NDC 70518-0182

Cetirizine Hydrochloride

Cetirizine Hydrochloride

Cetirizine Hydrochloride is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Cetirizine Hydrochloride.

Product ID70518-0182_82c42112-5981-f059-e053-2991aa0a427a
NDC70518-0182
Product TypeHuman Otc Drug
Proprietary NameCetirizine Hydrochloride
Generic NameCetirizine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-01-27
Marketing CategoryANDA / ANDA
Application NumberANDA077829
Labeler NameREMEDYREPACK INC.
Substance NameCETIRIZINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-0182-1

30 TABLET in 1 BOTTLE, PLASTIC (70518-0182-1)
Marketing Start Date2017-02-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0182-5 [70518018205]

Cetirizine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077829
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-10-09
Marketing End Date2020-04-21

NDC 70518-0182-4 [70518018204]

Cetirizine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077829
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-06-09

NDC 70518-0182-2 [70518018202]

Cetirizine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077829
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-03-22
Marketing End Date2020-04-21

NDC 70518-0182-3 [70518018203]

Cetirizine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077829
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-03-31
Marketing End Date2018-04-14

NDC 70518-0182-0 [70518018200]

Cetirizine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077829
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-01-27
Marketing End Date2018-02-01

NDC 70518-0182-1 [70518018201]

Cetirizine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077829
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-02-21

Drug Details

Active Ingredients

IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:da2d7780-2c75-46f1-af2d-2d2bb371a993
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1014678
  • 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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