Xyzal
These highlights do not include all the information needed to use XYZAL safely and effectively. See full prescribing information for XYZAL. XYZAL (levocetirizine dihydrochloride) 5 mg tablets 2.5 mg/5 mL (0.5 mg/mL) oral solution Initial U.S. Approval: 1995
Approved
Approval ID
371ca86d-7ffd-4f20-b6c6-af0a9ff7362f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 11, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
levocetirizine dihydrochloride
PRODUCT DETAILS
NDC Product Code54868-5829
Application NumberNDA022064
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateMay 11, 2010
Generic Namelevocetirizine dihydrochloride
INGREDIENTS (6)
LEVOCETIRIZINE DIHYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: SOD6A38AGA
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
levocetirizine dihydrochloride
PRODUCT DETAILS
NDC Product Code54868-6115
Application NumberNDA022157
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateMay 11, 2010
Generic Namelevocetirizine dihydrochloride
INGREDIENTS (7)
LEVOCETIRIZINE DIHYDROCHLORIDEActive
Quantity: 0.5 mg in 1 mL
Code: SOD6A38AGA
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT