Macitentan Tablet, Film Coated
Product Images NDC 82293-041
View Photos of Packaging, Regulatory Labels, and Product Appearance
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.
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This is a data report from a study evaluating the characteristic hazard ratio for different subgroups in a clinical trial comparing the treatment effects of Macitentan versus Placebo. The data includes information on primary endpoints, age groups, gender, race, PAH etiology, concomitant PAH therapy, WHO functional class, geographical region, and walk test results. The hazard ratios are presented with 96% confidence intervals. The results indicate the impact of these factors on the treatment efficacy.*
Figure (05)
Blister Carton (Image1)
This is a description of Macitentan Tablets, 10 mg, intended for hospital use only. Each film-coated tablet contains Macitentan 10 mg and the usual dosage is one tablet per day. The tablets should be stored at 20-25°C (68-77°F). It is advised to keep the medication out of the reach of children. The packaging is a unit-dose pack, not child-resistant. If dispensed for outpatient use, only a 15-day supply should be given in a child-resistant container. The tablets are distributed by Novugen Pharma (USA) LLC and manufactured by Haimen Pharma Inc.*
Blister (Image2)
Bottle Label (Label01)
This text provides information about a medication with the NDC number 82293-041-20. It contains Macitentan 10 mg in film-coated tablets with a recommended dosage of one tablet daily. The text also advises to keep the medication out of reach of children and provides storage instructions between 20°C to 25°C. Additionally, it suggests dispensing a Medication Guide to each patient and mentions permissible temperature excursions.*
Bottle Label (Label2)
This is a description of a medication with NDC 82293-041-30, containing Macitentan 10 mg in film-coated tablets. The usual dosage recommended is one 10 mg tablet per day. It is important to store the medication between 20°C to 25°C (68°F to 77°F) and to keep it out of reach of children. The pharmacist should dispense the medication along with the Medication Guide to each patient.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.