PULMICORT
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™ 90 MCG, 180 MCG (BUDESONIDE INHALATION POWDER) Initial U.S. Approval: 2006
Approved
Approval ID
0950cd08-a48b-4376-9647-da22cf5a8a70
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 6, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-291
Application NumberNDA021949
Product Classification
M
Marketing Category
C73594
G
Generic Name
Budesonide
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJuly 29, 2010
FDA Product Classification
INGREDIENTS (2)
BUDESONIDEActive
Quantity: 90 ug in 1 1
Code: Q3OKS62Q6X
Classification: ACTIB
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT