FDA.reportPublic FDA data

cetirizine hydrochloride

Product NDC
45802-974
11-digit product format
458020974
Labeler code
45802
Product ID
45802-974_71411b7e-4fb8-4c33-b260-287128711d0a
Type
HUMAN OTC DRUG
Nonproprietary name
cetirizine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA090254
Marketing category
ANDA
Marketing start
2008-04-15
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
5 mg/5mL
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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014673

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-974-26cetirizine hydrochloride1 in 1 CARTONSOLUTION15
45802-974-26cetirizine hydrochloride118 mL in 1 BOTTLESOLUTION1185

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-974-26ML - Milliliter45802-974d68604aa-8f6d-4382-b79c-5482855799c412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE LIQUID [PERRIGO NEW YORK INC]1
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE LIQUID [PERRIGO NEW YORK INC]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PCETIRIZINE HYDROCHLORIDE LIQUID [PERRIGO NEW YORK INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCETIRIZINE HYDROCHLORIDE LIQUID [PERRIGO NEW YORK INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCETIRIZINE HYDROCHLORIDE LIQUID [PERRIGO NEW YORK INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CETIRIZINE HYDROCHLORIDE LIQUID [PERRIGO NEW YORK INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCETIRIZINE HYDROCHLORIDE LIQUID [PERRIGO NEW YORK INC]1
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BCETIRIZINE HYDROCHLORIDE LIQUID [PERRIGO NEW YORK INC]1
SUCROSEINACTIVE INGREDIENTC151H8M554CETIRIZINE HYDROCHLORIDE LIQUID [PERRIGO NEW YORK INC]1
WATERINACTIVE INGREDIENT059QF0KO0RCETIRIZINE HYDROCHLORIDE LIQUID [PERRIGO NEW YORK INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-974CETIRIZINE HYDROCHLORIDE SOLUTION [PADAGIS ISRAEL PHARMACEUTICALS LTD]5Current NDC, Legacy NDC, 2 package rows20250122_c2cf555d-986c-4e89-ac4f-938e92c418e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNc2cf555d-986c-4e89-ac4f-938e92c418e25
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDc2cf555d-986c-4e89-ac4f-938e92c418e25
1014673cetirizine HCl 1 MG/ML Oral SyrupSYc2cf555d-986c-4e89-ac4f-938e92c418e25
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYc2cf555d-986c-4e89-ac4f-938e92c418e25
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN0dc5a72f-1cc4-4cfc-a969-0ed781f7aa6f2
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD0dc5a72f-1cc4-4cfc-a969-0ed781f7aa6f2
1014673cetirizine HCl 1 MG/ML Oral SyrupSY0dc5a72f-1cc4-4cfc-a969-0ed781f7aa6f2
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY0dc5a72f-1cc4-4cfc-a969-0ed781f7aa6f2
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN2b348ce4-7c6e-488f-a781-17b26a1707621
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD2b348ce4-7c6e-488f-a781-17b26a1707621
1014673cetirizine HCl 1 MG/ML Oral SyrupSY2b348ce4-7c6e-488f-a781-17b26a1707621
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY2b348ce4-7c6e-488f-a781-17b26a1707621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-974-26458020974261 BOTTLE in 1 CARTON (45802-974-26) / 118 mL in 1 BOTTLE1 bottle2008-04-150000-00-00NoNoCurrent