FDA.reportPublic FDA data

CETIRIZINE HYDROCHLORIDE

Product NDC
61919-538
11-digit product format
619190538
Labeler code
61919
Product ID
61919-538_f214c7ce-fa12-b6e1-e053-2a95a90a24a7
Type
HUMAN OTC DRUG
Nonproprietary name
CETIRIZINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA077829
Marketing category
ANDA
Marketing start
2019-08-14
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
No
Listing certified through
2024-12-31
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
61919-538-302020-01-31C16284748780-19d75b9d1-0372-f424-e053-dadaa90a57ceCetirizine Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-538-30Cetirizine Hydrochloride30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-538-30EA - Each61919-538529154f4-5891-478f-a8cf-f7ba469472a612015-10-02
61919-538-90EA - Each61919-538b27f5929-ce34-4be6-9198-74ba58c4181512019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]4
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]4
hypromellosesINACTIVE INGREDIENT3NXW29V3WOCETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]4
lactoseINACTIVE INGREDIENTJ2B2A4N98GCETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]4
magnesium stearateINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]4
povidoneINACTIVE INGREDIENTFZ989GH94ECETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]4
starch, cornINACTIVE INGREDIENTO8232NY3SJCETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]4
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-538CETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]4Legacy NDC, 1 package rows20151110_3a58cd65-a4ab-4aa9-a6a0-0860019642ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN3a58cd65-a4ab-4aa9-a6a0-0860019642ce4
1014678cetirizine hydrochloride 10 MG Oral TabletSCD3a58cd65-a4ab-4aa9-a6a0-0860019642ce4
1014678cetirizine HCl 10 MG Oral TabletSY3a58cd65-a4ab-4aa9-a6a0-0860019642ce4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-538-306191905383030 in 1 BOTTLEHistorical
61919-538-906191905389090 TABLET in 1 BOTTLE (61919-538-90) 90 tablet2019-08-140000-00-00NoNoCurrent