FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
21695-709
11-digit product format
216950709
Labeler code
21695
Product ID
21695-709_d65cd557-92e1-49b0-9ff5-8479b0ed9f76
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA077946
Marketing category
ANDA
Marketing start
2007-12-27
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
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
21695-709-102019-09-24C16284748780-1934fe258-4725-48b1-e053-8cdaa90a720aCetirizine Drug Facts
21695-709-142019-09-24C16284748780-1934fe258-4725-48b1-e053-8cdaa90a720aCetirizine Drug Facts
21695-709-202019-09-24C16284748780-1934fe258-4725-48b1-e053-8cdaa90a720aCetirizine Drug Facts
21695-709-302019-09-24C16284748780-1934fe258-4725-48b1-e053-8cdaa90a720aCetirizine Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-709-10Cetirizine Hydrochloride10 in 1 BOTTLETABLET103
21695-709-14Cetirizine Hydrochloride14 in 1 BOTTLETABLET143
21695-709-20Cetirizine Hydrochloride20 in 1 BOTTLETABLET203
21695-709-30Cetirizine Hydrochloride30 in 1 BOTTLETABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-709-10EA - Each21695-7096dbbb566-f7fa-4595-a383-d46c8130094212012-07-24
21695-709-14EA - Each21695-709329ddfe2-3564-47b8-bc38-962cdde91ce512012-07-24
21695-709-20EA - Each21695-709bcc465fd-4805-4bd0-bc08-7cacfbb1ca7e12012-07-24
21695-709-30EA - Each21695-70922f9e421-f3c4-4ea9-b070-2b3dac3a5ac512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]3
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ECETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-709CETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]3Legacy NDC, 4 package rows20120420_10f3966d-9cb8-4beb-b384-6b2428e92c22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN10f3966d-9cb8-4beb-b384-6b2428e92c223
1014678cetirizine hydrochloride 10 MG Oral TabletSCD10f3966d-9cb8-4beb-b384-6b2428e92c223
1014678cetirizine HCl 10 MG Oral TabletSY10f3966d-9cb8-4beb-b384-6b2428e92c223

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-709-102169507091010 in 1 BOTTLEHistorical
21695-709-142169507091414 in 1 BOTTLEHistorical
21695-709-202169507092020 in 1 BOTTLEHistorical
21695-709-302169507093030 in 1 BOTTLEHistorical