FDA.reportPublic FDA data

CETIRIZINE HYDROCHLORIDE

Product NDC
52959-923
11-digit product format
529590923
Labeler code
52959
Product ID
52959-923_5f4e05af-61a5-7f84-e053-2a91aa0ac6f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CETIRIZINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
H. J. Harkins Company Inc.
Application
ANDA077946
Marketing category
ANDA
Marketing start
2017-01-03
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
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
52959-923-072020-01-31C16284748780-19d75b9d0-9aff-f424-e053-dadaa90a57ce5f4e05af-61a4-7f84-e053-2a91aa0ac6f6
52959-923-102020-01-31C16284748780-19d75b9d0-9aff-f424-e053-dadaa90a57ce5f4e05af-61a4-7f84-e053-2a91aa0ac6f6
52959-923-142020-01-31C16284748780-19d75b9d0-9aff-f424-e053-dadaa90a57ce5f4e05af-61a4-7f84-e053-2a91aa0ac6f6
52959-923-152020-01-31C16284748780-19d75b9d0-9aff-f424-e053-dadaa90a57ce5f4e05af-61a4-7f84-e053-2a91aa0ac6f6
52959-923-202020-01-31C16284748780-19d75b9d0-9aff-f424-e053-dadaa90a57ce5f4e05af-61a4-7f84-e053-2a91aa0ac6f6
52959-923-302020-01-31C16284748780-19d75b9d0-9aff-f424-e053-dadaa90a57ce5f4e05af-61a4-7f84-e053-2a91aa0ac6f6
52959-923-602020-01-31C16284748780-19d75b9d0-9aff-f424-e053-dadaa90a57ce5f4e05af-61a4-7f84-e053-2a91aa0ac6f6
52959-923-902020-01-31C16284748780-19d75b9d0-9aff-f424-e053-dadaa90a57ce5f4e05af-61a4-7f84-e053-2a91aa0ac6f6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-923-07CETIRIZINE HYDROCHLORIDE7 in 1 CONTAINERTABLET71
52959-923-10CETIRIZINE HYDROCHLORIDE10 in 1 CONTAINERTABLET101
52959-923-14CETIRIZINE HYDROCHLORIDE14 in 1 CONTAINERTABLET141
52959-923-15CETIRIZINE HYDROCHLORIDE15 in 1 CONTAINERTABLET151
52959-923-20CETIRIZINE HYDROCHLORIDE20 in 1 CONTAINERTABLET201
52959-923-30CETIRIZINE HYDROCHLORIDE30 in 1 CONTAINERTABLET301
52959-923-60CETIRIZINE HYDROCHLORIDE60 in 1 CONTAINERTABLET601
52959-923-90CETIRIZINE HYDROCHLORIDE90 in 1 CONTAINERTABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-923CETIRIZINE HYDROCHLORIDE TABLET [H. J. HARKINS COMPANY INC.]1Legacy NDC, 8 package rows20171202_5f4e05af-61a4-7f84-e053-2a91aa0ac6f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN5f4e05af-61a4-7f84-e053-2a91aa0ac6f61
1014678cetirizine hydrochloride 10 MG Oral TabletSCD5f4e05af-61a4-7f84-e053-2a91aa0ac6f61
1014678cetirizine HCl 10 MG Oral TabletSY5f4e05af-61a4-7f84-e053-2a91aa0ac6f61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-923-07529590923077 in 1 CONTAINERHistorical
52959-923-105295909231010 in 1 CONTAINERHistorical
52959-923-145295909231414 in 1 CONTAINERHistorical
52959-923-155295909231515 in 1 CONTAINERHistorical
52959-923-205295909232020 in 1 CONTAINERHistorical
52959-923-305295909233030 in 1 CONTAINERHistorical
52959-923-605295909236060 in 1 CONTAINERHistorical
52959-923-905295909239090 in 1 CONTAINERHistorical