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    NDC 51655-0194-52 Cetirizine 10 mg/1 Details

    Cetirizine 10 mg/1

    Cetirizine is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Northwind Pharmaceuticals, LLC. The primary component is CETIRIZINE HYDROCHLORIDE.

    Product Information

    NDC 51655-0194
    Product ID 51655-194_f6cac2f0-b486-cfde-e053-6294a90ae2f3
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    Proprietary Name Cetirizine
    Proprietary Name Suffix n/a
    Non-Proprietary Name Cetirizine Hydrochloride
    Product Type HUMAN OTC DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 10
    Active Ingredient Units mg/1
    Substance Name CETIRIZINE HYDROCHLORIDE
    Labeler Name Northwind Pharmaceuticals, LLC
    Pharmaceutical Class Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA078336
    Listing Certified Through 2024-12-31

    Package

    NDC 51655-0194-52 (51655019452)

    NDC Package Code 51655-194-52
    Billing NDC 51655019452
    Package 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-194-52)
    Marketing Start Date 2023-03-02
    NDC Exclude Flag N
    Pricing Information N/A