Macitentan Tablet, Film Coated
Product Images NDC 0378-0606

View Photos of Packaging, Regulatory Labels, and Product Appearance

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.

Product Images & Figures Index

FDA Label Image

Figure 1 (Image 01)

Figure 1 (Image 01)
FDA Label Image

Macitentan Structural Formula (Image 02)

Macitentan Structural Formula (Image 02)
FDA Label Image

Macitentan Tablets 10 mg Bottle Label (Image 03)

Macitentan Tablets 10 mg Bottle Label (Image 03)
This text provides information about a medication called Macitentan in 10 mg film-coated tablets. The recommended dosage is to take one tablet daily. Instructions suggest keeping the medication out of reach of children and storing it at 20° to 25°C. The text also includes details for pharmacists to dispense the accompanying Medication Guide and how to package the tablets. Manufacturing details indicate the product is made for Mylan Pharmaceuticals Inc. in the USA but manufactured in India.*
FDA Label Image

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

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

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

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

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

Figure 4. Kaplan-meier Estimates Of The Occurrence Of Death Due To Pah Or Hospitalization For Pah In Seraphin (Image 06)
This text appears to be a statistical summary related to a clinical trial involving Macitentan 10 mg and a placebo. It presents hazard ratio, confidence intervals, and the number of individuals at risk over a certain period from treatment start. The hazard ratio of 0.500 suggests a significant difference between the treatment group and the placebo group. The information may be used to evaluate the efficacy and safety of Macitentan 10 mg compared to a placebo in the study.*

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