FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
0781-1684
11-digit product format
007811684
Labeler code
0781
Product ID
0781-1684_2ca4b053-0031-4a34-a1b1-8eaadb0879c6
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA077946
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
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
0781-1684-01Cetirizine Hydrochloride100 in 1 BOTTLETABLET1003
0781-1684-64Cetirizine Hydrochloride30 in 1 BOX, UNIT-DOSETABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-1684-01EA - Each0781-168428943ae8-5fc1-4c27-838e-4a6a41d31b3412014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]3
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]3
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCETIRIZINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCETIRIZINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]3
POLYETHYLENE GLYCOLsINACTIVE INGREDIENT3WJQ0SDW1ACETIRIZINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ECETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ECETIRIZINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCETIRIZINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCETIRIZINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE TABLET [SANDOZ INC]2
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE TABLET [SANDOZ INC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCETIRIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCETIRIZINE HYDROCHLORIDE TABLET [SANDOZ INC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCETIRIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCETIRIZINE HYDROCHLORIDE TABLET [SANDOZ INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE TABLET [SANDOZ INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACETIRIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACETIRIZINE HYDROCHLORIDE TABLET [SANDOZ INC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ECETIRIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ECETIRIZINE HYDROCHLORIDE TABLET [SANDOZ INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCETIRIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCETIRIZINE HYDROCHLORIDE TABLET [SANDOZ INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCETIRIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCETIRIZINE HYDROCHLORIDE TABLET [SANDOZ INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-1684CETIRIZINE HYDROCHLORIDE TABLET [SANDOZ INC]3Current NDC, Legacy NDC, 2 package rows20191126_760dd0e4-280a-4d95-8938-cecaa7ec75f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN10f3966d-9cb8-4beb-b384-6b2428e92c223
1014678cetirizine HCl 10 MG Oral TabletPSN760dd0e4-280a-4d95-8938-cecaa7ec75f23
1014678cetirizine HCl 10 MG Oral TabletPSNdd37b7c4-00d6-4a69-8213-713db5725e7c3
1014678cetirizine hydrochloride 10 MG Oral TabletSCD10f3966d-9cb8-4beb-b384-6b2428e92c223
1014678cetirizine hydrochloride 10 MG Oral TabletSCD760dd0e4-280a-4d95-8938-cecaa7ec75f23
1014678cetirizine hydrochloride 10 MG Oral TabletSCDdd37b7c4-00d6-4a69-8213-713db5725e7c3
1014678cetirizine HCl 10 MG Oral TabletSY10f3966d-9cb8-4beb-b384-6b2428e92c223
1014678cetirizine HCl 10 MG Oral TabletSY760dd0e4-280a-4d95-8938-cecaa7ec75f23
1014678cetirizine HCl 10 MG Oral TabletSYdd37b7c4-00d6-4a69-8213-713db5725e7c3
1014678cetirizine HCl 10 MG Oral TabletPSN8a2e62ed-3f4b-4a4f-9774-95dd4f014e6b2
1014678cetirizine hydrochloride 10 MG Oral TabletSCD8a2e62ed-3f4b-4a4f-9774-95dd4f014e6b2
1014678cetirizine HCl 10 MG Oral TabletSY8a2e62ed-3f4b-4a4f-9774-95dd4f014e6b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-1684-0100781168401100 TABLET in 1 BOTTLE (0781-1684-01) 100 tablet2007-12-270000-00-00NoNoCurrent
0781-1684-640078116846430 TABLET in 1 BOX, UNIT-DOSE (0781-1684-64) 30 tablet2007-12-270000-00-00NoNoCurrent