Package 66215-812-08

{"route": ["ORAL"], "spl_id": "32840e17-39b6-50b2-e063-6394a90a7a37", "openfda": {"nui": ["N0000175599", "N0000020026", "N0000175581", "N0000175364"], "unii": ["742SXX0ICT", "Z9K9Y9WMVL"], "rxcui": ["2677765", "2677771", "2677773", "2677775"], "spl_set_id": ["6945b183-18d3-40de-afd1-c88e33cc1a63"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]", "Endothelin Receptor Antagonist [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]", "Endothelin Receptor Antagonists [MoA]"], "manufacturer_name": ["Actelion Pharmaceuticals US, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (66215-812-07)  / 7 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "66215-812-07", "marketing_start_date": "20240322"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (66215-812-08)  / 7 TABLET, FILM COATED in 1 BLISTER PACK (66215-812-01)", "package_ndc": "66215-812-08", "marketing_start_date": "20240322"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (66215-812-30)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "66215-812-30", "marketing_start_date": "20240322"}], "brand_name": "OPSYNVI", "product_id": "66215-812_32840e17-39b6-50b2-e063-6394a90a7a37", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Endothelin Receptor Antagonist [EPC]", "Endothelin Receptor Antagonists [MoA]", "Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "66215-812", "generic_name": "macitentan and tadalafil", "labeler_name": "Actelion Pharmaceuticals US, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OPSYNVI", "active_ingredients": [{"name": "MACITENTAN", "strength": "10 mg/1"}, {"name": "TADALAFIL", "strength": "20 mg/1"}], "application_number": "NDA218490", "marketing_category": "NDA", "marketing_start_date": "20240322", "listing_expiration_date": "20261231"}