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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63187-529
Application NumberANDA202496
Product Classification
M
Marketing Category
C73584
G
Generic Name
ipratropium bromide and albuterol sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateNovember 1, 2019
FDA Product Classification
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