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    NDC 41167-3530-01 Childrens Xyzal Allergy 2.5 mg/5mL Details

    Childrens Xyzal Allergy 2.5 mg/5mL

    Childrens Xyzal Allergy is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Chattem, Inc.. The primary component is LEVOCETIRIZINE DIHYDROCHLORIDE.

    Product Information

    NDC 41167-3530
    Product ID 41167-3530_473ef9ed-1b34-48a3-9438-75ebf10c321a
    Associated GPIs 41550027102020
    GCN Sequence Number 062168
    GCN Sequence Number Description levocetirizine dihydrochloride SOLUTION 2.5 MG/5ML ORAL
    HIC3 Z2Q
    HIC3 Description ANTIHISTAMINES - 2ND GENERATION
    GCN 97950
    HICL Sequence Number 022959
    HICL Sequence Number Description LEVOCETIRIZINE DIHYDROCHLORIDE
    Brand/Generic Brand
    Proprietary Name Childrens Xyzal Allergy
    Proprietary Name Suffix n/a
    Non-Proprietary Name Levocetirizine dihydrochloride
    Product Type HUMAN OTC DRUG
    Dosage Form SOLUTION
    Route ORAL
    Active Ingredient Strength 2.5
    Active Ingredient Units mg/5mL
    Substance Name LEVOCETIRIZINE DIHYDROCHLORIDE
    Labeler Name Chattem, Inc.
    Pharmaceutical Class Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA209090
    Listing Certified Through 2024-12-31

    Package

    NDC 41167-3530-01 (41167353001)

    NDC Package Code 41167-3530-1
    Billing NDC 41167353001
    Package 1 BOTTLE in 1 CARTON (41167-3530-1) / 148 mL in 1 BOTTLE
    Marketing Start Date 2023-02-01
    NDC Exclude Flag N
    Pricing Information N/A