breztri

Generic: budesonide, glycopyrrolate, and formoterol fumarate

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

Drug Facts

Product Profile

Brand Name breztri
Generic Name budesonide, glycopyrrolate, and formoterol fumarate
Labeler astrazeneca pharmaceuticals lp
Dosage Form AEROSOL, METERED
Routes
RESPIRATORY (INHALATION)
Active Ingredients

budesonide 160 ug/1, formoterol 4.8 ug/1, glycopyrrolate 9 ug/1

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0310-4616
Product ID 0310-4616_27dfdc47-2b38-4df9-b2a1-102a6dd7256d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212122
Listing Expiration 2026-12-31
Marketing Start 2020-07-23

Pharmacologic Class

Established (EPC)
corticosteroid [epc] beta2-adrenergic agonist [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa] adrenergic beta2-agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03104616
Hyphenated Format 0310-4616

Supplemental Identifiers

RxCUI
2387326 2387328 2387329 2387331
UNII
Q3OKS62Q6X 5ZZ84GCW8B V92SO9WP2I
NUI
N0000175576 N0000175450 N0000009922 N0000175779

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 breztri (source: ndc)
Generic Name budesonide, glycopyrrolate, and formoterol fumarate (source: ndc)
Application Number NDA212122 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 160 ug/1
  • 4.8 ug/1
  • 9 ug/1
source: ndc
Packaging
  • 120 AEROSOL, METERED in 1 INHALER (0310-4616-12)
  • 28 AEROSOL, METERED in 1 INHALER (0310-4616-28)
  • 28 AEROSOL, METERED in 1 INHALER (0310-4616-39)
source: ndc

Packages (3)

0310-4616-12 120 AEROSOL, METERED in 1 INHALER (0310-4616-12) 0310-4616-28 28 AEROSOL, METERED in 1 INHALER (0310-4616-28) 0310-4616-39 28 AEROSOL, METERED in 1 INHALER (0310-4616-39)

Ingredients (3)

budesonide (160 ug/1) formoterol (4.8 ug/1) glycopyrrolate (9 ug/1)

Linked Drug Pages (1)

BREZTRI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "27dfdc47-2b38-4df9-b2a1-102a6dd7256d", "openfda": {"nui": ["N0000175576", "N0000175450", "N0000009922", "N0000175779"], "unii": ["Q3OKS62Q6X", "5ZZ84GCW8B", "V92SO9WP2I"], "rxcui": ["2387326", "2387328", "2387329", "2387331"], "spl_set_id": ["715433dc-cb2b-43ea-b6df-c5b4177adc6c"], "pharm_class_epc": ["Corticosteroid [EPC]", "beta2-Adrenergic Agonist [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Adrenergic beta2-Agonists [MoA]"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 AEROSOL, METERED in 1 INHALER (0310-4616-12)", "package_ndc": "0310-4616-12", "marketing_start_date": "20200723"}, {"sample": true, "description": "28 AEROSOL, METERED in 1 INHALER (0310-4616-28)", "package_ndc": "0310-4616-28", "marketing_start_date": "20200723"}, {"sample": false, "description": "28 AEROSOL, METERED in 1 INHALER (0310-4616-39)", "package_ndc": "0310-4616-39", "marketing_start_date": "20200723"}], "brand_name": "BREZTRI", "product_id": "0310-4616_27dfdc47-2b38-4df9-b2a1-102a6dd7256d", "dosage_form": "AEROSOL, METERED", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "0310-4616", "generic_name": "budesonide, glycopyrrolate, and formoterol fumarate", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BREZTRI", "active_ingredients": [{"name": "BUDESONIDE", "strength": "160 ug/1"}, {"name": "FORMOTEROL", "strength": "4.8 ug/1"}, {"name": "GLYCOPYRROLATE", "strength": "9 ug/1"}], "application_number": "NDA212122", "marketing_category": "NDA", "marketing_start_date": "20200723", "listing_expiration_date": "20261231"}