Levocetirizine Dihydrochloride

Product NDC
50090-3698
11-digit product format
500903698
Labeler code
50090
Product ID
50090-3698_03d3e55c-34fb-4b19-b343-c7361ae12745
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocetirizine Dihydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090199
Marketing category
ANDA
Marketing start
2011-09-06
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
2022-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3698-0Levocetirizine Dihydrochloride30 in 1 BOTTLETABLET, FILM COATED308
50090-3698-1Levocetirizine Dihydrochloride90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3698LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]8Legacy NDC, 2 package rows20210417_ae073592-c187-4a6d-ae48-ffae2502b9eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSNae073592-c187-4a6d-ae48-ffae2502b9eb8
855172levocetirizine dihydrochloride 5 MG Oral TabletSCDae073592-c187-4a6d-ae48-ffae2502b9eb8
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSYae073592-c187-4a6d-ae48-ffae2502b9eb8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3698-05009036980030 TABLET, FILM COATED in 1 BOTTLE (50090-3698-0) 2018-10-190000-00-00NoNoCurrent
50090-3698-15009036980190 TABLET, FILM COATED in 1 BOTTLE (50090-3698-1) 2018-10-190000-00-00NoNoCurrent