Macitentan Tablet, Film Coated
Product Images NDC 60505-4644

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Macitentan (NDC 60505-4644). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Apotex Corp., 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

Chemicalstructure.jpg (Chemicalstructure)

FDA Label Image

Figure1.jpg (Figure1)

FDA Label Image

Figure2.jpg (Figure2)

This text provides information on the Kaplan-Meier analysis of patients being event-free over time. It includes data related to the comparison of Macitentan 10 mg versus Placebo, such as the percentage of patients event-free, hazard ratio, confidence interval, logrank p-value, and the duration in months from treatment start.*

FDA Label Image

Figure3.jpg (Figure3)

FDA Label Image

Figure4.jpg (Figure4)

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Macitentan-blister-carton-15s.jpg (Macitentan Blister Carton 15s)

This text contains information about Macitentan Tablets 10 mg, with instructions for pharmacists to dispense the Medication Guide to each patient. It also mentions details for Hospital Use Only and provides manufacturer details for Apotex Corp. The tablets are manufactured in Toronto, Canada, and Weston, Florida. The text ends with a note about a non-varnish area for lot and expiry information.*

FDA Label Image

Macitentan-bottle-10mg-30s.jpg (Macitentan Bottle 10mg 30s)

FDA Label Image

Macitentan-bottle-carton-30.jpg (Macitentan Bottle Carton 30)

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