Ipratropium Bromide and Albuterol Sulfate
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg* Inhalation Solution
Approved
Approval ID
74170607-50c0-4de5-847e-64da9b1d52db
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2023
Manufacturers
FDA
Cardinal Health 107, LLC
DUNS: 118546603
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 Code55154-4357
Application NumberANDA076749
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ipratropium Bromide and Albuterol Sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 18, 2023
FDA Product Classification
INGREDIENTS (5)
IPRATROPIUM BROMIDEActive
Quantity: 0.5 mg in 3 mL
Code: J697UZ2A9J
Classification: ACTIR
ALBUTEROL SULFATEActive
Quantity: 3 mg in 3 mL
Code: 021SEF3731
Classification: ACTIM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT