Ipratropium Bromide
Ipratropium Bromide Inhalation Solution
Approved
Approval ID
95990ec1-9cfd-4b94-afbd-7ced6ecca567
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code42254-041
Application NumberANDA075693
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ipratropium Bromide
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateMarch 15, 2011
FDA Product Classification
INGREDIENTS (3)
IPRATROPIUM BROMIDEActive
Quantity: 0.5 mg in 2.5 mL
Code: J697UZ2A9J
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT