Cetirizine Hydrochloride

Product NDC
50090-5518
11-digit product format
500905518
Labeler code
50090
Product ID
50090-5518_f5d388ce-ea24-4c30-b5f6-74719f1113f9
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
2022-12-31
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
50090-5518-12023-01-30C16284748780-1f386c64a-2f88-0266-e053-dadaa90a7c1aCetirizine Hydrochloride
50090-5518-32023-01-30C16284748780-1f386c64a-2f88-0266-e053-dadaa90a7c1aCetirizine Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5518-1Cetirizine Hydrochloride90 in 1 BOTTLETABLET903
50090-5518-3Cetirizine Hydrochloride90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5518CETIRIZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20210615_9ff21853-ff3d-4b0e-a4a6-342d0ef459ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN9ff21853-ff3d-4b0e-a4a6-342d0ef459ae3
1014678cetirizine hydrochloride 10 MG Oral TabletSCD9ff21853-ff3d-4b0e-a4a6-342d0ef459ae3
1014678cetirizine HCl 10 MG Oral TabletSY9ff21853-ff3d-4b0e-a4a6-342d0ef459ae3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5518-15009055180190 TABLET in 1 BOTTLE (50090-5518-1) 90 tablet2021-04-140000-00-00NoNoCurrent
50090-5518-35009055180390 TABLET in 1 BOTTLE (50090-5518-3) 90 tablet2021-04-140000-00-00NoNoCurrent