Ipratropium Bromide and Albuterol Sulfate
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution 0.5 mg / 3 mg per 3 mL<BR><BR>Rx Only
Approved
Approval ID
89d59bd9-c826-413c-8ed9-a1521a0c7cc5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2024
Manufacturers
FDA
Cipla USA Inc.
DUNS: 078719707
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 Code69097-840
Application NumberANDA202496
Marketing CategoryC73584
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateFebruary 17, 2022
Generic NameIpratropium Bromide and Albuterol Sulfate
INGREDIENTS (5)
IPRATROPIUM BROMIDEActive
Quantity: 0.5 mg in 3 mL
Code: J697UZ2A9J
Classification: ACTIR
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALBUTEROL SULFATEActive
Quantity: 2.5 mg in 3 mL
Code: 021SEF3731
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT