PULMICORT FLEXHALER
These highlights do not include all the information needed to use PULMICORT FLEXHALER™ safely and effectively. See full prescribing information for PULMICORT FLEXHALER PULMICORT FLEXHALER™ (budesonide) inhalation powderInitial U.S. Approval: 2006
Approved
Approval ID
10ea5d87-6ed0-4fa5-a37b-2043c8560bc0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Budesonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-6796
Application NumberNDA021949
Product Classification
M
Marketing Category
C73594
G
Generic Name
Budesonide
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 1, 2023
FDA Product Classification
INGREDIENTS (2)
BUDESONIDEActive
Quantity: 180 ug in 1 1
Code: Q3OKS62Q6X
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT