Package 85766-113-12

Brand: budesonide and formoterol fumarate dihydrate

Generic: budesonide and formoterol fumarate dihydrate
NDC Package

Package 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
Marketed Since 2025-10-31
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"}