Atrovent
Atrovent (ipratropium bromide)Nasal Spray0.03%21mcg/spray
Approved
Approval ID
fa419d1b-092a-429f-850d-ad49c55b632f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 10, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-5565
Application NumberNDA020393
Product Classification
M
Marketing Category
C73594
G
Generic Name
ipratropium bromide
Product Specifications
Route of AdministrationNASAL
Effective DateNovember 22, 2010
FDA Product Classification
INGREDIENTS (7)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
IPRATROPIUM BROMIDEActive
Quantity: 21 ug in 1 1
Code: J697UZ2A9J
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT