NDCFind

Breyna 00378-7503

Generic: Budesonide And Formoterol Fumarate

Product NDC

00378-7503
Manufacturer
Mylan Pharmaceuticals Inc.
Dosage Form
Aerosol, Metered
Route
Respiratory (inhalation)
Product Type
Human Prescription Drug
Marketing Start
July 31, 2023
Listing Expires
December 31, 2027
Application
ANDA211699
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Active Ingredients

IngredientStrength
Budesonide160 ug/1
Formoterol Fumarate4.5 ug/1

Drug Class

Corticosteroid [EPC]Adrenergic beta2-Agonists [MoA]Corticosteroid Hormone Receptor Agonists [MoA]

Packaging Options(1)

1 POUCH in 1 CARTON (0378-7503-32) / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER