Levocetirizine dihydrochloride
These highlights do not include all the information needed to use levocetirizine dihydrochloride tablets safely and effectively. See full prescribing information for levocetirizine dihydrochloride tablets. Levocetirizine dihydrochloride 5 mg tablets Initial U.S. Approval: 1995
Approved
Approval ID
8d416349-161d-4232-b6b4-e75214ea4841
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 5, 2011
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.
Levocetirizine dihydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-2077
Application NumberANDA090229
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levocetirizine dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 22, 2011
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LEVOCETIRIZINE DIHYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: SOD6A38AGA
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT