Package 78206-125-01

Brand: dulera

Generic: mometasone furoate and formoterol fumarate dihydrate
NDC Package

Package Facts

Identity

Package NDC 78206-125-01
Digits Only 7820612501
Product NDC 78206-125
Description

1 CANISTER in 1 CARTON (78206-125-01) / 120 AEROSOL in 1 CANISTER

Marketing

Marketing Status
Marketed Since 2021-06-01
Brand dulera
Generic mometasone furoate and formoterol fumarate dihydrate
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "74079d8a-85a1-4736-8486-76624af02194", "openfda": {"unii": ["04201GDN4R", "W34SHF8J2K"], "rxcui": ["1246308", "1246310", "1246311", "1246313", "1660933", "1660934", "1660937", "1660938", "2196590", "2196592"], "spl_set_id": ["8f399784-f257-4f31-b3dc-368bf2a1864d"], "manufacturer_name": ["Organon LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CANISTER in 1 CARTON (78206-125-01)  / 120 AEROSOL in 1 CANISTER", "package_ndc": "78206-125-01", "marketing_start_date": "20210601"}, {"sample": true, "description": "1 CANISTER in 1 CARTON (78206-125-59)  / 120 AEROSOL in 1 CANISTER", "package_ndc": "78206-125-59", "marketing_start_date": "20210601"}], "brand_name": "Dulera", "product_id": "78206-125_74079d8a-85a1-4736-8486-76624af02194", "dosage_form": "AEROSOL", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "78206-125", "generic_name": "mometasone furoate and formoterol fumarate dihydrate", "labeler_name": "Organon LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dulera", "active_ingredients": [{"name": "FORMOTEROL FUMARATE", "strength": "5 ug/1"}, {"name": "MOMETASONE FUROATE", "strength": "50 ug/1"}], "application_number": "NDA022518", "marketing_category": "NDA", "marketing_start_date": "20210601", "listing_expiration_date": "20271231"}