NDC 0378-3635

Cetirizine Hydrochloride

Cetirizine Hydrochloride

Cetirizine Hydrochloride is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Cetirizine Hydrochloride.

Product ID0378-3635_26254cf3-0b23-4d09-b428-ff14d4ec3761
NDC0378-3635
Product TypeHuman Otc Drug
Proprietary NameCetirizine Hydrochloride
Generic NameCetirizine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2007-12-27
Marketing CategoryANDA / ANDA
Application NumberANDA076677
Labeler NameMylan Pharmaceuticals Inc.
Substance NameCETIRIZINE HYDROCHLORIDE
Active Ingredient Strength5 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0378-3635-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3635-01)
Marketing Start Date2007-12-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-3635-01 [00378363501]

Cetirizine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076677
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2007-12-27

NDC 0378-3635-05 [00378363505]

Cetirizine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076677
Product TypeHUMAN OTC DRUG
Marketing Start Date2007-12-27
Marketing End Date2014-04-11

Drug Details

Active Ingredients

IngredientStrength
CETIRIZINE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:487ae0f0-320c-4534-b9e2-0e215f167cea
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1014676
  • 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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