Xopenex HFA
XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol
Approved
Approval ID
320fea02-8aa3-44c8-b52a-a118418d1f78
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 7, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
levalbuterol tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5689
Application NumberNDA021730
Product Classification
M
Marketing Category
C73594
G
Generic Name
levalbuterol tartrate
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2012
FDA Product Classification
INGREDIENTS (4)
norfluraneInactive
Code: DH9E53K1Y8
Classification: IACT
AlcoholInactive
Code: 3K9958V90M
Classification: IACT
Oleic AcidInactive
Code: 2UMI9U37CP
Classification: IACT
levalbuterol tartrateActive
Quantity: 45 ug in 1 1
Code: ADS4I3E22M
Classification: ACTIM