Macitentan Tablet, Film Coated
Product Images NDC 0378-0606

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Macitentan (NDC 0378-0606). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Mylan 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

Figure 1 (Image 01)

A chart comparing the pharmacokinetic effects of four interacting drugs—Sildenafil, Cyclosporine-A, Ketoconazole, and Rifampin—on Macitentan and its active metabolite. The chart shows point estimates and 90% confidence intervals for AUCtau and Cmax (or Ctrough) changes relative to Macitentan alone for each drug interaction.*

FDA Label Image

Macitentan Structural Formula (Image 02)

Chemical structure of Macitentan showing its molecular composition with distinct functional groups including sulfonamide, bromine-substituted aromatic rings, and a piperazine moiety.*

FDA Label Image

Macitentan Tablets 10 mg Bottle Label (Image 03)

Macitentan 10 mg film-coated tablets label showing the product name, strength, dosage form, and quantity of 30 tablets. Manufactured for Mylan Pharmaceuticals Inc., the label includes storage instructions, a pill imprint image (MC 10), and dispensing guidance. The label emphasizes prescription-only status and features Mylan branding and barcodes.*

FDA Label Image

Figure 2. Kaplan-meier Estimates Of The Occurrence Of The Primary Endpoint Event In The Seraphin Study (Image 04)

Kaplan-Meier survival curve comparing percentage of patients event-free over months from treatment start for Macitentan 10 mg versus placebo. The chart includes a hazard ratio, confidence interval, and logrank p-value, with patient numbers at risk tabled below across time points up to 36 months.*

FDA Label Image

Figure 3. Subgroup Analysis Of The Seraphin Study (Image 05)

A forest plot chart depicting hazard ratios for various characteristics comparing Macitentan to placebo. It includes subgroups by age, sex, race, PAH etiology, concomitant PAH therapy, WHO functional class at baseline, geographical region, and baseline walk test. The horizontal axis shows hazard ratios on a logarithmic scale, with markers and confidence intervals illustrating treatment effects favoring Macitentan or placebo.*

FDA Label Image

Figure 4. Kaplan-meier Estimates Of The Occurrence Of Death Due To Pah Or Hospitalization For Pah In Seraphin (Image 06)

A Kaplan-Meier survival curve chart showing the percentage of patients event-free over months from treatment start. Two groups are compared: Macitentan 10 mg (solid line) and placebo (dashed line). The chart includes hazard ratio, confidence interval, and p-value, with the Macitentan group showing higher event-free survival at 36 months (70.63%) compared to placebo (55.40%). A table below shows patient numbers at risk over time for each group.*

* 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.