Macitentan Tablet, Film Coated
Product Images NDC 59651-147

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Macitentan (NDC 59651-147). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma 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

Figure-1 (Macitentan Fig1)

A chart displaying the effects of various interacting drugs—Sildenafil, Cyclosporine-A, Ketoconazole, and Rifampin—on Macitentan and its active metabolite. It presents point estimates and 90% confidence intervals for pharmacokinetic parameters such as AUC (area under the curve) and Cmax or Ctrough, showing changes relative to Macitentan alone.*

FDA Label Image

Figure-2 (Macitentan Fig2)

A Kaplan-Meier survival curve chart comparing the percentage of patients event-free over time between Macitentan 10 mg and placebo groups. The x-axis shows months from treatment start (0 to 36 months), and the y-axis shows the percentage of patients event-free (0 to 100%). The Macitentan group curve remains higher, indicating a higher event-free survival rate (63.18%) compared to placebo (47.04%). Additional data include hazard ratio, confidence interval, logrank p-value, and numbers at risk for each group over time.*

FDA Label Image

Figure-3 (Macitentan Fig3)

A forest plot displaying hazard ratios with 95% confidence intervals for various patient characteristics related to Macitentan treatment efficacy. The horizontal axis ranges from 0.1 to 10, indicating favorability towards Macitentan or placebo. Patient subgroups include age, sex, race, PAH etiology, concomitant PAH therapy, WHO functional class, geographical region, and baseline walk test distance.*

FDA Label Image

Figure-4 (Macitentan Fig4)

A Kaplan-Meier survival curve chart comparing the percentage of patients event free over months from treatment start between Macitentan 10 mg and placebo groups, showing higher event-free survival for Macitentan. The chart includes patient numbers at risk over time and statistical data such as hazard ratio and confidence interval.*

FDA Label Image

Package Label-principal Display Panel (10 mg (30 Tablets Bottle))

Label for Macitentan Tablets 10 mg film-coated oral tablets by Aurobindo Pharma Limited. The label states each tablet contains 10 mg macitentan, packaged 30 tablets per container. Includes storage instructions, distributor info (Aurobindo Pharma USA, Inc.), and a barcode. Directions reference dispensing the Medication Guide separately for patients.*

FDA Label Image

Chemical Structure (Macitentan Str)

Chemical structure of macitentan, showing its molecular arrangement including bromine-substituted phenyl and pyrimidine rings.*

* 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.