CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE SYRUP For Oral Use Rx only
Approved
Approval ID
cd989627-71ff-479d-a103-c1a22aa9e5e2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 26, 2010
Manufacturers
FDA
WOCKHARDT LLC.
DUNS: 170508365
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 Code64679-693
Application NumberANDA078757
Product Classification
M
Marketing Category
C73584
G
Generic Name
CETIRIZINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateApril 27, 2010
FDA Product Classification
INGREDIENTS (11)
CETIRIZINE HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 64O047KTOA
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM ACETATE ANHYDROUSInactive
Code: NVG71ZZ7P0
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
GRAPEInactive
Code: 6X543N684K
Classification: IACT
BANANAInactive
Code: 4AJZ4765R9
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT