Opsynvi Tablet, Film Coated
Product Images NDC 66215-814

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Opsynvi (NDC 66215-814). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Actelion Pharmaceuticals Us, 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.

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Chemical Structure (Opsynvi 01)

Chemical structure of macitentan, one of the active ingredients in OPSYNVI. The diagram shows the molecular connectivity including heterocyclic rings, bromine atoms, sulfonamide and ether functional groups.*

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Chemical Structure (Opsynvi 02)

Chemical structure diagram of macitentan, showing its molecular configuration with labeled atoms and bonds as commonly used in pharmaceutical chemistry.*

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Figure 1 (Opsynvi 03)

A forest plot chart showing fold change and 90% confidence intervals for the effect of coadministered drugs on various substrates, including CYP1A2, CYP2C9, CYP3A, P-glycoprotein, oral contraceptives, and NSAIDs. The horizontal axis represents change relative to coadministered drug alone, with recommendations on the right indicating no dose adjustment needed for all listed drugs.*

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Figure 2 (Opsynvi 04)

A two-part forest plot comparing OPSYNVI (macitentan and tadalafil) to macitentan 10 mg and tadalafil 40 mg across various subgroups including geographic region, region (US vs non-US), WHO Functional Class at baseline, age, sex, and race. The plots show geometric LS mean ratios with 95% confidence intervals, indicating effect sizes favoring either OPSYNVI or the comparator treatments.*

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Chart (Opsynvi 05)

A table titled "Acceptable birth control options" presenting four options for contraception methods. Each option lists specific birth control methods, such as intrauterine devices, hormonal contraceptives, diaphragms with spermicide, and condoms, detailing combinations and alternatives for acceptable use.*

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Principal Display Panel (10 mg/20 mg Tablet Bottle Carton)

The image displays the packaging label for OPSYNVI 10 mg/20 mg film-coated tablets containing macitentan and tadalafil. The label includes dosage information, storage instructions, and manufacturer details (Actelion Pharmaceuticals US, Inc.). The package contains 30 tablets and features tamper-evident areas, barcodes, and a medication guide notice. The product is indicated as prescription-only.*

FDA Label Image

Principal Display Panel (10 mg/40 mg Tablet Bottle Carton)

Packaging label for Opsynvi tablets containing macitentan 10 mg and tadalafil 40 mg. The label shows the brand name, active ingredients, strength, dosage form as film-coated tablets, and mentions the product is manufactured for Actelion Pharmaceuticals US, Inc. It includes warnings about storage temperature, child resistance, and instructions to dispense the medication guide. The package contains 30 tablets and displays several barcodes and a tamper-evident area.*

* 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.