Tadalafil
Product Images NDC 45865-991

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 45865-991). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Medsource Pharmaceuticals, 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

Pdp (991)

Tadalafil Tablets 20 mg packaging label from Medsource Pharmaceuticals. The label indicates the product is generic for Cialis, includes lot number and expiration date fields, and usage instructions to take tablets daily or as directed by a physician. The label also features color and shape description of the tablet (pale yellow, round), the brand Apotex Corp., and peel-off instructions.*

FDA Label Image

Figure 5 (F005)

A line graph showing change from baseline in IPSS total score over 12 weeks of treatment comparing 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. The graph indicates greater score reduction with Tadalafil than placebo, with a significant difference marked at 12 weeks (p<0.01).*

FDA Label Image

Figure 6 (F006)

A line graph showing change from baseline in IPSS Total Score over 12 weeks of treatment. It compares Tadalafil Tablets 5 mg to placebo, with Tadalafil showing greater reduction in scores over time. The x-axis represents duration of treatment in weeks, and the y-axis represents change from baseline in IPSS Total Score.*

FDA Label Image

Figure 7 (F007)

A line graph showing least squares mean change from baseline over 26 weeks of therapy. The graph compares Tadalafil/Finasteride and Placebo/Finasteride treatments, with data points at 0, 4, 12, and 26 weeks, indicating statistical significance at various points. The vertical axis measures change from baseline, and the horizontal axis represents therapy duration in weeks.*

FDA Label Image

Figure 8 (F008)

A line graph comparing change from baseline in IPSS total score over 12 weeks of treatment between Tadalafil 5 mg tablets and placebo. The graph shows greater reduction in IPSS score with Tadalafil over time, with data points at 0, 2, 4, 8, and 12 weeks. Statistical significance is indicated at week 12.*

FDA Label Image

Figure1 (Figure1)

A four-panel line graph showing changes in blood pressure measurements over time comparing Tadalafil to placebo. Panels display differences in standing systolic BP, standing diastolic BP, supine systolic BP, and supine diastolic BP over 0 to 96 hours. Each graph plots the difference in mmHg on the y-axis against time in hours on the x-axis, with error bars indicating variability.*

FDA Label Image

Figure2 (Figure2)

Two line graphs depicting changes in systolic blood pressure (mmHg) over a 24-hour period post-dose. The top graph shows standing systolic blood pressure, and the bottom graph shows supine systolic blood pressure. Each graph compares Tadalafil 20 mg with doxazosin 8 mg (solid line) against placebo with doxazosin 8 mg (dotted line) over time.*

FDA Label Image

Figure3 (Figure3)

A line graph showing the change in systolic blood pressure (mmHg) over 12 hours after administration of 20 mg tadalafil with 8 mg doxazosin or placebo with 8 mg doxazosin. The graph compares blood pressure measurements at 08:00 and 20:00 dosing times for tadalafil and placebo groups.*

FDA Label Image

Figure4 (Figure4)

A pharmacokinetic graph depicting plasma tadalafil concentration (µg/L) over time (hours) for three different dosing scenarios: single 20-mg dose, single 5-mg dose, and once-daily 5-mg dose following five consecutive days of administration. The graph includes error bars illustrating variability and shows changes in concentration from 0 to around 120 hours post-dose.*

FDA Label Image

Chemical Structure (Structure)

Chemical structure of Tadalafil, showing the molecular configuration with distinctive rings and substituent groups, as registered by medsource pharmaceuticals.*

* 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.