symbicort

Generic: budesonide and formoterol fumarate dihydrate

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name symbicort
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 50090-4509
Product ID 50090-4509_f086f511-6eb9-47f7-bf1b-8e04a70909be
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021929
Listing Expiration 2026-12-31
Marketing Start 2007-05-29

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 500904509
Hyphenated Format 50090-4509

Supplemental Identifiers

RxCUI
1246304 1246306
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 symbicort (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 (50090-4509-0) / 1 AEROSOL in 1 POUCH
source: ndc

Packages (1)

50090-4509-0 1 POUCH in 1 CARTON (50090-4509-0) / 1 AEROSOL in 1 POUCH

Ingredients (2)

budesonide (160 ug/1) formoterol fumarate (4.5 ug/1)

Linked Drug Pages (1)

SYMBICORT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "f086f511-6eb9-47f7-bf1b-8e04a70909be", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X", "W34SHF8J2K"], "rxcui": ["1246304", "1246306"], "spl_set_id": ["805764a1-65e1-4117-ac4a-7a54c3986cfe"], "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 (50090-4509-0)  / 1 AEROSOL in 1 POUCH", "package_ndc": "50090-4509-0", "marketing_start_date": "20190904"}], "brand_name": "SYMBICORT", "product_id": "50090-4509_f086f511-6eb9-47f7-bf1b-8e04a70909be", "dosage_form": "AEROSOL", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "50090-4509", "generic_name": "Budesonide and Formoterol Fumarate Dihydrate", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SYMBICORT", "active_ingredients": [{"name": "BUDESONIDE", "strength": "160 ug/1"}, {"name": "FORMOTEROL FUMARATE", "strength": "4.5 ug/1"}], "application_number": "NDA021929", "marketing_category": "NDA", "marketing_start_date": "20070529", "listing_expiration_date": "20261231"}