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 5 mg tablets Initial U.S. Approval: 1995
Approved
Approval ID
2f42fc80-ae39-4301-b140-36e59d71666e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 2010
Manufacturers
FDA
Synthon Pharmaceuticals, Inc.
DUNS: 013502302
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 Code63672-0051
Application NumberANDA090229
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levocetirizine dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 10, 2010
FDA Product Classification
INGREDIENTS (7)
Levocetirizine dihydrochlorideActive
Quantity: 5 mg in 1 1
Code: SOD6A38AGA
Classification: ACTIB
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
polyethylene glycol 400Inactive
Code: B697894SGQ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT