ALLERGY

Product NDC
41226-692
11-digit product format
412260692
Labeler code
41226
Product ID
41226-692_3e7fad54-62e1-6d0a-e063-6394a90a5785
Type
HUMAN OTC DRUG
Nonproprietary name
CETIRIZINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kroger Company
Application
ANDA078933
Marketing category
ANDA
Marketing start
2021-05-11
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
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
41226-692-14ALLERGY70 in 1 BOTTLETABLET, FILM COATED705
41226-692-14ALLERGY2 in 1 CARTONTABLET, FILM COATED25
41226-692-65ALLERGY1 in 1 CARTONTABLET, FILM COATED15
41226-692-65ALLERGY365 in 1 BOTTLETABLET, FILM COATED3655
41226-692-70ALLERGY70 in 1 BOTTLETABLET, FILM COATED705
41226-692-70ALLERGY1 in 1 CARTONTABLET, FILM COATED15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41226-692ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [KROGER COMPANY]4Current NDC, Legacy NDC, 6 package rows20240605_bc020340-ef39-e49a-e053-2a95a90af810.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNbc020340-ef39-e49a-e053-2a95a90af8105
1014678cetirizine hydrochloride 10 MG Oral TabletSCDbc020340-ef39-e49a-e053-2a95a90af8105
1014678cetirizine HCl 10 MG Oral TabletSYbc020340-ef39-e49a-e053-2a95a90af8105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41226-692-14412260692142 BOTTLE in 1 CARTON (41226-692-14) / 70 TABLET, FILM COATED in 1 BOTTLE2 bottle2021-05-110000-00-00NoNoCurrent
41226-692-65412260692651 BOTTLE in 1 CARTON (41226-692-65) / 365 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-05-110000-00-00NoNoCurrent
41226-692-70412260692701 BOTTLE in 1 CARTON (41226-692-70) / 70 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-06-03NoNoCurrent