FDA.reportPublic FDA data

Cetirizine Hydrochloride (Allergy)

Product NDC
58602-806
11-digit product format
586020806
Labeler code
58602
Product ID
58602-806_a74bd49f-8718-4483-9019-b761138669c9
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA209107
Marketing category
ANDA
Marketing start
2018-07-20
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cetirizine Hydrochloride (Allergy)
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014675

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
58602-806-04Cetirizine Hydrochloride (Allergy)12 in 1 BOTTLECAPSULE124
58602-806-04Cetirizine Hydrochloride (Allergy)1 in 1 CARTONCAPSULE14
58602-806-12Cetirizine Hydrochloride (Allergy)40 in 1 BOTTLECAPSULE404
58602-806-12Cetirizine Hydrochloride (Allergy)1 in 1 CARTONCAPSULE14
58602-806-16Cetirizine Hydrochloride (Allergy)65 in 1 CARTONCAPSULE654
58602-806-16Cetirizine Hydrochloride (Allergy)65 in 1 BOTTLECAPSULE654
58602-806-53Cetirizine Hydrochloride (Allergy)25 in 1 BOTTLECAPSULE254
58602-806-53Cetirizine Hydrochloride (Allergy)1 in 1 CARTONCAPSULE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-806CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) CAPSULE [AUROHEALTH LLC]3Current NDC, Legacy NDC, 8 package rows20200915_ffbca2a4-8df0-4c85-adf9-9414cd706fb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSNffbca2a4-8df0-4c85-adf9-9414cd706fb24
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCDffbca2a4-8df0-4c85-adf9-9414cd706fb24
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSYffbca2a4-8df0-4c85-adf9-9414cd706fb24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-806-04586020806041 BOTTLE in 1 CARTON (58602-806-04) / 12 CAPSULE in 1 BOTTLE1 bottle2018-07-200000-00-00NoNoCurrent
58602-806-12586020806121 BOTTLE in 1 CARTON (58602-806-12) / 40 CAPSULE in 1 BOTTLE1 bottle2018-07-200000-00-00NoNoCurrent
58602-806-165860208061665 BOTTLE in 1 CARTON (58602-806-16) / 65 CAPSULE in 1 BOTTLE65 bottle2018-07-200000-00-00NoNoCurrent
58602-806-53586020806531 BOTTLE in 1 CARTON (58602-806-53) / 25 CAPSULE in 1 BOTTLE1 bottle2018-07-200000-00-00NoNoCurrent