NDC 52959-923

CETIRIZINE HYDROCHLORIDE

Cetirizine Hydrochloride

CETIRIZINE HYDROCHLORIDE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by H. J. Harkins Company Inc.. The primary component is Cetirizine Hydrochloride.

Product ID52959-923_5f4e05af-61a5-7f84-e053-2a91aa0ac6f6
NDC52959-923
Product TypeHuman Prescription Drug
Proprietary NameCETIRIZINE HYDROCHLORIDE
Generic NameCetirizine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-01-03
Marketing CategoryANDA / ANDA
Application NumberANDA077946
Labeler NameH. J. Harkins Company Inc.
Substance NameCETIRIZINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesHistamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 52959-923-14

14 TABLET in 1 CONTAINER (52959-923-14)
Marketing Start Date2017-01-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-923-07 [52959092307]

CETIRIZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA077946
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-923-30 [52959092330]

CETIRIZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA077946
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-923-14 [52959092314]

CETIRIZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA077946
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-923-15 [52959092315]

CETIRIZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA077946
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-923-20 [52959092320]

CETIRIZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA077946
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-923-90 [52959092390]

CETIRIZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA077946
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-923-10 [52959092310]

CETIRIZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA077946
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-923-60 [52959092360]

CETIRIZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA077946
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:5f4e05af-61a4-7f84-e053-2a91aa0ac6f6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1014678

    • Pharmacological Class

    • Histamine H1 Receptor Antagonists [MoA]
    • Histamine-1 Receptor Antagonist [EPC]

    NDC Crossover Matching brand name "CETIRIZINE HYDROCHLORIDE" or generic name "Cetirizine Hydrochloride"

    NDCBrand NameGeneric Name
    0121-4780Cetirizine HydrochlorideCetirizine Hydrochloride
    0179-8301Cetirizine HydrochlorideCetirizine Hydrochloride
    0179-8302Cetirizine HydrochlorideCetirizine Hydrochloride
    0363-0471Cetirizine HydrochlorideCetirizine Hydrochloride
    0363-9899Cetirizine HydrochlorideCetirizine Hydrochloride
    0378-3635Cetirizine Hydrochloridecetirizine hydrochloride
    67668-161Cetirizine HydrochlorideCetirizine Hydrochloride
    67668-162Cetirizine HydrochlorideCetirizine Hydrochloride
    68016-353Cetirizine HydrochlorideCetirizine Hydrochloride
    68016-939Cetirizine HydrochlorideCetirizine Hydrochloride
    68071-1964Cetirizine HydrochlorideCetirizine Hydrochloride
    68071-1988Cetirizine HydrochlorideCetirizine Hydrochloride
    68151-1008Cetirizine HydrochlorideCetirizine Hydrochloride
    68151-3708Cetirizine HydrochlorideCetirizine Hydrochloride
    68788-0790Cetirizine HydrochlorideCetirizine Hydrochloride
    68788-6905Cetirizine HydrochlorideCetirizine Hydrochloride
    68788-9493Cetirizine HydrochlorideCetirizine Hydrochloride
    68788-9734Cetirizine HydrochlorideCetirizine Hydrochloride
    68788-9985Cetirizine hydrochlorideCetirizine hydrochloride
    68998-939Cetirizine HydrochlorideCetirizine Hydrochloride
    0536-1041Cetirizine HydrochlorideCetirizine Hydrochloride
    0536-4088Cetirizine HydrochlorideCetirizine Hydrochloride
    70518-0182Cetirizine HydrochlorideCetirizine Hydrochloride
    70518-0664Cetirizine HydrochlorideCetirizine Hydrochloride
    70518-0777Cetirizine HydrochlorideCetirizine Hydrochloride
    70518-0910Cetirizine HydrochlorideCetirizine Hydrochloride
    70518-1989Cetirizine HydrochlorideCetirizine Hydrochloride
    70985-002Cetirizine HydrochlorideCetirizine Hydrochloride
    71141-133Cetirizine HydrochlorideCetirizine Hydrochloride
    70934-199Cetirizine HydrochlorideCetirizine Hydrochloride
    71141-000Cetirizine HydrochlorideCetirizine Hydrochloride
    71205-164Cetirizine HydrochlorideCetirizine Hydrochloride
    70985-001Cetirizine HydrochlorideCetirizine Hydrochloride
    71205-207cetirizine hydrochloridecetirizine hydrochloride
    71335-0028Cetirizine HydrochlorideCetirizine Hydrochloride
    71335-0300Cetirizine HydrochlorideCetirizine Hydrochloride
    71205-093Cetirizine HydrochlorideCetirizine Hydrochloride
    71335-0755Cetirizine HydrochlorideCetirizine Hydrochloride
    71610-048CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDE
    71610-093Cetirizine HydrochlorideCetirizine Hydrochloride
    0615-8240cetirizine hydrochloridecetirizine hydrochloride
    0781-1684Cetirizine HydrochlorideCetirizine Hydrochloride
    0781-1683Cetirizine HydrochlorideCetirizine Hydrochloride
    0781-5284Cetirizine HydrochlorideCetirizine Hydrochloride
    0781-5283Cetirizine HydrochlorideCetirizine Hydrochloride
    0904-5852Cetirizine HydrochlorideCetirizine Hydrochloride
    0904-5879Cetirizine HydrochlorideCetirizine Hydrochloride
    0904-6100Cetirizine hydrochlorideCetirizine hydrochloride
    10544-670Cetirizine HydrochlorideCetirizine Hydrochloride
    12634-987CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDE
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