Cetirizine Hydrochloride

Product NDC
67296-1085
11-digit product format
672961085
Labeler code
67296
Product ID
67296-1085_d60fd320-eb36-4489-e053-2995a90a8432
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug
Application
ANDA077829
Marketing category
ANDA
Marketing start
2020-09-21
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
2023-12-31
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
67296-1085-32024-01-30C16284748780-11030e365-1688-111a-e063-dadaa90a10e2Cetirizine 10 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1085-3Cetirizine Hydrochloride30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1085CETIRIZINE HYDROCHLORIDE TABLET [REDPHARM DRUG]3Legacy NDC, 1 package rows20220121_afd7b4c9-9ef0-52e8-e053-2a95a90a6b33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNafd7b4c9-9ef0-52e8-e053-2a95a90a6b333
1014678cetirizine hydrochloride 10 MG Oral TabletSCDafd7b4c9-9ef0-52e8-e053-2a95a90a6b333
1014678cetirizine HCl 10 MG Oral TabletSYafd7b4c9-9ef0-52e8-e053-2a95a90a6b333

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1085-36729610850330 TABLET in 1 BOTTLE (67296-1085-3) 30 tablet2020-09-210000-00-00NoNoCurrent