Ipratropium Bromide
Approved
Approval ID
46b4392a-47dd-47b5-9f99-13e4c188faa4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 29, 2010
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 Code21695-911
Application NumberANDA076291
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ipratropium Bromide
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 14, 2007
FDA Product Classification
INGREDIENTS (4)
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
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT