Package 0378-7502-32

Brand: breyna

Generic: budesonide and formoterol fumarate
NDC Package

Package Facts

Identity

Package NDC 0378-7502-32
Digits Only 0378750232
Product NDC 0378-7502
Description

1 POUCH in 1 CARTON (0378-7502-32) / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER

Marketing

Marketing Status
Marketed Since 2023-07-31
Brand breyna
Generic budesonide and formoterol fumarate
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "23e7ebd2-972d-49f0-95da-7e409da7fcae", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X", "W34SHF8J2K"], "rxcui": ["1246288", "1246304", "2597670", "2597673"], "spl_set_id": ["dc529fc4-bddb-4673-8202-dc401f86166f"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (0378-7502-32)  / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER", "package_ndc": "0378-7502-32", "marketing_start_date": "20230731"}], "brand_name": "BREYNA", "product_id": "0378-7502_23e7ebd2-972d-49f0-95da-7e409da7fcae", "dosage_form": "AEROSOL, METERED", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "0378-7502", "generic_name": "Budesonide and Formoterol Fumarate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BREYNA", "active_ingredients": [{"name": "BUDESONIDE", "strength": "80 ug/1"}, {"name": "FORMOTEROL FUMARATE", "strength": "4.5 ug/1"}], "application_number": "ANDA211699", "marketing_category": "ANDA", "marketing_start_date": "20230731", "listing_expiration_date": "20261231"}