Cetirizine Hydrochloride (Allergy)

Product NDC
30142-172
11-digit product format
301420172
Labeler code
30142
Product ID
30142-172_38264bca-705b-4ca5-8387-ad60736a2eb8
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
KROGER COMPANY
Application
ANDA090760
Marketing category
ANDA
Marketing start
2021-03-15
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 (Allergy)
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
30142-172-09Cetirizine Hydrochloride (Allergy)30 in 1 BOTTLETABLET303
30142-172-09Cetirizine Hydrochloride (Allergy)1 in 1 CARTONTABLET13
30142-172-54Cetirizine Hydrochloride (Allergy)1 in 1 CARTONTABLET13
30142-172-54Cetirizine Hydrochloride (Allergy)70 in 1 BOTTLETABLET703

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-172CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [KROGER COMPANY]3Current NDC, Legacy NDC, 4 package rows20210416_b92d959d-dd35-b2a3-e053-2995a90af3ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNb92d959d-dd35-b2a3-e053-2995a90af3ff3
1014678cetirizine hydrochloride 10 MG Oral TabletSCDb92d959d-dd35-b2a3-e053-2995a90af3ff3
1014678cetirizine HCl 10 MG Oral TabletSYb92d959d-dd35-b2a3-e053-2995a90af3ff3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-172-09301420172091 BOTTLE in 1 CARTON (30142-172-09) / 30 TABLET in 1 BOTTLE1 bottle2021-03-150000-00-00NoNoCurrent
30142-172-54301420172541 BOTTLE in 1 CARTON (30142-172-54) / 70 TABLET in 1 BOTTLE1 bottle2021-03-150000-00-00NoNoCurrent