FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
68016-353
11-digit product format
680160353
Labeler code
68016
Product ID
68016-353_eb7fc54d-0dd6-4851-b9ab-23709ce16754
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Chain Drug Consortium, LLC
Application
ANDA090142
Marketing category
ANDA
Marketing start
2013-09-10
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-353-302020-01-31C16284748780-19d75b9d1-0db6-f424-e053-dadaa90a57ceCetirizine Hydrochloride Chewable Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-353-30Cetirizine Hydrochloride30 in 1 BOTTLETABLET, CHEWABLE302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM, LLC ]2
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM, LLC ]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM, LLC ]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM, LLC ]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM, LLC ]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM, LLC ]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM, LLC ]2
GUAR GUMINACTIVE INGREDIENTE89I1637KECETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM, LLC ]2
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GCETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM, LLC ]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM, LLC ]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ACETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM, LLC ]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM, LLC ]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM, LLC ]2
SUCROSEINACTIVE INGREDIENTC151H8M554CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM, LLC ]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM, LLC ]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-353CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM, LLC ]2Legacy NDC, 1 package rows20130910_dcc69bbe-e24c-4acf-8746-559ac1600dda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014674cetirizine HCl 10 MG Chewable TabletPSNdcc69bbe-e24c-4acf-8746-559ac1600dda2
1014674cetirizine hydrochloride 10 MG Chewable TabletSCDdcc69bbe-e24c-4acf-8746-559ac1600dda2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68016-353-306801603533030 in 1 BOTTLEHistorical