Package 0310-4616-39
Brand: breztri
Generic: budesonide, glycopyrrolate, and formoterol fumaratePackage Facts
Identity
Package NDC
0310-4616-39
Digits Only
0310461639
Product NDC
0310-4616
Description
28 AEROSOL, METERED in 1 INHALER (0310-4616-39)
Marketing
Marketing Status
Brand
breztri
Generic
budesonide, glycopyrrolate, and formoterol fumarate
Sample Package
No
Linked Drug Pages (1)
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"}