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. Initial U.S. Approval: 1995
Approved
Approval ID
c40c1bb4-25ce-90cb-b8dd-6a4c54cddd4a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2018
Manufacturers
FDA
Dr.Reddy's laboratories Ltd.
DUNS: 650562841
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
NDC Product Code55111-282
Application NumberANDA090392
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 6, 2018
Generic Namelevocetirizine dihydrochloride
INGREDIENTS (8)
levocetirizine dihydrochlorideActive
Quantity: 5 mg in 1 1
Code: SOD6A38AGA
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT