FDA.reportPublic FDA data

LEVOCETIRIZINE DIHYDROCHLORIDE

Product NDC
70934-235
11-digit product format
709340235
Labeler code
70934
Product ID
70934-235_b7c3b6c1-4a42-fbb5-e053-2a95a90acbe2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOCETIRIZINE DIHYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA205564
Marketing category
ANDA
Marketing start
2019-01-15
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

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
70934-235-302022-01-28C16284748780-1d6a99b39-8170-a426-e053-dadaa90af4c2These 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
70934-235-30LEVOCETIRIZINE DIHYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-235LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]2Legacy NDC, 1 package rows20210101_87c4d9c1-db12-9b61-e053-2995a90abfec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN87c4d9c1-db12-9b61-e053-2995a90abfec2
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD87c4d9c1-db12-9b61-e053-2995a90abfec2
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY87c4d9c1-db12-9b61-e053-2995a90abfec2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-235-307093402353030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-235-30) 2019-01-150000-00-00NoNoCurrent