FDA.reportPublic FDA data

Cetirizine Hydrochloride (Allergy)

Product NDC
58602-445
11-digit product format
586020445
Labeler code
58602
Product ID
58602-445_146cd9eb-d2c1-4424-9e37-350004f18507
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA090760
Marketing category
ANDA
Marketing start
2015-08-05
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 (Allergy)
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
58602-445-01Cetirizine Hydrochloride (Allergy)14 in 1 BLISTER PACKTABLET1411
58602-445-01Cetirizine Hydrochloride (Allergy)1 in 1 CARTONTABLET111
58602-445-09Cetirizine Hydrochloride (Allergy)1 in 1 CARTONTABLET111
58602-445-09Cetirizine Hydrochloride (Allergy)30 in 1 BOTTLETABLET3011
58602-445-15Cetirizine Hydrochloride (Allergy)1 in 1 CARTONTABLET111
58602-445-15Cetirizine Hydrochloride (Allergy)60 in 1 BOTTLETABLET6011
58602-445-17Cetirizine Hydrochloride (Allergy)1 in 1 CARTONTABLET111
58602-445-17Cetirizine Hydrochloride (Allergy)45 in 1 BOTTLETABLET4511
58602-445-19Cetirizine Hydrochloride (Allergy)1 in 1 CARTONTABLET111
58602-445-19Cetirizine Hydrochloride (Allergy)90 in 1 BOTTLETABLET9011
58602-445-21Cetirizine Hydrochloride (Allergy)10 in 1 BLISTER PACKTABLET1011
58602-445-21Cetirizine Hydrochloride (Allergy)10 in 1 CARTONTABLET1011
58602-445-38Cetirizine Hydrochloride (Allergy)1 in 1 CARTONTABLET111
58602-445-38Cetirizine Hydrochloride (Allergy)300 in 1 BOTTLETABLET30011
58602-445-40Cetirizine Hydrochloride (Allergy)500 in 1 BOTTLETABLET50011
58602-445-41Cetirizine Hydrochloride (Allergy)1000 in 1 BOTTLETABLET100011
58602-445-47Cetirizine Hydrochloride (Allergy)75 in 1 PACKAGE, COMBINATIONTABLET7511
58602-445-54Cetirizine Hydrochloride (Allergy)1 in 1 CARTONTABLET111
58602-445-54Cetirizine Hydrochloride (Allergy)70 in 1 BOTTLETABLET7011
58602-445-60Cetirizine Hydrochloride (Allergy)1 in 1 CARTONTABLET111
58602-445-60Cetirizine Hydrochloride (Allergy)5 in 1 BLISTER PACKTABLET511
58602-445-65Cetirizine Hydrochloride (Allergy)2 in 1 CARTONTABLET211
58602-445-65Cetirizine Hydrochloride (Allergy)7 in 1 BLISTER PACKTABLET711
58602-445-94Cetirizine Hydrochloride (Allergy)100 in 1 BOTTLETABLET10011
58602-445-94Cetirizine Hydrochloride (Allergy)1 in 1 CARTONTABLET111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58602-445-09EA - Each58602-445eb8537b0-77ad-44b0-9d7f-b1a2af8c51db12020-02-13
58602-445-40EA - Each58602-44574cf527a-e023-424f-8699-e5a6f5a7795012022-08-04
58602-445-94EA - Each58602-445938c84cc-f01e-403e-a5d2-8e4fd5da694e12020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC]1
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-445CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC]11Current NDC, Legacy NDC, 25 package rows20240915_3cf969e6-6bc9-4dae-ab6a-b24c0fc46b25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN3cf969e6-6bc9-4dae-ab6a-b24c0fc46b2511
1014676cetirizine HCl 5 MG Oral TabletPSN3cf969e6-6bc9-4dae-ab6a-b24c0fc46b2511
1014678cetirizine hydrochloride 10 MG Oral TabletSCD3cf969e6-6bc9-4dae-ab6a-b24c0fc46b2511
1014676cetirizine hydrochloride 5 MG Oral TabletSCD3cf969e6-6bc9-4dae-ab6a-b24c0fc46b2511
1014678cetirizine HCl 10 MG Oral TabletSY3cf969e6-6bc9-4dae-ab6a-b24c0fc46b2511
1014678cetirizine HCl 10 MG Oral TabletPSN73122009-531b-4929-bf57-494a6fc65b734
1014678cetirizine HCl 10 MG Oral TabletPSNd69083c4-b028-453c-8235-560b40ad358b4
1014678cetirizine hydrochloride 10 MG Oral TabletSCD73122009-531b-4929-bf57-494a6fc65b734
1014678cetirizine hydrochloride 10 MG Oral TabletSCDd69083c4-b028-453c-8235-560b40ad358b4
1014678cetirizine HCl 10 MG Oral TabletSY73122009-531b-4929-bf57-494a6fc65b734
1014678cetirizine HCl 10 MG Oral TabletSYd69083c4-b028-453c-8235-560b40ad358b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-445-01586020445011 BLISTER PACK in 1 CARTON (58602-445-01) / 14 TABLET in 1 BLISTER PACK1 blister pack2015-08-050000-00-00NoNoCurrent
58602-445-09586020445091 BOTTLE in 1 CARTON (58602-445-09) / 30 TABLET in 1 BOTTLE1 bottle2015-08-050000-00-00NoNoCurrent
58602-445-15586020445151 BOTTLE in 1 CARTON (58602-445-15) / 60 TABLET in 1 BOTTLE1 bottle2015-08-050000-00-00NoNoCurrent
58602-445-17586020445171 BOTTLE in 1 CARTON (58602-445-17) / 45 TABLET in 1 BOTTLE1 bottle2015-08-050000-00-00NoNoCurrent
58602-445-19586020445191 BOTTLE in 1 CARTON (58602-445-19) / 90 TABLET in 1 BOTTLE1 bottle2015-08-050000-00-00NoNoCurrent
58602-445-215860204452110 BLISTER PACK in 1 CARTON (58602-445-21) / 10 TABLET in 1 BLISTER PACK10 blister pack2015-08-050000-00-00NoNoCurrent
58602-445-38586020445381 BOTTLE in 1 CARTON (58602-445-38) / 300 TABLET in 1 BOTTLE1 bottle2015-08-050000-00-00NoNoCurrent
58602-445-4058602044540500 TABLET in 1 BOTTLE (58602-445-40) 500 tablet2015-08-050000-00-00NoNoCurrent
58602-445-41586020445411000 TABLET in 1 BOTTLE (58602-445-41) 1000 tablet2015-08-050000-00-00NoNoCurrent
58602-445-475860204454775 TABLET in 1 PACKAGE, COMBINATION (58602-445-47) 75 tablet2015-08-050000-00-00NoNoCurrent
58602-445-54586020445541 BOTTLE in 1 CARTON (58602-445-54) / 70 TABLET in 1 BOTTLE1 bottle2015-08-050000-00-00NoNoCurrent
58602-445-60586020445601 BLISTER PACK in 1 CARTON (58602-445-60) / 5 TABLET in 1 BLISTER PACK1 blister pack2015-08-050000-00-00NoNoCurrent
58602-445-65586020445652 BLISTER PACK in 1 CARTON (58602-445-65) / 7 TABLET in 1 BLISTER PACK2 blister pack2019-11-210000-00-00NoNoCurrent
58602-445-94586020445941 BOTTLE in 1 CARTON (58602-445-94) / 100 TABLET in 1 BOTTLE1 bottle2015-08-050000-00-00NoNoCurrent