levocetirizine dihydrochloride

Basic Information

Product Name

FDA Product Code

51655-564

Regulatory Information

NDC Product Code

51655-564

Application Number

ANDA203646

Marketing Category

C73584

Effective Date

January 1, 2023

Territorial Authority

USA

FDA Title

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 tablets, for oral use Initial U.S. Approval: 1995

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

LEVOCETIRIZINE DIHYDROCHLORIDE

Quantity: 5 mg in 1 1

Code: SOD6A38AGA

Class Code: ACTIB

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

Active Moieties

LEVOCETIRIZINE

Code: 6U5EA9RT2O

Basic Information

Regulatory Information

Company Information

Active Ingredients

POLYETHYLENE GLYCOL, UNSPECIFIED

MICROCRYSTALLINE CELLULOSE

LACTOSE MONOHYDRATE

SILICON DIOXIDE

TITANIUM DIOXIDE

HYPROMELLOSE, UNSPECIFIED

MAGNESIUM STEARATE

Active Moieties

LEVOCETIRIZINE