NDC 54838-571

Cetirizine Hydrochloride

Cetirizine Hydrochloride

Cetirizine Hydrochloride is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Lannett Company, Inc.. The primary component is Cetirizine Hydrochloride.

Product ID54838-571_083a0699-dc95-44fc-880d-168a6058d0a7
NDC54838-571
Product TypeHuman Prescription Drug
Proprietary NameCetirizine Hydrochloride
Generic NameCetirizine Hydrochloride
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2012-05-11
Marketing End Date2023-11-30
Marketing CategoryANDA / ANDA
Application NumberANDA078876
Labeler NameLannett Company, Inc.
Substance NameCETIRIZINE HYDROCHLORIDE
Active Ingredient Strength5 mg/5mL
Pharm ClassesHistamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC Exclude FlagN

Packaging

NDC 54838-571-40

120 mL in 1 BOTTLE, PLASTIC (54838-571-40)
Marketing Start Date2012-05-11
Marketing End Date2023-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54838-571-80 [54838057180]

Cetirizine Hydrochloride SYRUP
Marketing CategoryANDA
Application NumberANDA078876
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-05-11

NDC 54838-571-40 [54838057140]

Cetirizine Hydrochloride SYRUP
Marketing CategoryANDA
Application NumberANDA078876
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-05-11

Drug Details

Active Ingredients

IngredientStrength
CETIRIZINE HYDROCHLORIDE5 mg/5mL

OpenFDA Data

SPL SET ID:67da315b-ad29-4778-a990-9f837657f60b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1014673
    • UPC Code
  • 0354838572803
  • 0354838571806

    • 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.