budesonide and formoterol fumarate dihydrate

Generic: budesonide and formoterol fumarate dihydrate

Labeler: astrazeneca pharmaceuticals lp
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 astrazeneca pharmaceuticals lp
Dosage Form AEROSOL
Routes
RESPIRATORY (INHALATION)
Active Ingredients

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

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0310-7372
Product ID 0310-7372_b500fba8-8294-4c20-b51e-2ce674acf1b3
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 03107372
Hyphenated Format 0310-7372

Supplemental Identifiers

RxCUI
1246288 1246304
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 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 (0310-7372-20) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER
source: ndc

Packages (1)

0310-7372-20 1 POUCH in 1 CARTON (0310-7372-20) / 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": "b500fba8-8294-4c20-b51e-2ce674acf1b3", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X", "W34SHF8J2K"], "rxcui": ["1246288", "1246304"], "spl_set_id": ["1d266fe8-52e3-4f85-a037-c5c1afa15e60"], "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 (0310-7372-20)  / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER", "package_ndc": "0310-7372-20", "marketing_start_date": "20200103"}], "brand_name": "Budesonide and Formoterol Fumarate Dihydrate", "product_id": "0310-7372_b500fba8-8294-4c20-b51e-2ce674acf1b3", "dosage_form": "AEROSOL", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "0310-7372", "generic_name": "Budesonide and Formoterol Fumarate Dihydrate", "labeler_name": "AstraZeneca Pharmaceuticals LP", "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"}