Cetirizine Hydrochloride

Product NDC
36800-244
11-digit product format
368000244
Labeler code
36800
Product ID
36800-244_9b26e69e-dccf-4dce-960a-61a127a951ad
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA077498
Marketing category
ANDA
Marketing start
2007-12-27
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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
36800-244-182020-01-31C16284748780-19d75b9d0-bfec-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-244-18Cetirizine Hydrochloride5 in 1 BLISTER PACKTABLET51

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-244CETIRIZINE HYDROCHLORIDE TABLET [TOPCO ASSOCIATES LLC]1Legacy NDC, 1 package rows20130110_d4e6559d-882a-46dd-a735-f5bb5cd22885.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNd4e6559d-882a-46dd-a735-f5bb5cd228851
1014678cetirizine hydrochloride 10 MG Oral TabletSCDd4e6559d-882a-46dd-a735-f5bb5cd228851
1014678cetirizine HCl 10 MG Oral TabletSYd4e6559d-882a-46dd-a735-f5bb5cd228851

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
36800-244-18368000244185 in 1 BLISTER PACKHistorical