symbicort

Generic: budesonide and formoterol fumarate dihydrate

Labeler: astrazeneca pharmaceuticals lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name symbicort
Generic Name budesonide and formoterol fumarate dihydrate
Labeler astrazeneca pharmaceuticals lp
Dosage Form AEROSOL
Routes
RESPIRATORY (INHALATION)
Active Ingredients

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

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0186-0370
Product ID 0186-0370_1f05ded1-7d31-4cfc-8537-0e75f99ad452
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 01860370
Hyphenated Format 0186-0370

Supplemental Identifiers

RxCUI
1246288 1246290 1246304 1246306 1246314 1246315 1246316 1246317
UNII
Q3OKS62Q6X W34SHF8J2K
NUI
N0000175576 N0000175450

Packaging Origin

Original Packager
true

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 (0186-0370-20) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER
  • 1 POUCH in 1 CARTON (0186-0370-28) / 1 CANISTER in 1 POUCH / 60 AEROSOL in 1 CANISTER
source: ndc

Packages (2)

0186-0370-20 1 POUCH in 1 CARTON (0186-0370-20) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER 0186-0370-28 1 POUCH in 1 CARTON (0186-0370-28) / 1 CANISTER in 1 POUCH / 60 AEROSOL in 1 CANISTER

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": "1f05ded1-7d31-4cfc-8537-0e75f99ad452", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X", "W34SHF8J2K"], "rxcui": ["1246288", "1246290", "1246304", "1246306", "1246314", "1246315", "1246316", "1246317"], "spl_set_id": ["fafa4cf1-99c2-43d5-73ad-51f256de3be0"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (0186-0370-20)  / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER", "package_ndc": "0186-0370-20", "marketing_start_date": "20070529"}, {"sample": false, "description": "1 POUCH in 1 CARTON (0186-0370-28)  / 1 CANISTER in 1 POUCH / 60 AEROSOL in 1 CANISTER", "package_ndc": "0186-0370-28", "marketing_start_date": "20070906"}], "brand_name": "SYMBICORT", "product_id": "0186-0370_1f05ded1-7d31-4cfc-8537-0e75f99ad452", "dosage_form": "AEROSOL", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "0186-0370", "generic_name": "Budesonide and Formoterol Fumarate Dihydrate", "labeler_name": "AstraZeneca Pharmaceuticals LP", "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"}