FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
0378-3637
11-digit product format
003783637
Labeler code
0378
Product ID
0378-3637_5670c6c3-a4ab-4268-917a-99e0579f3079
Type
HUMAN OTC DRUG
Nonproprietary name
cetirizine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA076677
Marketing category
ANDA
Marketing start
2007-12-27
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
Rxcui1014676, 1014678

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
0378-3637-01Cetirizine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10010
0378-3637-05Cetirizine Hydrochloride500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-3637-01EA - Each0378-3637028bf28b-129a-44b3-b17f-3ec0cc8c05e512012-07-24
0378-3637-05EA - Each0378-36377b3d41e9-08e1-49ee-9c56-710b4d94508412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IECETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IECETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
TRIACETININACTIVE INGREDIENTXHX3C3X673CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
TRIACETININACTIVE INGREDIENTXHX3C3X673CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE TABLET [APOTHECA INC.]2
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE TABLET [APOTHECA INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCETIRIZINE HYDROCHLORIDE TABLET [APOTHECA INC.]2
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOCETIRIZINE HYDROCHLORIDE TABLET [APOTHECA INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE TABLET [APOTHECA INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCETIRIZINE HYDROCHLORIDE TABLET [APOTHECA INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-3637CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 2 package rows20220113_487ae0f0-320c-4534-b9e2-0e215f167cea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNbd0dc7f6-5fb9-4381-bd81-b150b75a2c6812
1014678cetirizine hydrochloride 10 MG Oral TabletSCDbd0dc7f6-5fb9-4381-bd81-b150b75a2c6812
1014678cetirizine HCl 10 MG Oral TabletSYbd0dc7f6-5fb9-4381-bd81-b150b75a2c6812
1014678cetirizine HCl 10 MG Oral TabletPSN487ae0f0-320c-4534-b9e2-0e215f167cea10
1014676cetirizine HCl 5 MG Oral TabletPSN487ae0f0-320c-4534-b9e2-0e215f167cea10
1014678cetirizine hydrochloride 10 MG Oral TabletSCD487ae0f0-320c-4534-b9e2-0e215f167cea10
1014676cetirizine hydrochloride 5 MG Oral TabletSCD487ae0f0-320c-4534-b9e2-0e215f167cea10
1014678cetirizine HCl 10 MG Oral TabletSY487ae0f0-320c-4534-b9e2-0e215f167cea10
1014678cetirizine HCl 10 MG Oral TabletPSN734118ec-bf9a-4e58-b728-50b6c832b2702
1014678cetirizine HCl 10 MG Oral TabletPSNabaf61ad-17bd-4dcf-aff1-6687c4cb1b9f2
1014678cetirizine hydrochloride 10 MG Oral TabletSCD734118ec-bf9a-4e58-b728-50b6c832b2702
1014678cetirizine hydrochloride 10 MG Oral TabletSCDabaf61ad-17bd-4dcf-aff1-6687c4cb1b9f2
1014678cetirizine HCl 10 MG Oral TabletSY734118ec-bf9a-4e58-b728-50b6c832b2702
1014678cetirizine HCl 10 MG Oral TabletSYabaf61ad-17bd-4dcf-aff1-6687c4cb1b9f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-3637-0100378363701100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3637-01) 2007-12-270000-00-00NoNoCurrent
0378-3637-0500378363705500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3637-05) 2007-12-270000-00-00NoNoCurrent