Cetirizine Hydrochloride

Product NDC
65162-146
11-digit product format
651620146
Labeler code
65162
Product ID
65162-146_36129c76-bfc7-4f3f-89bd-935bf221f9d6
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals
Application
ANDA078780
Marketing category
ANDA
Marketing start
2010-01-21
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65162-146-032020-01-31C16284748780-19d75b9d0-3f85-f424-e053-dadaa90a57ceCETIRIZINE HYDROCHLORIDE TABLETS
65162-146-502020-01-31C16284748780-19d75b9d0-3f85-f424-e053-dadaa90a57ceCETIRIZINE HYDROCHLORIDE TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-146-03Cetirizine HydrochlorideHives Relief1 in 1 CARTONTABLET15
65162-146-03Cetirizine HydrochlorideHives Relief30 in 1 BOTTLETABLET305
65162-146-50Cetirizine HydrochlorideHives Relief500 in 1 BOTTLETABLET5005

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-146CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE) TABLET [AMNEAL PHARMACEUTICALS]5Legacy NDC, 3 package rows20120222_2b839e8b-f4ac-4379-ae50-ace4008705d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN2b839e8b-f4ac-4379-ae50-ace4008705d85
1014678cetirizine hydrochloride 10 MG Oral TabletSCD2b839e8b-f4ac-4379-ae50-ace4008705d85
1014678cetirizine HCl 10 MG Oral TabletSY2b839e8b-f4ac-4379-ae50-ace4008705d85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
65162-146-03651620146031 in 1 CARTONHistorical
65162-146-5065162014650500 in 1 BOTTLEHistorical