FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
55111-351
11-digit product format
551110351
Labeler code
55111
Product ID
55111-351_000d3a47-3836-b678-9487-2bbc518cd57f
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr.Reddy's Laboratories Limited
Application
ANDA078343
Marketing category
ANDA
Marketing start
2008-01-15
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014678

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]5
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]5
POVIDONEINACTIVE INGREDIENTFZ989GH94ECETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-351CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]8Current NDC, Legacy NDC20250321_de152651-bfcd-856a-8329-a2ac93a376bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNde152651-bfcd-856a-8329-a2ac93a376bc8
1014678cetirizine hydrochloride 10 MG Oral TabletSCDde152651-bfcd-856a-8329-a2ac93a376bc8
1014678cetirizine HCl 10 MG Oral TabletSYde152651-bfcd-856a-8329-a2ac93a376bc8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-351-04551110351041 BOTTLE in 1 CARTON (55111-351-04) / 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2008-01-150000-00-00NoNoCurrent
55111-351-30551110351301 BOTTLE in 1 CARTON (55111-351-30) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2008-01-150000-00-00NoNoCurrent
55111-351-45551110351451 BOTTLE in 1 CARTON (55111-351-45) / 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2008-01-150000-00-00NoNoCurrent
55111-351-47551110351472 BOTTLE in 1 CARTON (55111-351-47) / 175 TABLET, FILM COATED in 1 BOTTLE2 bottle2008-01-150000-00-00NoNoCurrent
55111-351-51551110351511 BOTTLE in 1 CARTON (55111-351-51) / 75 TABLET, FILM COATED in 1 BOTTLE1 bottle2008-01-150000-00-00NoNoCurrent
55111-351-60551110351601 BOTTLE in 1 CARTON (55111-351-60) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2008-01-150000-00-00NoNoCurrent
55111-351-74551110351742 BLISTER PACK in 1 CARTON (55111-351-74) / 7 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2008-01-150000-00-00NoNoCurrent
55111-351-90551110351901 BOTTLE in 1 CARTON (55111-351-90) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2008-01-150000-00-00NoNoCurrent