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    NDC 43063-0960-82 Hydroxyzine Hydrochloride 10 mg/1 Details

    Hydroxyzine Hydrochloride 10 mg/1

    Hydroxyzine Hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PD-Rx Pharmaceuticals, Inc.. The primary component is HYDROXYZINE DIHYDROCHLORIDE.

    Product Information

    NDC 43063-0960
    Product ID 43063-960_00261ccc-8927-ed9b-e063-6294a90a23b6
    Associated GPIs 57200040100305
    GCN Sequence Number 003726
    GCN Sequence Number Description hydroxyzine HCl TABLET 10 MG ORAL
    HIC3 Z2P
    HIC3 Description ANTIHISTAMINES - 1ST GENERATION
    GCN 13941
    HICL Sequence Number 001608
    HICL Sequence Number Description HYDROXYZINE HCL
    Brand/Generic Generic
    Proprietary Name Hydroxyzine Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name hydroxyzine hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 10
    Active Ingredient Units mg/1
    Substance Name HYDROXYZINE DIHYDROCHLORIDE
    Labeler Name PD-Rx Pharmaceuticals, Inc.
    Pharmaceutical Class Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA040786
    Listing Certified Through 2024-12-31

    Package

    NDC 43063-0960-82 (43063096082)

    NDC Package Code 43063-960-82
    Billing NDC 43063096082
    Package 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-960-82)
    Marketing Start Date 2019-04-01
    NDC Exclude Flag N
    Pricing Information N/A