Cetirizine Hydrochloride

Product NDC
67091-247
11-digit product format
670910247
Labeler code
67091
Product ID
67091-247_75838b78-8a5d-4f35-8be1-76d398cf1c9a
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
WinCo Foods, LLC
Application
ANDA077498
Marketing category
ANDA
Marketing start
2012-01-20
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
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67091-247-142020-01-31C16284748780-19d75b9d0-ea85-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-247-14Cetirizine Hydrochloride1 in 1 BLISTER PACKTABLET11
67091-247-14Cetirizine Hydrochloride14 in 1 CARTONTABLET141

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE TABLET [WINCO FOODS, LLC]1
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE TABLET [WINCO FOODS, LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCETIRIZINE HYDROCHLORIDE TABLET [WINCO FOODS, LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCETIRIZINE HYDROCHLORIDE TABLET [WINCO FOODS, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE TABLET [WINCO FOODS, LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACETIRIZINE HYDROCHLORIDE TABLET [WINCO FOODS, LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECETIRIZINE HYDROCHLORIDE TABLET [WINCO FOODS, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCETIRIZINE HYDROCHLORIDE TABLET [WINCO FOODS, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCETIRIZINE HYDROCHLORIDE TABLET [WINCO FOODS, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCETIRIZINE HYDROCHLORIDE TABLET [WINCO FOODS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-247CETIRIZINE HYDROCHLORIDE TABLET [WINCO FOODS, LLC]1Legacy NDC, 2 package rows20141223_75838b78-8a5d-4f35-8be1-76d398cf1c9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN75838b78-8a5d-4f35-8be1-76d398cf1c9a1
1014678cetirizine hydrochloride 10 MG Oral TabletSCD75838b78-8a5d-4f35-8be1-76d398cf1c9a1
1014678cetirizine HCl 10 MG Oral TabletSY75838b78-8a5d-4f35-8be1-76d398cf1c9a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67091-247-14670910247141 in 1 BLISTER PACKHistorical