Ipratropium Bromide and Albuterol Sulfate
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP
Approved
Approval ID
3c64255e-074c-41f8-a344-3686a0685020
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 25, 2020
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 Code69097-173
Application NumberANDA077559
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ipratropium Bromide and Albuterol Sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateAugust 25, 2020
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ALBUTEROL SULFATEActive
Quantity: 2.5 mg in 3 mL
Code: 021SEF3731
Classification: ACTIM
IPRATROPIUM BROMIDEActive
Quantity: 0.5 mg in 3 mL
Code: J697UZ2A9J
Classification: ACTIR
WATERInactive
Code: 059QF0KO0R
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT