Ipratropium Bromide
Ipratropium Bromide Inhalation Solution, 0.02%
Approved
Approval ID
db8095db-d1fd-4099-9fb1-d1ad4e284976
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2021
Manufacturers
FDA
Nephron Pharmaceuticals Corporation
DUNS: 079160190
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ipratropium Bromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0487-9801
Application NumberANDA075562
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ipratropium Bromide
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 11, 2021
FDA Product Classification
INGREDIENTS (4)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
IPRATROPIUM BROMIDEActive
Quantity: 0.5 mg in 2.5 mL
Code: J697UZ2A9J
Classification: ACTIR