FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
55319-939
11-digit product format
553190939
Labeler code
55319
Product ID
55319-939_65ed577d-07a6-40e5-bff5-26b9ec806f04
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
FAMILY DOLLAR SERVICES, INC
Application
ANDA077498
Marketing category
ANDA
Marketing start
2017-09-01
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-939-30Cetirizine Hydrochloride30 in 1 BOTTLETABLET303
55319-939-54Cetirizine Hydrochloride14 in 1 BLISTER PACKTABLET143

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE TABLET [FAMILY DOLLAR SERVICES, INC.]2
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE TABLET [FAMILY DOLLAR SERVICES, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCETIRIZINE HYDROCHLORIDE TABLET [FAMILY DOLLAR SERVICES, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCETIRIZINE HYDROCHLORIDE TABLET [FAMILY DOLLAR SERVICES, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE TABLET [FAMILY DOLLAR SERVICES, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACETIRIZINE HYDROCHLORIDE TABLET [FAMILY DOLLAR SERVICES, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ECETIRIZINE HYDROCHLORIDE TABLET [FAMILY DOLLAR SERVICES, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCETIRIZINE HYDROCHLORIDE TABLET [FAMILY DOLLAR SERVICES, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCETIRIZINE HYDROCHLORIDE TABLET [FAMILY DOLLAR SERVICES, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCETIRIZINE HYDROCHLORIDE TABLET [FAMILY DOLLAR SERVICES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-939CETIRIZINE HYDROCHLORIDE TABLET [FAMILY DOLLAR SERVICES, INC]3Current NDC, Legacy NDC, 2 package rows20180110_b326dacc-6123-47a7-9fde-6909db1d780b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNb326dacc-6123-47a7-9fde-6909db1d780b3
1014678cetirizine hydrochloride 10 MG Oral TabletSCDb326dacc-6123-47a7-9fde-6909db1d780b3
1014678cetirizine HCl 10 MG Oral TabletSYb326dacc-6123-47a7-9fde-6909db1d780b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-939-305531909393030 TABLET in 1 BOTTLE (55319-939-30) 30 tablet2017-09-010000-00-00NoNoCurrent
55319-939-545531909395414 TABLET in 1 BLISTER PACK (55319-939-54) 14 tablet2017-09-010000-00-00NoNoCurrent