FDA.reportPublic FDA data

cetirizine hydrochloride

Product NDC
72162-2173
11-digit product format
721622173
Labeler code
72162
Product ID
72162-2173_292230af-121b-422c-abd2-6d0de81fb94e
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078336
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
72162-2173-2cetirizine hydrochloride1 in 1 CARTONTABLET, FILM COATED1107
72162-2173-2cetirizine hydrochloride300 in 1 BOTTLETABLET, FILM COATED300107
72162-2173-3cetirizine hydrochloride1 in 1 CARTONTABLET, FILM COATED1107
72162-2173-3cetirizine hydrochloride30 in 1 BOTTLETABLET, FILM COATED30107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2173-2EA - Each72162-2173d7fd5a3d-bf81-486b-8b61-d378ef8d5b2012024-03-12
72162-2173-3EA - Each72162-21735234ce07-ba6f-475c-a466-1abc16af62aa12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2173CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, 4 package rows20250523_ae93976d-de9b-43a6-b299-ce1f1ae8d6f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNae93976d-de9b-43a6-b299-ce1f1ae8d6f8107
1014678cetirizine hydrochloride 10 MG Oral TabletSCDae93976d-de9b-43a6-b299-ce1f1ae8d6f8107
1014678cetirizine HCl 10 MG Oral TabletSYae93976d-de9b-43a6-b299-ce1f1ae8d6f8107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2173-2721622173021 BOTTLE in 1 CARTON (72162-2173-2) / 300 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-01-23NoNoHistorical
72162-2173-3721622173031 BOTTLE in 1 CARTON (72162-2173-3) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-06-18NoNoHistorical