Cetirizine HCl

Product NDC
11673-650
11-digit product format
116730650
Labeler code
11673
Product ID
11673-650_4fe97a61-2084-5dbb-e063-6294a90a774e
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
TARGET Corporation
Application
NDA022429
Marketing category
NDA
Marketing start
2025-12-09
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cetirizine HCl
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014675

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-650-15Cetirizine HCl1 in 1 CARTONCAPSULE13
11673-650-15Cetirizine HCl40 in 1 BOTTLECAPSULE403

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSN363845a9-c379-16a7-e063-6394a90a011a3
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCD363845a9-c379-16a7-e063-6394a90a011a3
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSY363845a9-c379-16a7-e063-6394a90a011a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11673-650-15116730650151 BOTTLE in 1 CARTON (11673-650-15) / 40 CAPSULE in 1 BOTTLE1 bottle2025-12-09NoNoHistorical