budesonide and formoterol fumarate dihydrate

Generic: budesonide and formoterol fumarate dihydrate

Labeler: sportpharm, inc. dba sportpharm
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name budesonide and formoterol fumarate dihydrate
Generic Name budesonide and formoterol fumarate dihydrate
Labeler sportpharm, inc. dba sportpharm
Dosage Form AEROSOL
Routes
RESPIRATORY (INHALATION)
Active Ingredients

budesonide 80 ug/1, formoterol fumarate 4.5 ug/1

Manufacturer
Sportpharm, Inc. dba Sportpharm

Identifiers & Regulatory

Product NDC 85766-113
Product ID 85766-113_43f4c6ec-3ae5-9192-e063-6394a90a837c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021929
Listing Expiration 2026-12-31
Marketing Start 2020-01-03

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85766113
Hyphenated Format 85766-113

Supplemental Identifiers

RxCUI
1246288 1246304
UNII
Q3OKS62Q6X W34SHF8J2K
NUI
N0000175576 N0000175450

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name budesonide and formoterol fumarate dihydrate (source: ndc)
Generic Name budesonide and formoterol fumarate dihydrate (source: ndc)
Application Number NDA021929 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 80 ug/1
  • 4.5 ug/1
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (85766-113-12) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER
source: ndc

Packages (1)

85766-113-12 1 POUCH in 1 CARTON (85766-113-12) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER

Ingredients (2)

budesonide (80 ug/1) formoterol fumarate (4.5 ug/1)

Linked Drug Pages (1)

Budesonide and Formoterol Fumarate Dihydrate ndc-match (0.9)

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"}