Tadalafil Tablet, Film Coated
Product Images NDC 68180-914

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 68180-914). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Lupin Pharmaceuticals, 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 the arrangement of its molecular components as represented by lines and atomic symbols.*

FDA Label Image

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Forest plot chart illustrating mean differences in blood pressure measurements (systolic and diastolic) comparing tadalafil to placebo with various coadministered drugs. The x-axis represents the scale of mean difference relative to placebo, including confidence intervals for each comparison, showing effects of different drug combinations on standing, supine, and ambulatory blood pressure values.*

FDA Label Image

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A chart showing fold change and 90% confidence intervals for the effect of various coadministered drugs on Tadalafil pharmacokinetics. The x-axis displays change relative to Tadalafil alone, ranging from 0.0 to 5.0. The chart compares drugs including CYP3A inhibitors (Ritonavir, Ketoconazole), CYP3A inducers (Rifampin, Bosentan), antacids, and H2 antagonists, with corresponding recommendations such as dose adjustment, avoid use, or no dose adjustment.*

FDA Label Image

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A forest plot chart depicting fold change and 90% confidence intervals for various coadministered drugs with Tadalafil. The chart shows differences in AUC and Cmax or bleeding time relative to the coadministered drug alone, with recommendations indicating no dose adjustment is necessary for all listed drugs including theophylline, warfarin (R- and S-forms), midazolam, lovastatin, bosentan, digoxin, oral contraceptives (ethinyl estradiol and levonorgestrel), and aspirin.*

FDA Label Image

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A line graph comparing the mean change from baseline in meters over 16 weeks between placebo (N=82) and Tadalafil 40 mg (N=79). The vertical axis shows mean change in meters, and the horizontal axis shows weeks (0, 4, 8, 12, 16). The Tadalafil 40 mg group shows a steady increase from 0 to about 40 meters, while the placebo group shows a smaller increase leveling off around 10 meters. Statistical significance is indicated at weeks 8, 12, and 16 with p-values of 0.0152, 0.0084, and 0.0004 respectively.*

FDA Label Image

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A forest plot chart displaying the placebo-adjusted mean change in 6-minute walk distance (meters) with Tadalafil 40 mg compared to placebo across various subject subgroups. The plot includes categories such as bosentan use, PAH etiology, baseline walk distance, gender, age, and WHO functional class, with confidence intervals indicated for each subgroup. Sample sizes for placebo and tadalafil groups are listed alongside the subgroups.*

FDA Label Image

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A line graph showing the percentage of subjects without clinical worsening over time in days. The graph compares Tadalafil 40 mg, Tadalafil 20 mg, and placebo groups, illustrating time to clinical worsening with separate lines for each group across a 150-day period.*

FDA Label Image

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Label for Tadalafil Tablets USP 20 mg oral film-coated tablets by Lupin Pharmaceuticals, Inc. The label indicates a package containing 30 tablets. It displays the NDC number 68180-914-06, storage conditions, dosage instructions, and manufacturer details with Lupin Limited in India listed as the manufacturer. The label includes an image of a small round orange tablet marked "L 124".*

* 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.