Tadalafil Tablet, Film Coated
Product Images NDC 69097-526

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 69097-526). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Cipla Usa Inc., 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

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Chemical structure diagram of Tadalafil, showing its molecular framework with characteristic rings and functional groups as depicted in the image.*

FDA Label Image

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A forest plot showing the mean difference in blood pressure measurements (systolic and diastolic, standing, supine, and ambulatory) comparing Tadalafil 20 mg and 10 mg to placebo, with various coadministered drugs. The plot includes mean differences with 95% confidence intervals for multiple conditions and drug combinations, illustrating changes relative to placebo in blood pressure parameters.*

FDA Label Image

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A forest plot chart illustrating pharmacokinetic interactions of various coadministered drugs with Tadalafil tablets, 20 mg. The chart shows fold change in AUC and Cmax with 90% confidence intervals for CYP3A inhibitors, inducers, antacids, and H2 antagonists compared to Tadalafil alone. Recommendations such as dose adjustment, avoid use, or no dose adjustment are listed alongside each drug interaction.*

FDA Label Image

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A forest plot chart depicting fold changes and 90% confidence intervals for various coadministered drugs compared to the drugs alone. The chart lists CYP1A2, CYP2C9, CYP3A, CYP2C9/CYP3A substrates, P-glycoprotein substrates, oral contraceptives, and NSAIDs, with corresponding fold change data indicating no dose adjustment is recommended.*

FDA Label Image

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A line graph showing mean change from baseline in meters over 16 weeks comparing placebo (N=82) and Tadalafil 40 mg (N=79). The graph indicates increases over time, with Tadalafil showing a greater mean increase than placebo. Statistical significance values are noted for weeks 8, 12, and 16.*

FDA Label Image

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A chart depicting placebo-adjusted mean change in 6-minute walk distance for subjects administered placebo versus ADCIRCA 40 mg, shown with 95% confidence intervals. The data is categorized by various subject characteristics including bosentan use, PAH etiology, baseline walk distance, gender, age, and WHO functional class.*

FDA Label Image

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A line graph showing time to clinical worsening in days on the x-axis and percentage without clinical worsening on the y-axis. The graph compares three groups labeled Tadalafil 40 mg, Tadalafil 20 mg, and Placebo, illustrating their respective percentages of patients without clinical worsening over time.*

FDA Label Image

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Tadalafil 20 mg film-coated tablets label from Cipla USA Inc. The label includes dosage instructions, storage conditions, and packaging for 60 tablets. It specifies the product is prescription-only and provides manufacturer details and barcode. The label also shows space for batch overprinting with serial number, expiry, and lot information.*

FDA Label Image

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Packaging label of Tadalafil Tablet USP 20 mg, film-coated oral tablets. The label shows a blister card format designed for two tablets, with instructions to tear, peel, and push to remove the tablets. The label also includes the manufacturer Cipla Ltd., Verna Goa, India, and Cipla USA Inc., Warren, NJ, along with the product NDC 69097-526-16 and barcode.*

* 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.