Macitentan Tablet, Film Coated
Product Images NDC 70710-1166

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Macitentan (NDC 70710-1166). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Zydus Pharmaceuticals 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 of the active ingredient Macitentan. The structure shows a complex arrangement of nitrogen, oxygen, bromine, sulfur atoms, and aromatic rings representing the molecular configuration of Macitentan.*

FDA Label Image

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A comparative forest plot chart showing point estimates and 90% confidence intervals for macitentan and its active metabolite when co-administered with four interacting drugs: sildenafil, cyclosporine-A, ketoconazole, and rifampin. The chart also includes recommendations for dose adjustment based on these interactions, indicating no dose adjustment for sildenafil and cyclosporine-A, and avoidance for ketoconazole and rifampin.*

FDA Label Image

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A Kaplan-Meier survival curve chart comparing the percentage of patients event-free over time (months) between Macitentan 10 mg and placebo groups. The solid line represents Macitentan showing higher event-free survival than the dashed placebo line over a 36-month period, including hazard ratio and confidence interval data.*

FDA Label Image

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A hazard ratio forest plot summarizing the overall treatment effect of Macitentan compared to placebo, stratified by characteristics such as age, sex, race, PAH etiology, concomitant PAH therapy, WHO functional class, geographical region, and baseline walk test distance. The plot shows hazard ratios with 95% confidence intervals for each subgroup, indicating whether the data favors Macitentan or placebo.*

FDA Label Image

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Kaplan-Meier survival curve displaying percent of patients event-free over months from treatment start comparing Macitentan 10 mg (solid line) and placebo (dashed line). The graph includes hazard ratio, confidence interval, and p-value indicating statistical significance, with patient numbers at risk listed below for both groups over time.*

FDA Label Image

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Macitentan 10 mg film-coated tablets label showing the product name, strength, and dosage form. The label includes storage instructions, dosage directions, and a child-resistant package warning. Distributed by Zydus Pharmaceuticals (USA) Inc. with manufacturing by Umedica Laboratories Pvt. Ltd. The package contains 30 tablets for oral use and is Rx only.*

* 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.