Ipratropium Bromide
Ipratropium Bromide Inhalation Solution 0.02%
Approved
Approval ID
22479633-624a-4251-ad3c-1dcba5d503fb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
Ritedose Pharmaceuticals, LLC
DUNS: 968062294
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 Code76204-100
Application NumberANDA075693
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ipratropium Bromide
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 20, 2023
FDA Product Classification
INGREDIENTS (4)
IPRATROPIUM BROMIDEActive
Quantity: 0.5 mg in 2.5 mL
Code: J697UZ2A9J
Classification: ACTIR
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT