Macitentan Tablet, Film Coated
Product Images NDC 42385-907

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)

A comparative chart showing the pharmacokinetic interaction of Macitentan and its active metabolite with four interacting drugs: Sildenafil, Cyclosporine-A, Ketoconazole, and Rifampin. The chart illustrates point estimates and 90% confidence intervals for parameters AUCtau, Cmax, and Ctrough relative to Macitentan alone, with separate plots for Macitentan and its active metabolite.*

FDA Label Image

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

A Kaplan-Meier survival curve comparing the percentage of patients surviving over 36 months from treatment start between Macitentan 10 mg and placebo groups. The chart shows higher survival for the Macitentan group (63.18%) than placebo (47.04%). It includes hazard ratio 0.547, 97.5% CI (0.392, 0.762), and logrank p-value <.0001, with numbers at risk listed below the time axis.*

FDA Label Image

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

A forest plot chart depicting hazard ratios for macitentan versus placebo across various patient subgroups based on characteristics such as age, sex, race, PAH etiology, concomitant PAH therapy, WHO functional class, geographical region, and walking test distance at baseline. The plot visually presents treatment effect estimates with confidence intervals, indicating where the treatment favors macitentan or placebo.*

FDA Label Image

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

A Kaplan-Meier survival curve comparing Macitentan 10 mg to placebo over 36 months, showing the percentage of patients event-free from treatment start. The solid line represents Macitentan 10 mg, maintaining around 70.63% event-free, while the dashed line represents placebo with 55.40% event-free. The chart includes a table of the number of patients at risk at various time points and statistical data including hazard ratio and p-value.*

FDA Label Image

Macitentan-figure6.jpg (Macitentan Figure6)

Label for Macitentan Tablets 10 mg film coated oral tablets. The label shows the strength as 10 mg, includes storage instructions (20° to 25°C, with permitted excursions), dispensing guidance, and manufacturer information: Laurus Labs Limited in India, manufactured for Laurus Generics Inc., Berkeley Heights, NJ. The label also states the package contains 30 tablets.*

FDA Label Image

Macitentan-figure7.jpg (Macitentan Figure7)

Sheet of multiple Macitentan 10 mg film-coated tablet labels for oral use from Laurus Labs Limited. Each label shows the product name, strength, manufacturer, bar code, and space for lot and expiration information. Labels are arranged in three columns and five rows on a perforated sheet.*

FDA Label Image

Macitentan-figure8.jpg (Macitentan Figure8)

Packaging label for Macitentan Tablets 10 mg oral film-coated tablets, containing 15 tablets in a unit-dose format. The label indicates hospital use only with instructions for pharmacists to dispense the accompanying Medication Guide. Manufactured by Laurus Labs Limited, the packaging includes NDC 42385-907-15 and the Laurus Labs logo.*

FDA Label Image

Macitentan-figure9.jpg (Macitentan Figure9)

Text panel listing symptoms or side effects such as nausea, vomiting, upper right stomach pain, tiredness, loss of appetite, yellowing of skin or eyes, dark urine, fever, and itching, typically part of patient information for Macitentan tablets.*

FDA Label Image

Macitentan-structure1.jpg (Macitentan Structure1)

Chemical structure diagram of the active ingredient Macitentan showing its molecular arrangement including bromine substituents and sulfonamide group.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.