Macitentan Tablet, Film Coated
Product Images NDC 42385-907

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Macitentan (NDC 42385-907). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Laurus Labs Limited, 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-figure1.jpg (Macitentan Figure1)

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Figure 2 Kaplan-meier Estimates Of The Occurrence Of The Primary Endpoint Event In The Seraphin Study (Macitentan Figure2)

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Figure 3 Subgroup Analysis Of The Seraphin Study (Macitentan Figure3)

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Figure 4 Kaplan-meier Estimates Of The Occurrence Of Death Due To Pah Or Hospitalization For Pah In Seraphin (Macitentan Figure4)

FDA Label Image

Macitentan-figure6.jpg (Macitentan Figure6)

Macitentan-figure6.jpg (Macitentan Figure6)
This description provides details about a medication in the form of film-coated tablets containing 10 mg of macitentan. The tablets should be taken once daily. The manufacturing information includes the company name, dosage instructions, and storage conditions. Pharmacies are instructed to dispense the medication with an accompanying Medication Guide for each patient. It advises to keep the medication out of reach of children. The text also mentions the expiration date and quantity of tablets.*
FDA Label Image

Macitentan-figure7.jpg (Macitentan Figure7)

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Macitentan-figure8.jpg (Macitentan Figure8)

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Macitentan-figure9.jpg (Macitentan Figure9)

Macitentan-figure9.jpg (Macitentan Figure9)
This text mentions symptoms related to possible liver issues, such as nausea, vomiting, pain in the upper right stomach, tiredness, loss of appetite, yellowing of the skin or eyes, dark urine, fever, and itching. These symptoms could indicate a need for medical evaluation.*
FDA Label Image

Macitentan-structure1.jpg (Macitentan Structure1)

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