NDC product

BREZTRI

NDC 0310-4616 · AstraZeneca Pharmaceuticals LP

Key facts

Product NDC 0310-4616
Proprietary name BREZTRI
Nonproprietary name budesonide, glycopyrrolate, and formoterol fumarate
Substances BUDESONIDE, GLYCOPYRROLATE, FORMOTEROL
Dosage form AEROSOL, METERED
Route RESPIRATORY (INHALATION)
Labeler AstraZeneca Pharmaceuticals LP
Product type HUMAN PRESCRIPTION DRUG
Marketing category NDA
Application number NDA212122
Pharmacologic classes Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA] and 2 more
Marketing start Jul 23, 2020
Listing certified through Dec 31, 2027

At a glance

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About National Drug Codes (NDC)

The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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