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)

Chemical structure of macitentan, displaying its molecular framework including sulfonamide, bromophenyl, and heterocyclic ring components as depicted in the image.*

FDA Label Image

Figure1.jpg (Figure1)

A chart depicting the effect of interacting drugs (Sildenafil, Cyclosporine-A, Ketoconazole, Rifampin) on macitentan and its active metabolite. It shows point estimates and 90% confidence intervals for pharmacokinetic parameters (AUC and Cmax) indicating changes relative to macitentan alone.*

FDA Label Image

Figure2.jpg (Figure2)

A Kaplan-Meier survival curve chart comparing the percentage of patients event-free over time between macitentan 10 mg and placebo groups. The x-axis shows months from treatment start up to 36 months, and the y-axis shows the percent of patients event-free. Macitentan demonstrates a higher event-free rate than placebo throughout the period, with final values around 63% versus 47%. Statistical details including hazard ratio, confidence interval, and p-value are noted on the graph.*

FDA Label Image

Figure3.jpg (Figure3)

A forest plot chart showing hazard ratios with 95% confidence intervals for various patient characteristics comparing macitentan versus placebo treatment effects. It includes categories such as age, sex, race, PAH etiology, concomitant PAH therapy, WHO functional class, geographical region, and baseline walk test, indicating which subgroups favor macitentan or placebo.*

FDA Label Image

Figure4.jpg (Figure4)

This Kaplan-Meier survival curve compares the percentage of patients event-free over 36 months, contrasting Macitentan 10 mg with placebo. The graph shows higher event-free survival for Macitentan 10 mg, with 70.63% at the end versus 55.40% for placebo. The x-axis represents months from treatment start; the y-axis represents the percentage of patients event-free. A risk table below indicates patient numbers at various time points.*

FDA Label Image

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

Packaging label for Macitentan Tablets 10 mg oral film-coated tablets by Apotex Corp. The carton contains 15 unit-dose tablets. The label includes dosing instructions, storage conditions, and directions for pharmacist use, indicating hospital use only. Manufacturer information lists Apotex Inc. in Toronto, Canada, and Apotex Corp. in Weston, Florida.*

FDA Label Image

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

The packaging label for Macitentan Tablets 10 mg, film-coated oral tablets, displays a quantity of 30 tablets. The label includes dosage information, storage instructions, and warnings, with clear branding from Apotex Corp. The NDC number 60505-4644-3 is visible along with a barcode.*

FDA Label Image

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

Packaging label for Macitentan Tablets 10 mg film-coated oral tablets by Apotex Corp. The carton is designed for a bottle of 30 tablets. The label includes the proprietary and generic name 'Macitentan Tablets,' dosage strength 10 mg, and instructions to dispense the enclosed medication guide. It also displays NDC 60505-4644-3 and manufacturer information for Apotex Inc. (Toronto, Ontario) and Apotex Corp. (Weston, Florida).*

* 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.