Ipratropium Bromide and Albuterol Sulfate
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP 0.5 mg/3 mg *Equivalent to 2.5 mg albuterol base
Approved
Approval ID
a03a3b08-23a8-401a-8305-057069962959
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2022
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-6288
Application NumberANDA207875
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ipratropium Bromide and Albuterol Sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 9, 2021
FDA Product Classification
INGREDIENTS (6)
IPRATROPIUM BROMIDEActive
Quantity: 0.5 mg in 3 mL
Code: J697UZ2A9J
Classification: ACTIR
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALBUTEROL SULFATEActive
Quantity: 2.5 mg in 3 mL
Code: 021SEF3731
Classification: ACTIM