating greater score reduction for the Tadalafil group with statistical significance noted at p<0.01.*

FDA Label Image

10 (Tadalafil Tablets Usp 7)

A line graph comparing change from baseline in IPSS total score over a 12-week treatment period for Tadalafil 5 mg versus placebo. The x-axis represents treatment duration in weeks (0, 1, 4, 8, 12), and the y-axis shows change in score. Data points show a greater decrease in score for Tadalafil 5 mg compared to placebo, with statistical significance indicated at weeks 4 and 12 (p<0.01).*

FDA Label Image

10 (Tadalafil Tablets Usp 8)

A line graph depicting the least-squares mean change from baseline over 26 weeks of therapy comparing Tadalafil/Finasteride and Placebo/Finasteride. The x-axis shows weeks of therapy (0, 4, 12, 26) and the y-axis shows the change from baseline. Data points indicate significant differences at specific times with annotations for p-values.*

FDA Label Image

10 (Tadalafil Tablets Usp 9)

A line graph showing the change from baseline in IPSS total score over a 12-week treatment period comparing Tadalafil 5 mg and placebo. The x-axis represents duration of treatment in weeks (0, 2, 4, 8, 12) and the y-axis shows change from baseline. Tadalafil 5 mg shows a greater decrease in score over time compared to placebo.*

* 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.