FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
68151-1008
11-digit product format
681511008
Labeler code
68151
Product ID
68151-1008_6241ec88-9f31-4198-ad42-d850eb9fd932
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cetirizine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA078398
Marketing category
ANDA
Marketing start
2008-07-24
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-1008-22020-01-31C16284748780-19d75b9d0-b788-f424-e053-dadaa90a57ceCetirizine Hydrochloride Oral Solution, USP 1 mg/mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-1008-2Cetirizine Hydrochloride1 mL in 1 PACKAGESOLUTION14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cetirizine hydrochlorideACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE SYRUP [CARILION MATERIALS MANAGEMENT]2
cetirizineACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE SYRUP [CARILION MATERIALS MANAGEMENT]2
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PCETIRIZINE HYDROCHLORIDE SYRUP [CARILION MATERIALS MANAGEMENT]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCETIRIZINE HYDROCHLORIDE SYRUP [CARILION MATERIALS MANAGEMENT]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCETIRIZINE HYDROCHLORIDE SYRUP [CARILION MATERIALS MANAGEMENT]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CETIRIZINE HYDROCHLORIDE SYRUP [CARILION MATERIALS MANAGEMENT]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCETIRIZINE HYDROCHLORIDE SYRUP [CARILION MATERIALS MANAGEMENT]2
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BCETIRIZINE HYDROCHLORIDE SYRUP [CARILION MATERIALS MANAGEMENT]2
SUCROSEINACTIVE INGREDIENTC151H8M554CETIRIZINE HYDROCHLORIDE SYRUP [CARILION MATERIALS MANAGEMENT]2
WATERINACTIVE INGREDIENT059QF0KO0RCETIRIZINE HYDROCHLORIDE SYRUP [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-1008CETIRIZINE HYDROCHLORIDE SOLUTION [CARILION MATERIALS MANAGEMENT]4Legacy NDC, 1 package rows20170724_a28ff91a-34d7-4aac-ad3a-fa82e9ffeb46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNa28ff91a-34d7-4aac-ad3a-fa82e9ffeb464
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDa28ff91a-34d7-4aac-ad3a-fa82e9ffeb464
1014673cetirizine HCl 1 MG/ML Oral SyrupSYa28ff91a-34d7-4aac-ad3a-fa82e9ffeb464
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYa28ff91a-34d7-4aac-ad3a-fa82e9ffeb464

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68151-1008-2681511008021 mL in 1 PACKAGE1 mlHistorical