Cetirizine Hydrochloride

Product NDC
68998-939
11-digit product format
689980939
Labeler code
68998
Product ID
68998-939_1e5b54b1-a7d9-44ae-b2e5-0a77793ad13a
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Marc Glassman, Inc.
Application
ANDA077498
Marketing category
ANDA
Marketing start
2012-11-01
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
68998-939-30Cetirizine Hydrochloride30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68998-939CETIRIZINE HYDROCHLORIDE TABLET [MARC GLASSMAN, INC.]1Current NDC, Legacy NDC, 1 package rows20180622_f30900e6-425f-43e0-81b6-1fa3bd321f0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNf30900e6-425f-43e0-81b6-1fa3bd321f0b1
1014678cetirizine hydrochloride 10 MG Oral TabletSCDf30900e6-425f-43e0-81b6-1fa3bd321f0b1
1014678cetirizine HCl 10 MG Oral TabletSYf30900e6-425f-43e0-81b6-1fa3bd321f0b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68998-939-306899809393030 TABLET in 1 BOTTLE (68998-939-30) 30 tablet2012-11-010000-00-00NoNoCurrent