FDA.reportPublic FDA data

Levocetirizine Dihydrochloride

Product NDC
50090-1430
11-digit product format
500901430
Labeler code
50090
Product ID
50090-1430_26d1cd0e-482f-4296-961f-46c311479178
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocetirizine Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levocetirizine Dihydrochloride
Listing expiration
2027-12-31

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
50090-1430-02023-02-07C16284748780-1f386c64a-3140-0266-e053-dadaa90a7c1aThese 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
50090-1430-12023-02-07C16284748780-1f386c64a-3140-0266-e053-dadaa90a7c1aThese 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
50090-1430-02023-01-30C16284748780-1f386c64a-3140-0266-e053-dadaa90a7c1aThese 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
50090-1430-12023-01-30C16284748780-1f386c64a-3140-0266-e053-dadaa90a7c1aThese 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
50090-1430-0Levocetirizine Dihydrochloride30 in 1 BOTTLETABLET3015
50090-1430-1Levocetirizine Dihydrochloride90 in 1 BOTTLETABLET9015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1430-0EA - Each50090-14307bf3391b-aba2-4e24-ae3a-3a720b2758a612018-11-06
50090-1430-1EA - Each50090-1430bcbcf85e-9d4a-4cbd-9637-30394f8f4ad612018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1430LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]13Current NDC, Legacy NDC, 2 package rows20230926_d8b4b326-8be1-4404-9db7-636d86933139.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSNd8b4b326-8be1-4404-9db7-636d8693313915
855172levocetirizine dihydrochloride 5 MG Oral TabletSCDd8b4b326-8be1-4404-9db7-636d8693313915
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSYd8b4b326-8be1-4404-9db7-636d8693313915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1430-05009014300030 TABLET in 1 BOTTLE (50090-1430-0) 30 tablet2014-11-280000-00-00NoNoCurrent
50090-1430-15009014300190 TABLET in 1 BOTTLE (50090-1430-1) 90 tablet2015-05-110000-00-00NoNoCurrent