Albuterol
AlbuterolInhalation Aerosol
Approved
Approval ID
29d24a6d-f9c1-4300-97c7-fec26bdbc22b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 20, 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.
Albuterol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-198
Application NumberANDA072273
Product Classification
M
Marketing Category
C73584
G
Generic Name
Albuterol
Product Specifications
Route of AdministrationORAL
Effective DateNovember 27, 2007
FDA Product Classification
INGREDIENTS (4)
AlbuterolActive
Quantity: 90 ug in 1 1
Code: QF8SVZ843E
Classification: ACTIB
TRICHLOROMONOFLUOROMETHANEInactive
Quantity: 60.9 mg in 1 1
Code: 990TYB331R
Classification: IACT
dichlorofluoromethaneInactive
Quantity: 25.97 mg in 1 1
Code: 7GAO4CRJ0B
Classification: IACT
oleic acidInactive
Quantity: 0.011 mg in 1 1
Code: 2UMI9U37CP
Classification: IACT