FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
45802-626
11-digit product format
458020626
Labeler code
45802
Product ID
45802-626_2263eac3-aa51-4b35-8535-db7e21cf5660
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cetirizine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA078398
Marketing category
ANDA
Marketing start
2008-07-24
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
1 mg/mL
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 HYDROCHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014673

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-626-26Cetirizine Hydrochloride120 mL in 1 BOTTLESOLUTION1209
45802-626-26Cetirizine Hydrochloride1 in 1 CARTONSOLUTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-626-26ML - Milliliter45802-62665749fab-769d-4d55-88b5-08901c521dd812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cetirizine hydrochlorideACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE SYRUP [PERRIGO NEW YORK INC]3
cetirizineACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE SYRUP [PERRIGO NEW YORK INC]3
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PCETIRIZINE HYDROCHLORIDE SYRUP [PERRIGO NEW YORK INC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCETIRIZINE HYDROCHLORIDE SYRUP [PERRIGO NEW YORK INC]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCETIRIZINE HYDROCHLORIDE SYRUP [PERRIGO NEW YORK INC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CETIRIZINE HYDROCHLORIDE SYRUP [PERRIGO NEW YORK INC]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCETIRIZINE HYDROCHLORIDE SYRUP [PERRIGO NEW YORK INC]3
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BCETIRIZINE HYDROCHLORIDE SYRUP [PERRIGO NEW YORK INC]3
SUCROSEINACTIVE INGREDIENTC151H8M554CETIRIZINE HYDROCHLORIDE SYRUP [PERRIGO NEW YORK INC]3
WATERINACTIVE INGREDIENT059QF0KO0RCETIRIZINE HYDROCHLORIDE SYRUP [PERRIGO NEW YORK INC]3
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
45802-626CETIRIZINE HYDROCHLORIDE SOLUTION [PADAGIS ISRAEL PHARMACEUTICALS LTD]8Current NDC, Legacy NDC, 2 package rows20230808_2f47dbc5-dfb4-425c-9fe4-777fa3c4e72e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN2f47dbc5-dfb4-425c-9fe4-777fa3c4e72e9
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD2f47dbc5-dfb4-425c-9fe4-777fa3c4e72e9
1014673cetirizine HCl 1 MG/ML Oral SyrupSY2f47dbc5-dfb4-425c-9fe4-777fa3c4e72e9
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY2f47dbc5-dfb4-425c-9fe4-777fa3c4e72e9
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNa28ff91a-34d7-4aac-ad3a-fa82e9ffeb464
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNe874264a-becc-45d0-b934-779eab5f50854
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDa28ff91a-34d7-4aac-ad3a-fa82e9ffeb464
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDe874264a-becc-45d0-b934-779eab5f50854
1014673cetirizine HCl 1 MG/ML Oral SyrupSYa28ff91a-34d7-4aac-ad3a-fa82e9ffeb464
1014673cetirizine HCl 1 MG/ML Oral SyrupSYe874264a-becc-45d0-b934-779eab5f50854
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYa28ff91a-34d7-4aac-ad3a-fa82e9ffeb464
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYe874264a-becc-45d0-b934-779eab5f50854

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-626-26458020626261 BOTTLE in 1 CARTON (45802-626-26) / 120 mL in 1 BOTTLE1 bottle2008-07-240000-00-00NoNoCurrent