FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
51672-4070
11-digit product format
516724070
Labeler code
51672
Product ID
51672-4070_3b528d29-2957-8382-e063-6294a90aa8a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA076601
Marketing category
ANDA
Marketing start
2014-05-01
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
51672-4070-8Cetirizine Hydrochloride120 mL in 1 BOTTLESOLUTION12014
51672-4070-8Cetirizine Hydrochloride1 in 1 CARTONSOLUTION114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4070-8ML - Milliliter51672-4070c31539f4-c130-4a4e-bf9d-dcb5df28f8de12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cetirizine HydrochlorideACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
CetirizineACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
acetic acidINACTIVE INGREDIENTQ40Q9N063PCETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXCETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9TCETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHCETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
sodium acetate anhydrousINACTIVE INGREDIENTNVG71ZZ7P0CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
sucroseINACTIVE INGREDIENTC151H8M554CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
waterINACTIVE INGREDIENT059QF0KO0RCETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4070CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]12Current NDC, Legacy NDC, 2 package rows20250116_6d81446e-f713-4ca4-af38-3d31cf618873.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN6d81446e-f713-4ca4-af38-3d31cf61887314
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD6d81446e-f713-4ca4-af38-3d31cf61887314
1014673cetirizine HCl 1 MG/ML Oral SyrupSY6d81446e-f713-4ca4-af38-3d31cf61887314
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY6d81446e-f713-4ca4-af38-3d31cf61887314
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNe626bd59-dd18-465c-b740-9d04eb48c28e6
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDe626bd59-dd18-465c-b740-9d04eb48c28e6
1014673cetirizine HCl 1 MG/ML Oral SyrupSYe626bd59-dd18-465c-b740-9d04eb48c28e6
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYe626bd59-dd18-465c-b740-9d04eb48c28e6
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN7e94be37-0971-44b3-9857-f56330d810b64
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD7e94be37-0971-44b3-9857-f56330d810b64
1014673cetirizine HCl 1 MG/ML Oral SyrupSY7e94be37-0971-44b3-9857-f56330d810b64
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY7e94be37-0971-44b3-9857-f56330d810b64
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN4ed61888-4b22-4e11-96e7-f70aa516db4f2
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD4ed61888-4b22-4e11-96e7-f70aa516db4f2
1014673cetirizine HCl 1 MG/ML Oral SyrupSY4ed61888-4b22-4e11-96e7-f70aa516db4f2
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY4ed61888-4b22-4e11-96e7-f70aa516db4f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4070-8516724070081 BOTTLE in 1 CARTON (51672-4070-8) / 120 mL in 1 BOTTLE1 bottle2014-05-010000-00-00NoNoCurrent