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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53217-375
Application NumberANDA203027
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levocetirizine Dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 23, 2018
FDA Product Classification
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