Macitentan Tablet, Film Coated
Product Images NDC 46708-373

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Macitentan (NDC 46708-373). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Alembic Pharmaceuticals 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

30 Tablets (Macitentan 10mg)

Label for Macitentan Tablets 10 mg by Alembic Pharmaceuticals Limited. The film-coated tablets are prescription-only and supplied in a 30-tablet package. Storage instructions and manufacturer details from India are included, along with the NDC 46708-373-30 and barcode.*

FDA Label Image

Figure 1 (Macitentan Fig1)

A figure presenting the point estimate and 90% confidence interval for changes in Macitentan and its active metabolite levels when co-administered with interacting drugs (Sildenafil, Cyclosporine-A, Ketoconazole, Rifampin). The graph displays relative changes compared to Macitentan alone, highlighting AUC and Cmax or Ctrough parameters for each interacting drug.*

FDA Label Image

Figure 2 (Macitentan Figur2)

A Kaplan-Meier survival curve chart comparing the percentage of patients event free over time (in months) between Macitentan 10 mg and placebo groups. The chart shows higher event-free survival in the Macitentan 10 mg group compared to placebo over a 36-month period, with corresponding hazard ratio and confidence interval information included.*

FDA Label Image

Figure 3 (Macitentan Figur3)

A forest plot titled 'Subgroup Analysis of the SERAPHIN Study' showing hazard ratios for various patient subgroups comparing macitentan 10 mg to placebo. The plot includes categories such as age, sex, race, PAH etiology, WHO functional class, geographical region, and walk test distance, with confidence intervals indicating the effect size. Annotations define event and patient counts for macitentan and placebo groups.*

FDA Label Image

Figure 4 (Macitentan Figur4)

Kaplan-Meier survival curve chart showing percentage of patients event-free over 36 months from treatment start, comparing Macitentan 10 mg (solid line) and placebo (dashed line). The chart includes risk numbers at various time points and indicates higher event-free survival for Macitentan 10 mg versus placebo.*

FDA Label Image

Macitentan Structure (Macitentan Structure)

Chemical structure diagram of Macitentan showing its molecular composition and arrangement, including bromine atoms and functional groups typical to this active pharmaceutical ingredient.*

* 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.