Macitentan Tablet, Film Coated
Product Images NDC 59651-147

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Macitentan (NDC 59651-147). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma 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.

Product Images & Figures Index

FDA Label Image

Figure-1 (Macitentan Fig1)

Figure-1 (Macitentan Fig1)
This information provides data on the interactions of sildenafil, cyclosporine-A, ketoconazole, rifampin, and macitentan with other drugs in terms of their pharmacokinetic parameters such as Crmax, AUCtau, Cimax, AUCtu, and Ctrough. The text also includes point estimates and 90% confidence intervals for comparing the drugs alone versus in combination. It seems to be discussing the impact of these interactions on the relative change in efficacy or safety of macitentan when administered with the mentioned drugs.*
FDA Label Image

Figure-2 (Macitentan Fig2)

Figure-2 (Macitentan Fig2)
FDA Label Image

Figure-3 (Macitentan Fig3)

Figure-3 (Macitentan Fig3)
This text provides a detailed analysis of hazard ratios (HR) in a study evaluating different factors such as age, sex, race, PAH etiology, concomitant PAH therapy, WHO functional class at baseline, geographical region, and walk test results in relation to treatment effect for macitentan compared to placebo. The results are presented for each factor as compared with overall treatment effect for the primary endpoint. The data also includes specific subgroups such as age groups, sex, race, PAH etiology, and other relevant variables, with corresponding hazard ratios and confidence intervals. Ultimately, the text highlights the impact of these various factors on the efficacy of macitentan versus placebo.*
FDA Label Image

Figure-4 (Macitentan Fig4)

Figure-4 (Macitentan Fig4)
This text provides information about a clinical trial involving Macitentan 10 mg and a placebo. The hazard ratio for Macitentan is 0.500 with a 97.5% confidence interval of (0.335, 0.747). The logrank p-value is shown as <.0001. The data also includes the number at risk over different months from treatment start for both Macitentan and placebo groups.*
FDA Label Image

Package Label-principal Display Panel (10 mg (30 Tablets Bottle))

Package Label-principal Display Panel (10 mg (30 Tablets Bottle))
This is a description of a pharmaceutical product containing 10 mg of macitentan distributed by Aurobindo Pharma USA, Inc. Each film-coated tablet should be taken once a day. The tablets should be stored at 25°C. Pharmacists are advised to dispense the medication and provide a medication guide to each patient. Parents should keep this medication out of the reach of children. More information can be found on the website www.aurobindousa.com/medication-guides.*
FDA Label Image

Chemical Structure (Macitentan Str)

Chemical Structure (Macitentan Str)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.