levocetirizine dihydrochloride
These highlights do not include all the information needed to use LEVOCETIRIZINE DIHYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for LEVOCETIRIZINE DIHYDROCHLORIDE ORAL SOLUTION. LEVOCETIRIZINE DIHYDROCHLORIDE oral solutionInitial U.S. Approval: 1995
Approved
Approval ID
a9e7152c-0aa3-4355-8805-307e510ac86b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 26, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code72162-1424
Application NumberANDA091263
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 26, 2023
Generic NameLevocetirizine dihydrochloride
INGREDIENTS (9)
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
LEVOCETIRIZINE DIHYDROCHLORIDEActive
Quantity: 0.5 mg in 1 mL
Code: SOD6A38AGA
Classification: ACTIB
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
MALTITOLInactive
Code: D65DG142WK
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SACCHARINInactive
Code: FST467XS7D
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT