Macitentan Tablet, Film Coated
Product Images NDC 47335-070

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Macitentan (NDC 47335-070). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sun Pharmaceutical Industries, 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

Bottle Label (Bottle Label)

Label for Macitentan Tablets 10 mg oral film-coated tablets by Sun Pharmaceutical Industries, Inc. The label indicates a package of 30 tablets and includes instructions for pharmacists to dispense the Medication Guide with each prescription. Storage conditions and manufacturer information are also shown, along with barcodes and the product NDC 47335-070.*

FDA Label Image

Carton Label (Carton Label)

Packaging label for Macitentan Tablets 10 mg by Sun Pharmaceutical Industries, Inc., NDC 47335-070-30. The carton is labeled for 30 film-coated tablets for oral use. It includes warnings, dosage instructions, manufacturer Aizant Drug Research Solutions Pvt. Ltd. Hyderabad, India, and distributor Sun Pharmaceutical Industries, Cranbury, NJ. Barcodes and a non-varnish area are visible.*

FDA Label Image

Spl-maciten-tablets-structure (Spl Maciten Tablets Structure)

Chemical structure of Macitentan, shown as a 2D molecular diagram depicting its atoms and bonds, including bromine atoms and heterocyclic rings.*

FDA Label Image

Spl-macitentan-tablets-figure1 (Spl Macitentan Tablets Figure1)

A forest plot chart showing point estimates and 90% confidence intervals for the effects of interacting drugs Sildenafil, Cyclosporine-A, Ketoconazole, and Rifampin on Macitentan and its active metabolite. The chart includes recommendations for each drug interaction, indicating 'No dose adjustment' for Sildenafil and Cyclosporine-A and 'Avoid' for Ketoconazole and Rifampin.*

FDA Label Image

Spl-macitentan-tablets-figure2 (Spl Macitentan Tablets Figure2)

A Kaplan-Meier survival curve chart comparing the percentage of patients event-free over months from treatment start between Macitentan 10 mg and placebo groups. The chart shows higher event-free survival for Macitentan 10 mg with data points and a table of number at risk below for both groups over various months.*

FDA Label Image

Spl-macitentan-tablets-figure3 (Spl Macitentan Tablets Figure3)

Figure 3 presents a subgroup analysis from the SERAPHIN study evaluating Macitentan. It shows a forest plot of hazard ratios with 95% confidence intervals for various patient characteristics, including age, sex, race, etiology, geographic region, and baseline measures, comparing Macitentan versus placebo in terms of treatment effect on the primary endpoint.*

FDA Label Image

Spl-macitentan-tablets-figure4 (Spl Macitentan Tablets Figure4)

A Kaplan-Meier survival curve graph comparing the percentage of patients event-free over months from treatment start between Macitentan 10 mg and placebo groups. The graph includes a survival percentage scale from 0 to 100 on the vertical axis and treatment duration up to 36 months on the horizontal axis. Macitentan shows higher event-free survival (70.63%) compared to placebo (55.10%) at the study endpoint. Risk numbers at different time points are shown below the graph.*

* 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.