Package 66215-501-15
Brand: opsumit
Generic: macitentanPackage Facts
Identity
Package NDC
66215-501-15
Digits Only
6621550115
Product NDC
66215-501
Description
1 BLISTER PACK in 1 CARTON (66215-501-15) / 15 TABLET, FILM COATED in 1 BLISTER PACK
Marketing
Marketing Status
Brand
opsumit
Generic
macitentan
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "3282790e-e454-3214-e063-6294a90a526b", "openfda": {"nui": ["N0000175581", "N0000175364"], "unii": ["Z9K9Y9WMVL"], "rxcui": ["1442137", "1442143"], "spl_set_id": ["1e484a50-55db-4b85-8c57-6cd1b0353abd"], "pharm_class_epc": ["Endothelin Receptor Antagonist [EPC]"], "pharm_class_moa": ["Endothelin Receptor Antagonists [MoA]"], "manufacturer_name": ["Actelion Pharmaceuticals US, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (66215-501-15) / 15 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "66215-501-15", "marketing_start_date": "20131104"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (66215-501-30) / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "66215-501-30", "marketing_start_date": "20131104"}], "brand_name": "OPSUMIT", "product_id": "66215-501_3282790e-e454-3214-e063-6294a90a526b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Endothelin Receptor Antagonist [EPC]", "Endothelin Receptor Antagonists [MoA]"], "product_ndc": "66215-501", "generic_name": "macitentan", "labeler_name": "Actelion Pharmaceuticals US, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OPSUMIT", "active_ingredients": [{"name": "MACITENTAN", "strength": "10 mg/1"}], "application_number": "NDA204410", "marketing_category": "NDA", "marketing_start_date": "20131104", "listing_expiration_date": "20261231"}