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 tablets, for oral useInitial U.S. Approval: 1995
Approved
Approval ID
60ae7e0e-281c-40a3-a0d3-259b843ddaaa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 28, 2020
Manufacturers
FDA
Glenmark Pharmaceuticals Inc., USA
DUNS: 130597813
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 Code68462-346
Application NumberANDA090385
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 28, 2020
Generic Namelevocetirizine dihydrochloride
INGREDIENTS (8)
MICROCRYSTALLINE CELLULOSEInactive
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
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT