FDA.reportPublic FDA data

Levocetirizine Dihydrochloride

Product NDC
71335-1305
11-digit product format
713351305
Labeler code
71335
Product ID
71335-1305_3214c803-6a3c-40c3-ab29-1088452d7788
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levocetirizine Dihydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202046
Marketing category
ANDA
Marketing start
2013-09-30
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
71335-1305-12025-06-27C16284748780-11030e365-183a-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
71335-1305-22025-06-27C16284748780-11030e365-183a-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
71335-1305-32025-06-27C16284748780-11030e365-183a-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
71335-1305-42025-06-27C16284748780-11030e365-183a-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
71335-1305-12024-01-30C16284748780-11030e365-183a-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
71335-1305-22024-01-30C16284748780-11030e365-183a-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
71335-1305-32024-01-30C16284748780-11030e365-183a-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
71335-1305-42024-01-30C16284748780-11030e365-183a-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
71335-1305-1Levocetirizine Dihydrochloride30 in 1 BOTTLETABLET, FILM COATED303
71335-1305-2Levocetirizine Dihydrochloride90 in 1 BOTTLETABLET, FILM COATED903
71335-1305-3Levocetirizine Dihydrochloride28 in 1 BOTTLETABLET, FILM COATED283
71335-1305-4Levocetirizine Dihydrochloride60 in 1 BOTTLETABLET, FILM COATED603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1305LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]2Current NDC, Legacy NDC, 4 package rows20220204_e885f084-9ce2-4e0c-aadb-c9d651224e5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSNe885f084-9ce2-4e0c-aadb-c9d651224e5b3
855172levocetirizine dihydrochloride 5 MG Oral TabletSCDe885f084-9ce2-4e0c-aadb-c9d651224e5b3
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSYe885f084-9ce2-4e0c-aadb-c9d651224e5b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1305-17133513050130 TABLET, FILM COATED in 1 BOTTLE (71335-1305-1) 2019-09-050000-00-00NoNoCurrent
71335-1305-27133513050290 TABLET, FILM COATED in 1 BOTTLE (71335-1305-2) 2021-03-090000-00-00NoNoCurrent
71335-1305-37133513050328 TABLET, FILM COATED in 1 BOTTLE (71335-1305-3) 2025-06-270000-00-00NoNoCurrent
71335-1305-47133513050460 TABLET, FILM COATED in 1 BOTTLE (71335-1305-4) 2025-06-270000-00-00NoNoCurrent