Cetirizine HCl

Product NDC
46122-613
11-digit product format
461220613
Labeler code
46122
Product ID
46122-613_df610219-ee3e-1e7e-e053-2995a90a94a3
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
AMERISOURCE BERGEN
Application
NDA022429
Marketing category
NDA
Marketing start
2019-06-18
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 HCl
Listing expiration
2026-12-31

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
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-613-63Cetirizine HCl1 in 1 CARTONCAPSULE12
46122-613-63Cetirizine HCl25 in 1 BOTTLE, PLASTICCAPSULE252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-613CETIRIZINE HCL CAPSULE [AMERISOURCE BERGEN]2Current NDC, Legacy NDC, 2 package rows20220520_75f2649d-005e-4f16-a7c3-ae966f3a7a00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSN75f2649d-005e-4f16-a7c3-ae966f3a7a002
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCD75f2649d-005e-4f16-a7c3-ae966f3a7a002
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSY75f2649d-005e-4f16-a7c3-ae966f3a7a002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46122-613-63461220613631 BOTTLE, PLASTIC in 1 CARTON (46122-613-63) / 25 CAPSULE in 1 BOTTLE, PLASTIC2019-06-180000-00-00NoNoCurrent