ipratropium bromide and albuterol sulfate
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution
Approved
Approval ID
cb23ee12-3b8a-4776-bcc0-23f0da66edb3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2019
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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
NDC Product Code63187-529
Application NumberANDA202496
Marketing CategoryC73584
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateNovember 1, 2019
Generic Nameipratropium bromide and albuterol sulfate
INGREDIENTS (4)
ALBUTEROL SULFATEActive
Quantity: 2.5 mg in 3 mL
Code: 021SEF3731
Classification: ACTIM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
IPRATROPIUM BROMIDEActive
Quantity: 0.5 mg in 3 mL
Code: J697UZ2A9J
Classification: ACTIR
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT