NDC 57664-181

cetirizine hydrochloride

Cetirizine Hydrochloride

cetirizine hydrochloride is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Caraco Pharmaceutical Laboratories, Ltd.. The primary component is Cetirizine Hydrochloride.

Product ID57664-181_a0fe22f2-9063-49d4-831f-2271643b7d0a
NDC57664-181
Product TypeHuman Prescription Drug
Proprietary Namecetirizine hydrochloride
Generic NameCetirizine Hydrochloride
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2009-11-16
Marketing CategoryANDA / ANDA
Application NumberANDA090191
Labeler NameCaraco Pharmaceutical Laboratories, Ltd.
Substance NameCETIRIZINE HYDROCHLORIDE
Active Ingredient Strength1 mg/mL
Pharm ClassesHistamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 57664-181-31

120 mL in 1 BOTTLE, GLASS (57664-181-31)
Marketing Start Date2009-11-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57664-181-31 [57664018131]

cetirizine hydrochloride SYRUP
Marketing CategoryANDA
Application NumberANDA090191
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-16
Inactivation Date2019-10-21

NDC 57664-181-34 [57664018134]

cetirizine hydrochloride SYRUP
Marketing CategoryANDA
Application NumberANDA090191
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-16
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
CETIRIZINE HYDROCHLORIDE1 mg/mL

OpenFDA Data

SPL SET ID:23f3ec1c-bbba-49ef-b7d6-0be6e9424b99
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1014673

    • 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.