"66215-812-07" National Drug Code (NDC)

Opsynvi 1 BOTTLE in 1 CARTON (66215-812-07) / 7 TABLET, FILM COATED in 1 BOTTLE
(Actelion Pharmaceuticals US, Inc.)

NDC Code66215-812-07
Package Description1 BOTTLE in 1 CARTON (66215-812-07) / 7 TABLET, FILM COATED in 1 BOTTLE
Product NDC66215-812
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameOpsynvi
Non-Proprietary NameMacitentan And Tadalafil
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20240322
Marketing Category NameNDA
Application NumberNDA218490
ManufacturerActelion Pharmaceuticals US, Inc.
Substance NameMACITENTAN; TADALAFIL
Strength10; 20
Strength Unitmg/1; mg/1
Pharmacy ClassesEndothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA], Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]

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