Package 85766-113-12
Brand: budesonide and formoterol fumarate dihydrate
Generic: budesonide and formoterol fumarate dihydratePackage Facts
Identity
Package NDC
85766-113-12
Digits Only
8576611312
Product NDC
85766-113
Description
1 POUCH in 1 CARTON (85766-113-12) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER
Marketing
Marketing Status
Brand
budesonide and formoterol fumarate dihydrate
Generic
budesonide 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": "43f4c6ec-3ae5-9192-e063-6394a90a837c", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X", "W34SHF8J2K"], "rxcui": ["1246288", "1246304"], "spl_set_id": ["d6cc66c9-6f97-4ea8-a787-30a048004c77"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Sportpharm, Inc. dba Sportpharm"]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (85766-113-12) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER", "package_ndc": "85766-113-12", "marketing_start_date": "20251031"}], "brand_name": "Budesonide and Formoterol Fumarate Dihydrate", "product_id": "85766-113_43f4c6ec-3ae5-9192-e063-6394a90a837c", "dosage_form": "AEROSOL", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "85766-113", "generic_name": "Budesonide and Formoterol Fumarate Dihydrate", "labeler_name": "Sportpharm, Inc. dba Sportpharm", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Budesonide and Formoterol Fumarate Dihydrate", "active_ingredients": [{"name": "BUDESONIDE", "strength": "80 ug/1"}, {"name": "FORMOTEROL FUMARATE", "strength": "4.5 ug/1"}], "application_number": "NDA021929", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20200103", "listing_expiration_date": "20261231"}