Macitentan Tablet
Product Images NDC 13668-542

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Macitentan (NDC 13668-542). 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

Image Description (281107cd 437f 4784 9be4 6f8ff01e3383 01)

Chemical structure of macitentan, showing its molecular arrangement including sulfonamide, pyrimidine, and bromophenyl groups.*

FDA Label Image

Image Description (281107cd 437f 4784 9be4 6f8ff01e3383 02)

A chart displaying the drug interaction effects of Sildenafil, Cyclosporine-A, Ketoconazole, and Rifampin on Macitentan and its active metabolite. It shows point estimates and 90% confidence intervals for changes in pharmacokinetic parameters relative to Macitentan alone, with dosage recommendations of no adjustment or avoidance accordingly.*

FDA Label Image

Image Description (281107cd 437f 4784 9be4 6f8ff01e3383 03)

A Kaplan-Meier survival curve comparing Macitentan tablets 10 mg to placebo, showing the percentage of patients event-free over 36 months from treatment start. The graph includes survival percentages for both groups, hazard ratio, confidence interval, and p-value, with a table of patients at risk at various time points.*

FDA Label Image

Image Description (281107cd 437f 4784 9be4 6f8ff01e3383 04)

A forest plot displaying hazard ratios for various characteristics comparing Macitentan tablets to placebo. It includes subgroups by age, sex, race, PAH etiology, concomitant PAH therapy at baseline, WHO functional class, geographical region, and baseline walk test results. The plot visualizes treatment effects with corresponding confidence intervals, indicating which factors favor Macitentan tablets or placebo.*

FDA Label Image

Image Description (281107cd 437f 4784 9be4 6f8ff01e3383 05)

A Kaplan-Meier survival curve depicting the percentage of patients event free over a 36-month period comparing Macitentan Tablets 10 mg to placebo. The solid line represents Macitentan with a higher event-free percentage (70.63%) versus the placebo (55.40%) shown by a dashed line. The chart includes hazard ratio, confidence interval, log-rank p-value, and number at risk data at various time points.*

FDA Label Image

Image (281107cd 437f 4784 9be4 6f8ff01e3383 06)

FDA Label Image

Logo (281107cd 437f 4784 9be4 6f8ff01e3383 08)

FDA Label Image

Image Description (281107cd 437f 4784 9be4 6f8ff01e3383 11)

Macitentan 10 mg Tablets carton label by Torrent Pharmaceuticals Limited, containing 30 oral tablets. The label displays dosage strength, directions to take one tablet daily, storage instructions between 15°C and 30°C, and dosage warnings. It features the brand and generic name, NDC 13668-542-30, and the Rx only designation.*

* 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.