FDA.reportPublic FDA data

Levocetirizine Dihydrochloride

Product NDC
68071-5107
11-digit product format
680715107
Labeler code
68071
Product ID
68071-5107_1b469ff6-52ec-a91b-e063-6394a90a3123
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levocetirizine Dihydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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
68071-5107-92024-06-19C16284748780-1ba0f9c33-2042-a910-e053-dadaa90a0b85These 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
68071-5107-92023-01-30C16284748780-1ba0f9c33-2042-a910-e053-dadaa90a0b85These 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
68071-5107-92021-02-22C16284748780-1ba0f9c33-2042-a910-e053-dadaa90a0b85These 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
68071-5107-92021-01-29C16284748780-1ba0f9c33-2042-a910-e053-dadaa90a0b85These 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
68071-5107-9Levocetirizine Dihydrochloride90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5107LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20240621_97a67686-7e94-dd77-e053-2995a90a42c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN97a67686-7e94-dd77-e053-2995a90a42c64
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD97a67686-7e94-dd77-e053-2995a90a42c64
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY97a67686-7e94-dd77-e053-2995a90a42c64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-5107-96807151070990 TABLET, FILM COATED in 1 BOTTLE (68071-5107-9) 2019-11-180000-00-00NoNoCurrent