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
2042b8be-c8c1-418e-ad48-851ea61b2726
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2020
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-2591
Application NumberANDA203027
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levocetirizine Dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2019
FDA Product Classification
INGREDIENTS (9)
LEVOCETIRIZINE DIHYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: SOD6A38AGA
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
Polyethylene Glycol 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT