FDA.reportPublic FDA data

Levocetirizine Dihydrochloride

Product NDC
71335-0789
11-digit product format
713350789
Labeler code
71335
Product ID
71335-0789_4677b1a2-8516-44c2-9d61-0f033b40617c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocetirizine Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091264
Marketing category
ANDA
Marketing start
2012-06-29
Substance
LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levocetirizine Dihydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOCETIRIZINE DIHYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOD6A38AGA
Rxcui855172

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760Product name720190702

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0789-12025-03-28C16284748780-11030e365-116a-111a-e063-dadaa90a10e2These 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
71335-0789-22025-03-28C16284748780-11030e365-116a-111a-e063-dadaa90a10e2These 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
71335-0789-32025-03-28C16284748780-11030e365-116a-111a-e063-dadaa90a10e2These 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
71335-0789-42025-03-28C16284748780-11030e365-116a-111a-e063-dadaa90a10e2These 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
71335-0789-12024-01-30C16284748780-11030e365-116a-111a-e063-dadaa90a10e2These 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
71335-0789-22024-01-30C16284748780-11030e365-116a-111a-e063-dadaa90a10e2These 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
71335-0789-32024-01-30C16284748780-11030e365-116a-111a-e063-dadaa90a10e2These 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
71335-0789-42024-01-30C16284748780-11030e365-116a-111a-e063-dadaa90a10e2These 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0789-1Levocetirizine Dihydrochloride30 in 1 BOTTLETABLET306
71335-0789-2Levocetirizine Dihydrochloride90 in 1 BOTTLETABLET906
71335-0789-3Levocetirizine Dihydrochloride28 in 1 BOTTLETABLET286
71335-0789-4Levocetirizine Dihydrochloride60 in 1 BOTTLETABLET606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0789LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 4 package rows20250331_b7bbffcb-5f56-4735-998a-eadd07dfa2cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSNb7bbffcb-5f56-4735-998a-eadd07dfa2cb6
855172levocetirizine dihydrochloride 5 MG Oral TabletSCDb7bbffcb-5f56-4735-998a-eadd07dfa2cb6
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSYb7bbffcb-5f56-4735-998a-eadd07dfa2cb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0789-17133507890130 TABLET in 1 BOTTLE (71335-0789-1) 30 tablet2019-01-110000-00-00NoNoCurrent
71335-0789-27133507890290 TABLET in 1 BOTTLE (71335-0789-2) 90 tablet2018-05-170000-00-00NoNoCurrent
71335-0789-37133507890328 TABLET in 1 BOTTLE (71335-0789-3) 28 tablet2021-12-270000-00-00NoNoCurrent
71335-0789-47133507890460 TABLET in 1 BOTTLE (71335-0789-4) 60 tablet2021-12-270000-00-00NoNoCurrent