FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
59779-939
11-digit product format
597790939
Labeler code
59779
Product ID
59779-939_a4eac37b-e135-4bd8-aa49-998f87caec64
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA077498
Marketing category
ANDA
Marketing start
2007-12-27
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
59779-939-132020-01-31C16284748780-19d75b9d0-b464-f424-e053-dadaa90a57ceDrug Facts
59779-939-302020-01-31C16284748780-19d75b9d0-b464-f424-e053-dadaa90a57ceDrug Facts
59779-939-432020-01-31C16284748780-19d75b9d0-b464-f424-e053-dadaa90a57ceDrug Facts
59779-939-542020-01-31C16284748780-19d75b9d0-b464-f424-e053-dadaa90a57ceDrug Facts
59779-939-562020-01-31C16284748780-19d75b9d0-b464-f424-e053-dadaa90a57ceDrug Facts
59779-939-902020-01-31C16284748780-19d75b9d0-b464-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-939-13Cetirizine Hydrochloride120 in 1 BOTTLETABLET1201
59779-939-30Cetirizine Hydrochloride30 in 1 BOTTLETABLET301
59779-939-43Cetirizine Hydrochloride45 in 1 BOTTLETABLET451
59779-939-54Cetirizine Hydrochloride14 in 1 BLISTER PACKTABLET141
59779-939-56Cetirizine Hydrochloride5 in 1 BLISTER PACKTABLET51
59779-939-90Cetirizine Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-939CETIRIZINE HYDROCHLORIDE TABLET [CVS PHARMACY]1Legacy NDC, 6 package rows20130304_d43cf3db-f414-4697-9cd3-482066019c99.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNd43cf3db-f414-4697-9cd3-482066019c991
1014678cetirizine hydrochloride 10 MG Oral TabletSCDd43cf3db-f414-4697-9cd3-482066019c991
1014678cetirizine HCl 10 MG Oral TabletSYd43cf3db-f414-4697-9cd3-482066019c991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
59779-939-1359779093913120 in 1 BOTTLEHistorical
59779-939-305977909393030 in 1 BOTTLEHistorical
59779-939-435977909394345 in 1 BOTTLEHistorical
59779-939-545977909395414 in 1 BLISTER PACKHistorical
59779-939-56597790939565 in 1 BLISTER PACKHistorical
59779-939-905977909399090 in 1 BOTTLEHistorical