Levocetirizine Dihydrochloride
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . tablets, for oral use Initial U.S. Approval: 1995
Approved
Approval ID
1efcf912-1187-4d69-895c-30d363e5eb7a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 23, 2018
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
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 Code53217-375
Application NumberANDA203027
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 23, 2018
Generic NameLevocetirizine Dihydrochloride
INGREDIENTS (9)
LEVOCETIRIZINE DIHYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: SOD6A38AGA
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT