Macitentan Tablet, Film Coated
Product Images NDC 82293-041

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Macitentan (NDC 82293-041). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Novugen Pharma (usa) Llc, 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

Structure (01)

Chemical structure diagram of macitentan, showing its molecular composition including bromine-substituted aromatic rings and other functional groups.*

FDA Label Image

Figure (02)

A comparative chart showing point estimates and 90% confidence intervals for macitentan and its active metabolite when co-administered with interacting drugs sildenafil, cyclosporine-A, ketoconazole, and rifampin. The graph illustrates changes in AUC and Cmax or Ctrough relative to macitentan alone for each drug interaction.*

FDA Label Image

Figure (03)

This Kaplan-Meier survival curve chart compares the percentage of patients event-free over time between Macitentan 10 mg and placebo groups. The X-axis represents months from treatment start (0 to 36 months), and the Y-axis shows the percent of patients event-free. The solid line represents Macitentan 10 mg, and the dashed line represents placebo, with Macitentan showing a higher event-free percentage over time. A hazard ratio, confidence interval, and p-value are noted below the graph. A table below the chart lists the number of patients at risk at various time points for both groups.*

FDA Label Image

Figure (04)

A forest plot chart displaying hazard ratios for various subgroups comparing Macitentan versus placebo treatment effects, including age, sex, race, PAH etiology, PAH therapy, WHO functional class, geographical regions, and baseline walk test distance. The plot shows hazard ratios with 95% confidence intervals, indicating the effect size favoring either Macitentan or placebo.*

FDA Label Image

Figure (05)

A Kaplan-Meier survival curve chart showing the percentage of patients event-free over months from treatment start, comparing Macitentan 10 mg and placebo. The chart includes hazard ratio, confidence interval, and p-value, with a table of number at risk for each group over time.*

FDA Label Image

Blister Carton (Image1)

Label for Macitentan Tablets 10 mg film-coated oral tablets, distributed by Novugen Pharma (USA) LLC. The label indicates packaging contains 15 tablets in unit-dose form, for hospital use only. Storage instructions and manufacturer information (Haimen Pharma Inc., China) are included. The label also notes the product is Rx only and provides a barcode.*

FDA Label Image

Blister (Image2)

Sheet of multiple labels for Macitentan Tablet 10 mg film-coated tablets, distributed by Novugen Pharma (USA) LLC. Each label shows the NDC 82293-041-10, indicates prescription-only and hospital use, includes a barcode, and has space for batch number and expiration date.*

FDA Label Image

Bottle Label (Label01)

Label for Macitentan Tablets 10 mg, film-coated oral tablets supplied in a package of 30 tablets. The label includes the NDC 82293-041, with storage instructions and distribution information by Novugen Pharma (USA) LLC. The label states the strength as 10 mg and indicates the medication is prescription only.*

FDA Label Image

Bottle Label (Label2)

Packaging label for Macitentan Tablets 10 mg film-coated tablets by Novugen Pharma (USA) LLC. The label indicates a 100-tablet bottle with an oral prescription drug containing 10 mg of macitentan per tablet. Instructions include storage conditions and a caution to keep out of children's reach. The product is made in China.*

* 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.