Cetirizine Hydrochloride

Product NDC
63941-939
11-digit product format
639410939
Labeler code
63941
Product ID
63941-939_2d78941a-3bfd-4c92-aa00-2a4f99db44c8
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Valu Merchandisers Company
Application
ANDA077498
Marketing category
ANDA
Marketing start
2007-12-27
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
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
63941-939-30Cetirizine Hydrochloride30 in 1 BOTTLETABLET303
63941-939-54Cetirizine Hydrochloride14 in 1 BLISTER PACKTABLET143
63941-939-60Cetirizine Hydrochloride60 in 1 BOTTLETABLET603

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-939CETIRIZINE HYDROCHLORIDE TABLET [VALU MERCHANDISERS COMPANY]3Current NDC, Legacy NDC, 3 package rows20180824_4a8d2887-8ac3-4d54-9e67-4a271d416426.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN4a8d2887-8ac3-4d54-9e67-4a271d4164263
1014678cetirizine hydrochloride 10 MG Oral TabletSCD4a8d2887-8ac3-4d54-9e67-4a271d4164263
1014678cetirizine HCl 10 MG Oral TabletSY4a8d2887-8ac3-4d54-9e67-4a271d4164263

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63941-939-306394109393030 TABLET in 1 BOTTLE (63941-939-30) 30 tablet2007-12-270000-00-00NoNoCurrent
63941-939-546394109395414 TABLET in 1 BLISTER PACK (63941-939-54) 14 tablet2007-12-270000-00-00NoNoCurrent
63941-939-606394109396060 TABLET in 1 BOTTLE (63941-939-60) 60 tablet2007-12-270000-00-00NoNoCurrent