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    NDC 58602-0806-16 Cetirizine Hydrochloride (Allergy) 10 mg/1 Details

    Cetirizine Hydrochloride (Allergy) 10 mg/1

    Cetirizine Hydrochloride (Allergy) is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by Aurohealth LLC. The primary component is CETIRIZINE HYDROCHLORIDE.

    Product Information

    NDC 58602-0806
    Product ID 58602-806_926879b5-84de-436c-b0ed-3310c07b8523
    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 Hydrochloride (Allergy)
    Proprietary Name Suffix n/a
    Non-Proprietary Name Cetirizine Hydrochloride
    Product Type HUMAN OTC DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 10
    Active Ingredient Units mg/1
    Substance Name CETIRIZINE HYDROCHLORIDE
    Labeler Name Aurohealth LLC
    Pharmaceutical Class Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA209107
    Listing Certified Through 2024-12-31

    Package

    NDC 58602-0806-16 (58602080616)

    NDC Package Code 58602-806-16
    Billing NDC 58602080616
    Package 65 BOTTLE in 1 CARTON (58602-806-16) / 65 CAPSULE in 1 BOTTLE
    Marketing Start Date 2018-07-20
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL ffbca2a4-8df0-4c85-adf9-9414cd706fb2 Details

    Revised: 9/2020