Macitentan Tablet, Film Coated
Product Images NDC 62332-373

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Macitentan (NDC 62332-373). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Alembic 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

30 Tablets (Macitentan 10 mg)

Label for Macitentan Tablets 10 mg, film-coated oral tablets. The label shows dosage instructions, manufacturer as Alembic Pharmaceuticals Inc., and package quantity of 30 tablets. The label also features a barcode, regulatory information, and storage conditions.*

FDA Label Image

Figure 1 (Macitentan Fig1)

A chart showing the pharmacokinetic interaction effects on Macitentan and its active metabolite with four interacting drugs: Sildenafil, Cyclosporine-A, Ketoconazole, and Rifampin. The figure displays point estimates and 90% confidence intervals for changes in AUC and Cmax or Ctrough relative to Macitentan alone.*

FDA Label Image

Figure 2 (Macitentan Figur2)

A Kaplan-Meier survival curve graph comparing the percentage of patients event free over time between Macitentan 10 mg tablet and placebo groups. The x-axis shows months from treatment start (0 to 36), and the y-axis shows the percentage of patients event free (0% to 100%). The graph includes hazard ratio, confidence interval, and p-value data, showing higher event-free survival for Macitentan compared to placebo.*

FDA Label Image

Figure 3 (Macitentan Figur3)

A forest plot titled 'Subgroup Analysis of the SERAPHIN Study' presenting hazard ratios for various patient characteristics comparing macitentan 10 mg to placebo. It includes subgroups by age, sex, race, PAH etiology, WHO functional class, geographical region, and walk test at baseline. Each subgroup shows hazard ratios with 95% confidence intervals, event counts (Eo, Ep) and patient numbers (No, Np). The plot axis ranges from 0.1 to 10, indicating treatment effect direction.*

FDA Label Image

Figure 4 (Macitentan Figur4)

A Kaplan-Meier survival curve comparing the percentage of patients event-free over months from treatment start between Macitentan 10 mg and placebo groups. The graph shows higher event-free survival in the Macitentan group (70.63%) compared to placebo (55.4%) at 36 months. Includes hazard ratio, confidence interval, and p-value, with a table of patients at risk over time below.*

FDA Label Image

Macitentan Structure (Macitentan Structure)

Chemical structure of macitentan, depicting its molecular arrangement with bromine atoms, sulfonamide group, 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.