Macitentan Tablet, Film Coated
Product Images NDC 0480-0915

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Macitentan (NDC 0480-0915). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Teva 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

1 (Image 1)

Chemical structure of macitentan, showing its molecular configuration including brominated phenyl groups and sulfonamide moiety as part of its chemical composition.*

FDA Label Image

New (Image 2)

A pharmacokinetic interaction chart showing the effects of various interacting drugs on macitentan and its active metabolite. The graph plots point estimates and 90% confidence intervals for parameters such as AUCtau, Cmax, and Ctrough, indicating changes relative to macitentan alone for interacting drugs including Sildenafil, Cyclosporine-A, Ketoconazole, and Rifampin.*

FDA Label Image

1 (Image 3)

A Kaplan-Meier survival curve chart showing the percentage of patients event free over time in months from treatment start, comparing Macitentan 10 mg tablets to placebo. The chart includes risk numbers at different time points and statistical data such as hazard ratio, confidence interval, and p-value.*

FDA Label Image

1 (Image 4)

A forest plot chart showing hazard ratios with 95% confidence intervals for various patient characteristics comparing macitentan versus placebo. It includes categories like age, sex, race, PAH etiology, baseline therapies, WHO functional class, geographical region, and walk test results, indicating statistical comparisons of treatment effects favoring macitentan for multiple subgroups.*

FDA Label Image

1 (Image 5)

Kaplan-Meier curve showing percentage of patients event-free over time comparing Macitentan 10 mg tablets versus placebo. The x-axis represents months from treatment start up to 36 months, and the y-axis indicates the percentage of patients event-free. Numbers at risk for each group are listed below the timeline.*

FDA Label Image

New (Image 6)

Macitentan Tablets 10 mg film-coated tablets label showing package size of 30 tablets. The label includes storage instructions, barcode, NDC 0480-0915-56, manufacturer details (Teva Pharmaceutical Ind. Ltd., Israel), and a note for pharmacists to dispense the accompanying medication guide. The labeler is Teva Pharmaceuticals, Inc.*

* 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.