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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-840
Application NumberANDA202496
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ipratropium Bromide and Albuterol Sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateFebruary 17, 2022
FDA Product Classification
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