Macitentan Tablet, Film Coated
Product Images NDC 0781-8135

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Macitentan (NDC 0781-8135). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sandoz 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

Macitentan-10mg-30s-container-label (Macitentan 10mg 30s Container Label)

This is a medication label for Macitentan tablets, with each tablet containing 10 mg of the active ingredient. The usual recommended dosage is one 10 mg tablet per day. It is important to keep the tablets out of reach of children and store them at a temperature between 20°C to 25°C. The medication is manufactured by MSN Laboratories Private Limited in Telangana, India, for Sandoz Inc. It advises pharmacists to dispense the accompanying medication guide to each patient. Sandoz is listed as the manufacturer and the label includes a product code.*

FDA Label Image

Macitentan-figure-01 (Macitentan Figure 01)

FDA Label Image

Figure-02 (Macitentan Figure 02)

This text represents data from a study comparing a drug called Macitentan 10mg with a placebo. The hazard ratio was found to be 0.547 with a 97.5% confidence interval of (0.392, 0.762), indicating a significant difference between the two groups. The Logrank p-value was reported to be less than .0001. The study shows the percentage of patients in each group at different time points, along with the number of patients at risk in each group. The data spans over a period of 36 months from the start of treatment.*

FDA Label Image

Macitentan-figure-03 (Macitentan Figure 03)

This data table provides Hazard Ratios and treatment effects for various factors such as age, gender, race, etiology, therapy, WHO functional class, geographical region, and baseline characteristics for patients using macitentan compared to placebo. The information is presented in terms of Hazard Ratios with confidence intervals for different endpoints and subgroups. The table also includes the number of patients in each category for comparison between macitentan and placebo groups.*

FDA Label Image

Fig-04 (Macitentan Figure 04)

FDA Label Image

Structure (Macitentan Structure)

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