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)

This is information from a pharmaceutical package for Macitentan Tablets. The tablets contain 10mg of the active ingredient and the usual dosage is one tablet daily. It is recommended to store the tablets at a temperature between 20°C to 25°C (68°F to 77°F). The package is child-resistant. The medication should be kept out of reach of children. The package includes a medication guide for each patient. The tablets are manufactured by Alembic Pharmaceuticals and the packaging has a GTIN code: 00362332373307.*

FDA Label Image

Figure 1 (Macitentan Fig1)

FDA Label Image

Figure 2 (Macitentan Figur2)

This text appears to be showing the comparison of Macitentan 10mg vs. Placebo in a study, indicating the hazard ratio, confidence interval, and log-rank p-value. It also displays the number of participants at risk over different months from treatment start for both Macitentan and Placebo groups.*

FDA Label Image

Figure 3 (Macitentan Figur3)

This text provides a detailed subgroup analysis of the SERAPHIN study, evaluating the hazard ratios for different characteristics such as age, sex, race, PAH etiology, WHO FC at baseline, and geogaphical region among others. The analysis includes comparisons between macitentan and placebo groups, with specific numbers of events and patients in each category. The study also mentions specific notes related to patients under 18 years and those with WHO FC I at baseline.*

FDA Label Image

Figure 4 (Macitentan Figur4)

This is a statistical data presenting the event-free percentage of patients over time using Kaplan-Meier analysis. The study compared the efficacy of Macitentan 10mg with a placebo in a group of patients. The hazard ratio was found to be 0.5 with a confidence interval of 97.5% (0.335, 0.747). The logrank p-value was reported to be less than 0.001, indicating a significant difference between the two groups. The table shows the number of patients at risk for both treatments at different time points from the beginning of treatment, suggesting Macitentan 10 mg had a higher event-free rate compared to the placebo.*

FDA Label Image

Macitentan Structure (Macitentan Structure)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.