Ipratropium Bromide and Albuterol Sulfate
Approved
Approval ID
8bcc115b-88da-4ff0-b4e1-ef10d5287e54
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 5, 2010
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.
Ipratropium Bromide and Albuterol Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5974
Application NumberNDA020950
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ipratropium Bromide and Albuterol Sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateNovember 5, 2010
FDA Product Classification
INGREDIENTS (5)
IPRATROPIUM BROMIDEActive
Quantity: 0.5 mg in 1 1
Code: J697UZ2A9J
Classification: ACTIB
ALBUTEROL SULFATEActive
Quantity: 3 mg in 1 1
Code: 021SEF3731
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT