CHILDRENS CETIRIZINE HYDROCHLORIDE

Product NDC
51672-2148
11-digit product format
516722148
Labeler code
51672
Product ID
51672-2148_137524f7-318b-4772-9ce7-97593c7ad2a7
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
TARO PHARMACEUTICALS U.S.A., INC.
Application
ANDA201546
Marketing category
ANDA
Marketing start
2022-06-29
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
1 mg/mL
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
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2148-1CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE BUBBLE GUM240 mL in 1 BOTTLESOLUTION2402
51672-2148-1CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE BUBBLE GUM1 in 1 CARTONSOLUTION12
51672-2148-8CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE BUBBLE GUM1 in 1 CARTONSOLUTION12
51672-2148-8CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE BUBBLE GUM120 mL in 1 BOTTLESOLUTION1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2148CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE BUBBLE GUM (CETIRIZINE HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2Legacy NDC, 4 package rows20220825_69a63e8c-e225-4556-873e-9e5eb18c82f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN69a63e8c-e225-4556-873e-9e5eb18c82f02
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD69a63e8c-e225-4556-873e-9e5eb18c82f02
1014673cetirizine HCl 1 MG/ML Oral SyrupSY69a63e8c-e225-4556-873e-9e5eb18c82f02
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY69a63e8c-e225-4556-873e-9e5eb18c82f02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-2148-1516722148011 BOTTLE in 1 CARTON (51672-2148-1) > 240 mL in 1 BOTTLE1 bottle2022-06-290000-00-00NoNoCurrent
51672-2148-8516722148081 BOTTLE in 1 CARTON (51672-2148-8) > 120 mL in 1 BOTTLE1 bottle2022-06-290000-00-00NoNoCurrent