cetirizine hydrochloride
Approved
Approval ID
23f3ec1c-bbba-49ef-b7d6-0be6e9424b99
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 2, 2009
Manufacturers
FDA
Caraco Pharmaceutical Laboratories, Ltd.
DUNS: 146974886
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
cetirizine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57664-181
Application NumberANDA090191
Product Classification
M
Marketing Category
C73584
G
Generic Name
cetirizine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 11, 2009
FDA Product Classification
INGREDIENTS (9)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
CETIRIZINE HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 64O047KTOA
Classification: ACTIB
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT