Macitentan Tablet, Film Coated
Product Images NDC 70954-025

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Macitentan (NDC 70954-025). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ani Pharmaceuticals, Inc., 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

Blister (Blister)

Label panel for Macitentan 10 mg film-coated tablets by ANI Pharmaceuticals, Inc. The label notes 'For Hospital Use' with placeholders for expiration date and lot number, barcode, and distributor information indicating Baudette, MN 56623. The layout shows multiple repeated label sections, each specifying the strength as 10 mg and identifying the product as Macitentan tablets.*

FDA Label Image

Carton (Carton)

Macitentan Tablets 10 mg film-coated oral tablets packaging label by ANI Pharmaceuticals, Inc. The label displays the product name and strength prominently, the NDC 70954-025-20, package quantity of 15 tablets (1 x 15 Unit-Dose), and storage instructions. It includes a barcode, distributor address in Baudette, MN, and a warning to keep out of reach of children. The label states it is for hospital use only and prescribes to dispense the accompanying medication guide to patients.*

FDA Label Image

Container (Container)

Label for Macitentan Tablets 10 mg, film-coated oral tablets by ANI Pharmaceuticals, Inc. The label indicates a package of 30 tablets with the NDC 70954-025-10. Storage instructions, barcode, lot, expiration, serial number, and GTIN are included on the label.*

FDA Label Image

Figure1 (Figure1)

A chart displaying point estimates and 90% confidence intervals for the impact of interacting drugs (Sildenafil, Cyclosporine-A, Ketoconazole, Rifampin) on Macitentan and its active metabolite. The x-axis represents change relative to Macitentan alone, comparing parameters including AUC and Cmax for Macitentan and its active metabolite.*

FDA Label Image

Figuretwo (Figure2)

A Kaplan-Meier survival curve comparing the percentage of patients event-free over 36 months of treatment between Macitentan 10 mg and placebo groups. The graph shows higher event-free survival percentage for Macitentan 10 mg compared to placebo, with detailed number of patients at risk over time provided below the x-axis.*

FDA Label Image

Figure3 (Figure3)

A forest plot chart showing hazard ratios for various patient characteristics comparing Macitentan treatment to placebo. Characteristics include age, sex, race, PAH etiology, concomitant therapy, WHO functional class at baseline, geographical region, and walk test results. The chart visually represents favorability towards Macitentan or placebo for each subgroup with confidence intervals.*

FDA Label Image

Figure4 (Figure4)

A Kaplan-Meier survival curve comparing Macitentan 10 mg tablets versus placebo over 36 months from treatment start. The graph shows the percentage of patients event-free over time, with Macitentan maintaining a higher event-free rate (70.63%) compared to placebo (55.40%). A hazard ratio of 0.500 with a 97.5% confidence interval is noted, along with the number of patients at risk at various time points.*

FDA Label Image

Medguide (Medguide1)

Partial text listing possible side effects, including nausea, vomiting, stomach pain, tiredness, loss of appetite, yellowing skin or eyes, dark urine, fever, and itching. The text is incomplete and appears as bullet points.*

FDA Label Image

Structure (Structure)

Chemical structure of Macitentan, showing its molecular framework with sulfonamide, bromophenyl, and pyrimidine moieties.*

* 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.