CETIRIZINE HYDROCHLORIDE

Product NDC
61919-429
11-digit product format
619190429
Labeler code
61919
Product ID
61919-429_f213f0a8-4096-18e3-e053-2995a90a19f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CETIRIZINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA077829
Marketing category
ANDA
Marketing start
2016-12-22
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2024-12-31
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
61919-429-302025-01-30C16284748780-12cef2736-9c50-d83d-e063-dadaa90ab31fCETIRIZINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-429-30CETIRIZINE HYDROCHLORIDE30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-429CETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]3Legacy NDC, 1 package rows20230113_4445548f-d11c-3c1b-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN4445548f-d11c-3c1b-e054-00144ff8d46c3
1014678cetirizine hydrochloride 10 MG Oral TabletSCD4445548f-d11c-3c1b-e054-00144ff8d46c3
1014678cetirizine HCl 10 MG Oral TabletSY4445548f-d11c-3c1b-e054-00144ff8d46c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-429-306191904293030 TABLET in 1 BOTTLE (61919-429-30) 30 tablet2016-12-220000-00-00NoNoCurrent