Macitentan Tablet, Film Coated
Product Images NDC 69238-1327

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Macitentan (NDC 69238-1327). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amneal Pharmaceuticals Ny 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

S (Macitentan Tablets 10 mg 1)

Chemical structure of Macitentan, showing its molecular framework with bromophenyl, sulfonamide, and triazole groups evident in the diagram.*

FDA Label Image

1 (Macitentan Tablets 10 mg 2)

A comparative chart showing interaction effects of various drugs (Sildenafil, Cyclosporine-A, Ketoconazole, Rifampin) on Macitentan and its active metabolite. It displays changes relative to Macitentan alone in pharmacokinetic parameters AUC and Cmax or Ctrough with point estimates and 90% confidence intervals.*

FDA Label Image

2 (Macitentan Tablets 10 mg 3)

A Kaplan-Meier survival curve comparing the percentage of patients event free over 36 months from treatment start for Macitentan 10 mg oral tablets versus placebo. The graph shows Macitentan 10 mg with higher event-free survival (63.18%) compared to placebo (47.04%). Number of patients at risk is detailed below the x-axis.*

FDA Label Image

5 (Macitentan Tablets 10 mg 4)

A forest plot displaying hazard ratios with 95% confidence intervals for treatment effects of Macitentan versus placebo across various patient subgroups in a clinical study. Variables include age, sex, race, PAH etiology, concomitant PAH therapy, WHO functional class, geographical region, and walk test distance at baseline. The plot indicates the relative risk favoring Macitentan or placebo for each subgroup.*

FDA Label Image

6 (Macitentan Tablets 10 mg 5)

Kaplan-Meier survival curve chart comparing percentage of patients event-free over months from treatment start for Macitentan 10 mg tablets versus placebo. The chart shows higher event-free survival for Macitentan across approximately 36 months, with hazard ratio and confidence interval statistics included in the figure.*

FDA Label Image

1 (Macitentan Tablets 10 mg 6)

Label for Macitentan Tablets 10 mg film-coated tablets by Amneal Pharmaceuticals NY LLC. The label states prescription use only and includes directions to take one 10 mg tablet orally daily. The package contains 30 tablets. Storage instructions and manufacturing details from Amneal Pharmaceuticals LLC in Bridgewater, NJ, and a manufacturer in Ahmedabad, India, are also visible.*

FDA Label Image

2 (Macitentan Tablets 10 mg 7)

Macitentan 10 mg film-coated tablets label for oral use by Amneal Pharmaceuticals NY LLC. The label includes the product name, strength, NDC 69238-1327, pharmacist instructions, storage conditions, manufacturer and distributor information, barcode, and a 30-tablet count. The label also notes the prescription-only status and provides a Medication Guide dispensing reminder.*

* 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.