FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
63629-4914
11-digit product format
636294914
Labeler code
63629
Product ID
63629-4914_3db925ae-d07d-4da4-9dab-155db44d75a0
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077829
Marketing category
ANDA
Marketing start
2009-10-01
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
5 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
Cetirizine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014676

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
63629-4914-12024-05-24C16284748780-19855d018-d892-cd31-e053-dbdaa90ab51aCetirizine Hydrochloride Tablets USP 5 mg, Allergy
63629-4914-12024-01-30C16284748780-19855d018-d892-cd31-e053-dbdaa90ab51aCetirizine Hydrochloride Tablets USP 5 mg, Allergy
63629-4914-12022-02-16C16284748780-19855d018-d892-cd31-e053-dbdaa90ab51aCetirizine Hydrochloride Tablets USP 5 mg, Allergy
63629-4914-12019-11-27C16284748780-19855d018-d892-cd31-e053-dbdaa90ab51aCetirizine Hydrochloride Tablets USP 5 mg, Allergy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-4914-1Cetirizine Hydrochloride30 in 1 BOTTLETABLET301003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCETIRIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GCETIRIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACETIRIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
POVIDONESINACTIVE INGREDIENTFZ989GH94ECETIRIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCETIRIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCETIRIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4914CETIRIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1003Current NDC, Legacy NDC, 1 package rows20240524_ddec7d64-ab3d-4ddd-9bcd-b7f4d2b46be7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014676cetirizine HCl 5 MG Oral TabletPSNddec7d64-ab3d-4ddd-9bcd-b7f4d2b46be71003
1014676cetirizine hydrochloride 5 MG Oral TabletSCDddec7d64-ab3d-4ddd-9bcd-b7f4d2b46be71003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-4914-16362949140130 TABLET in 1 BOTTLE (63629-4914-1) 30 tablet2013-02-190000-00-00NoNoCurrent