NDC 0378-7503

BREYNA

Budesonide And Formoterol Fumarate

BREYNA is a Respiratory (inhalation) Aerosol, Metered in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Budesonide; Formoterol Fumarate.

• Product ID: 0378-7503_dc529fc4-bddb-4673-8202-dc401f86166f
• NDC: 0378-7503
• Product Type: Human Prescription Drug
• Proprietary Name: BREYNA
• Generic Name: Budesonide And Formoterol Fumarate
• Dosage Form: Aerosol, Metered
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 2022-04-01
• Marketing Category: ANDA /
• Application Number: ANDA211699
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: BUDESONIDE; FORMOTEROL FUMARATE
• Active Ingredient Strength: 160 ug/1; ug/1
• Pharm Classes: Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Drug Details

NDC Crossover Matching brand name "BREYNA" or generic name "Budesonide And Formoterol Fumarate"

NDC	Brand Name	Generic Name
0378-7502	BREYNA	Budesonide and Formoterol Fumarate
0378-7503	BREYNA	Budesonide and Formoterol Fumarate