BREYNA
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 2006
Approved
Approval ID
dc529fc4-bddb-4673-8202-dc401f86166f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 24, 2020
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Budesonide and Formoterol Fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-7502
Application NumberANDA211699
Product Classification
M
Marketing Category
C73584
G
Generic Name
Budesonide and Formoterol Fumarate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 24, 2020
FDA Product Classification
INGREDIENTS (5)
budesonideActive
Quantity: 80 ug in 1 1
Code: Q3OKS62Q6X
Classification: ACTIB
Formoterol FumarateActive
Quantity: 4.5 ug in 1 1
Code: W34SHF8J2K
Classification: ACTIB
polyethylene glycol 1000Inactive
Code: U076Q6Q621
Classification: IACT
apafluraneInactive
Code: R40P36GDK6
Classification: IACT
povidone k25Inactive
Code: K0KQV10C35
Classification: IACT
Budesonide and Formoterol Fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-7503
Application NumberANDA211699
Product Classification
M
Marketing Category
C73584
G
Generic Name
Budesonide and Formoterol Fumarate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 24, 2020
FDA Product Classification
INGREDIENTS (5)
Formoterol FumarateActive
Quantity: 4.5 ug in 1 1
Code: W34SHF8J2K
Classification: ACTIB
povidone k25Inactive
Code: K0KQV10C35
Classification: IACT
budesonideActive
Quantity: 160 ug in 1 1
Code: Q3OKS62Q6X
Classification: ACTIB
apafluraneInactive
Code: R40P36GDK6
Classification: IACT
polyethylene glycol 1000Inactive
Code: U076Q6Q621
Classification: IACT