FDA.reportPublic FDA data

Zyrtec

Product NDC
63629-2798
11-digit product format
636292798
Labeler code
63629
Product ID
63629-2798_8e6594e2-8d36-4b9b-8c32-d48a5f11d9a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA019835
Marketing category
NDA
Marketing start
2008-10-01
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
63629-2798-12020-01-31C16284748780-19d75b9d0-c96d-f424-e053-dadaa90a57ceZYRTEC ®
63629-2798-22020-01-31C16284748780-19d75b9d0-c96d-f424-e053-dadaa90a57ceZYRTEC ®
63629-2798-32020-01-31C16284748780-19d75b9d0-c96d-f424-e053-dadaa90a57ceZYRTEC ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2798-1Zyrtec30 in 1 BOTTLETABLET, FILM COATED301000
63629-2798-2Zyrtec100 in 1 BOTTLETABLET, FILM COATED1001000
63629-2798-3Zyrtec15 in 1 BOTTLETABLET, FILM COATED151000

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOAZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CETIRIZINEACTIVE MOIETYYO7261ME24ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2798ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000Legacy NDC, 3 package rows20150429_02202313-75fa-43e7-b647-4b6f68780f86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN02202313-75fa-43e7-b647-4b6f68780f861000
1020026ZyrTEC 10 MG Oral TabletPSN02202313-75fa-43e7-b647-4b6f68780f861000
1020026cetirizine hydrochloride 10 MG Oral Tablet [Zyrtec]SBD02202313-75fa-43e7-b647-4b6f68780f861000
1014678cetirizine hydrochloride 10 MG Oral TabletSCD02202313-75fa-43e7-b647-4b6f68780f861000
1014678cetirizine HCl 10 MG Oral TabletSY02202313-75fa-43e7-b647-4b6f68780f861000
1020026Zyrtec (cetirizine dihydrochloride 10 MG) Oral TabletSY02202313-75fa-43e7-b647-4b6f68780f861000
1020026Zyrtec 10 MG Oral TabletSY02202313-75fa-43e7-b647-4b6f68780f861000

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63629-2798-16362927980130 in 1 BOTTLEHistorical
63629-2798-263629279802100 in 1 BOTTLEHistorical
63629-2798-36362927980315 in 1 BOTTLEHistorical