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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5829
Application NumberNDA022064
Product Classification
M
Marketing Category
C73594
G
Generic Name
levocetirizine dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 11, 2010
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6115
Application NumberNDA022157
Product Classification
M
Marketing Category
C73594
G
Generic Name
levocetirizine dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 11, 2010
FDA Product Classification
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