Tadalafil Tablet
Product Images NDC 13668-581

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 13668-581). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Torrent Pharmaceuticals Limited, 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

Structural Formula (A7bacee2 C3dd 45c4 8c75 0f51661a51f3 01)

Chemical structure diagram of the active ingredient Tadalafil, showing its molecular framework including rings and functional groups as depicted in the label set for the TADALAFIL 20 mg oral tablet by Torrent Pharmaceuticals Limited.*

FDA Label Image

Figure 1 (A7bacee2 C3dd 45c4 8c75 0f51661a51f3 02)

A line graph showing mean change from baseline in meters over 0 to 16 weeks comparing placebo (N=82) and tadalafil 40 mg (N=79). The tadalafil group shows an increasing trend up to about 41 meters at 16 weeks, while placebo remains near 10 meters. Statistically significant differences between tadalafil and placebo at weeks 8, 12, and 16 are indicated by p-values of 0.0152, 0.0084, and 0.0004 respectively.*

FDA Label Image

Figure 2 (A7bacee2 C3dd 45c4 8c75 0f51661a51f3 03)

A forest plot chart showing placebo-adjusted mean change in 6-minute walk distance (meters) for tadalafil 40 mg compared to placebo. The chart compares subgroups including all ITT subjects, bosentan use, PAH etiology, baseline walk distance, gender, age, and WHO functional class. Each subgroup is displayed with mean change values and 95% confidence intervals.*

FDA Label Image

Figure 3 (A7bacee2 C3dd 45c4 8c75 0f51661a51f3 04)

A Kaplan-Meier survival curve chart showing the percentage without clinical worsening over time in days. The chart compares three groups: tadalafil 40 mg, tadalafil 20 mg, and placebo, each represented by different line styles. The vertical axis shows percentage without clinical worsening from 0 to 100, and the horizontal axis shows time to clinical worsening up to 150 days.*

FDA Label Image

Logo (A7bacee2 C3dd 45c4 8c75 0f51661a51f3 05)

FDA Label Image

Logo (A7bacee2 C3dd 45c4 8c75 0f51661a51f3 06)

FDA Label Image

Container Label (A7bacee2 C3dd 45c4 8c75 0f51661a51f3 07)

Label for Tadalafil Tablets USP 20 mg by Torrent Pharmaceuticals Limited. The oral tablet packaging contains 30 tablets with NDC 13668-581-30. The label includes storage instructions, dosage information recommending 20 mg tablets taken two at a time up to 40 mg daily, and notes it is Rx only.*

FDA Label Image

Figure 1

A forest plot showing mean differences in blood pressure measures (systolic and diastolic, standing, supine, and ambulatory) comparing Tadalafil 20 mg to placebo, alone and coadministered with various drugs including alcohol, Adefovir, Amlodipine, Angiotensin II receptor blockers, Bendroflumethiazide, and Enalapril. Mean differences with 95% confidence intervals are plotted to indicate the effect size relative to placebo across multiple conditions.*

FDA Label Image

Figure 2

A figure showing fold change and 90% confidence intervals of pharmacokinetic parameters (AUC and Cmax) for various drugs coadministered with Tadalafil. The graph presents the change relative to Tadalafil alone for CYP3A inhibitors, CYP3A inducers, antacids, and H2 antagonists, along with dosing recommendations including dose adjustment, avoid use, or no dose adjustment.*

FDA Label Image

Figure 3

A chart illustrating fold change and 90% confidence intervals for various coadministered drugs' pharmacokinetic parameters (AUC, Cmax, bleeding time) relative to coadministered drug alone, with corresponding dosing recommendations, all indicating no dose adjustment needed for Tadalafil coadministration.*

* 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.