CETIRIZINE HYDROCHLORIDE

Product NDC
73581-202
11-digit product format
735810202
Labeler code
73581
Product ID
73581-202_0e13664c-b422-d2fa-e063-6394a90a2d33
Type
HUMAN OTC DRUG
Nonproprietary name
CETIRIZINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
YYBA CORP
Application
ANDA209274
Marketing category
ANDA
Marketing start
2021-06-16
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CETIRIZINE HYDROCHLORIDE
Brand name suffix
10 MG
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014678

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73581-202-01CETIRIZINE HYDROCHLORIDE10 MG100 in 1 BOTTLETABLET1006
73581-202-05CETIRIZINE HYDROCHLORIDE10 MG500 in 1 BOTTLETABLET5006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73581-202CETIRIZINE HYDROCHLORIDE 10 MG (CETIRIZINE HYDROCHLORIDE) TABLET [YYBA CORP]6Current NDC, Legacy NDC, 2 package rows20240104_0502f197-21e1-44f2-b621-c8df1ccd956e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN0502f197-21e1-44f2-b621-c8df1ccd956e6
1014678cetirizine hydrochloride 10 MG Oral TabletSCD0502f197-21e1-44f2-b621-c8df1ccd956e6
1014678cetirizine HCl 10 MG Oral TabletSY0502f197-21e1-44f2-b621-c8df1ccd956e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73581-202-0173581020201100 TABLET in 1 BOTTLE (73581-202-01) 100 tablet2021-06-160000-00-00NoNoCurrent
73581-202-0573581020205500 TABLET in 1 BOTTLE (73581-202-05) 500 tablet2021-06-170000-00-00NoNoCurrent