NDC 0310-4616

BREZTRI

Budesonide, Glycopyrrolate, And Formoterol Fumarate

BREZTRI is a Respiratory (inhalation) Aerosol, Metered in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Budesonide; Glycopyrrolate; Formoterol.

• Product ID: 0310-4616_13ad4a6e-cfa4-4c95-a243-a4ebad234ed4
• NDC: 0310-4616
• Product Type: Human Prescription Drug
• Proprietary Name: BREZTRI
• Generic Name: Budesonide, Glycopyrrolate, And Formoterol Fumarate
• Dosage Form: Aerosol, Metered
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 2020-07-23
• Marketing Category: NDA / NDA
• Application Number: NDA212122
• Labeler Name: AstraZeneca Pharmaceuticals LP
• Substance Name: BUDESONIDE; GLYCOPYRROLATE; FORMOTEROL
• Active Ingredient Strength: 160 ug/1; ug/1; ug/1
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0310-4616-12

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

• Marketing Start Date: 2020-07-23
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details