budesonide and formoterol fumarate dihydrate

Generic: budesonide and formoterol fumarate dihydrate

Labeler: a-s medication solutions
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 a-s medication solutions
Dosage Form AEROSOL
Routes
RESPIRATORY (INHALATION)
Active Ingredients

budesonide 160 ug/1, formoterol fumarate 4.5 ug/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6327
Product ID 50090-6327_dd1cf8de-0389-4e98-be80-dc164a6dbcff
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 500906327
Hyphenated Format 50090-6327

Supplemental Identifiers

RxCUI
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
  • 160 ug/1
  • 4.5 ug/1
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (50090-6327-0) / 1 AEROSOL in 1 POUCH
source: ndc

Packages (1)

50090-6327-0 1 POUCH in 1 CARTON (50090-6327-0) / 1 AEROSOL in 1 POUCH

Ingredients (2)

budesonide (160 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": "dd1cf8de-0389-4e98-be80-dc164a6dbcff", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X", "W34SHF8J2K"], "rxcui": ["1246304"], "spl_set_id": ["0ce4cd21-ac96-4b39-9e1c-49f86c87fa1a"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (50090-6327-0)  / 1 AEROSOL in 1 POUCH", "package_ndc": "50090-6327-0", "marketing_start_date": "20230112"}], "brand_name": "Budesonide and Formoterol Fumarate Dihydrate", "product_id": "50090-6327_dd1cf8de-0389-4e98-be80-dc164a6dbcff", "dosage_form": "AEROSOL", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "50090-6327", "generic_name": "Budesonide and Formoterol Fumarate Dihydrate", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Budesonide and Formoterol Fumarate Dihydrate", "active_ingredients": [{"name": "BUDESONIDE", "strength": "160 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"}