Tadalafil Tablet, Film Coated
Product Images NDC 33342-278

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 33342-278). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Macleods 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

Tadalafil-20mg-30-container (Tadalafil 20mg 30 Bottle)

Label for Tadalafil Tablets, USP 20 mg film-coated tablets by Macleods Pharmaceuticals Limited. The label shows the product name, strength (20 mg), oral dosage form, and package quantity of 30 tablets. Manufacturer and labeler details include Macleods Pharma USA, Inc., Plainsboro, NJ, and manufacturing in Daman, India. Dosage instructions and storage information are also visible.*

FDA Label Image

Tadalafil-20mg-60-container (Tadalafil 20mg 60 Bottle)

Label for Tadalafil Tablets USP 20 mg film coated tablets by Macleods Pharma USA. It includes dosage strength, quantity of 60 tablets, storage instructions, manufacturer details, and warning to keep out of reach of children. The barcode and NDC 33342-278-09 are visible along with directions for use and storage temperatures.*

FDA Label Image

Tadalafil Fig1

A forest plot chart showing the mean differences in blood pressure measurements (systolic and diastolic, in standing, supine, and ambulatory positions) comparing tadalafil 20 mg with placebo. The chart includes data on coadministered drugs like alcohol, alfuzosin, amlodipine, angiotensin II receptor blockers, doxazosin, tamsulosin, bendroflumethiazide, enalapril, and metoprolol, with 95% confidence intervals represented visually and numerically.*

FDA Label Image

Tadalafil Fig2

A chart showing fold change and 90% confidence intervals for various coadministered drugs relative to Tadalafil alone, including CYP3A inhibitors, CYP3A inducers, antacids, and H2 antagonists. The chart includes recommendations such as dose adjustment, avoid use, or no dose adjustment based on the drug interaction effects on AUC and Cmax values.*

FDA Label Image

Tadalafil Fig3

A forest plot chart showing fold changes and 90% confidence intervals for various drugs coadministered with another drug. The x-axis represents change relative to coadministered drug alone, ranging from 0.00 to 2.00. Drugs listed include CYP1A2, CYP2C9, CYP3A substrates, P-glycoprotein substrate, oral contraceptives, and NSAIDs, with corresponding recommendations—all indicating no dose adjustment.*

FDA Label Image

Tadalafil Fig5

Line graph depicting mean change from baseline in meters over 16 weeks comparing placebo (N=82) and Tadalafil 40 mg (N=79). The y-axis represents mean change in meters and the x-axis represents weeks. Tadalafil shows a greater increase over time with statistical significance indicated at weeks 8, 12, and 16.*

FDA Label Image

Figure2 (Tadalafil Figure2)

A forest plot showing placebo-adjusted mean change in 6-minute walk distance (meters) for Tadalafil 40 mg versus placebo across various subgroups of study subjects. The horizontal axis represents change in meters, with 95% confidence intervals depicted for each subgroup, including gender, age, baseline functional class, and specific disease etiologies.*

FDA Label Image

Figure3 (Tadalafil Figure3)

A Kaplan-Meier survival curve chart depicting the percentage without clinical worsening over time in days. The chart compares Tadalafil 40 mg (solid thick line), Tadalafil 20 mg (dashed line), and placebo (thin solid line), showing the trend in clinical worsening among these groups over approximately 140 days.*

FDA Label Image

Str (Tadalafil Str)

Chemical structure of Tadalafil illustrating its molecular framework with multiple ring systems and functional groups in a two-dimensional format.*

* 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.