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    NDC 43063-0519-30 Hydroxyzine Hydrochloride 50 mg/1 Details

    Hydroxyzine Hydrochloride 50 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 43063-0519
    Product ID 43063-519_f6060b10-fe5a-8fcc-e053-2a95a90a5e1f
    Associated GPIs 57200040100315
    GCN Sequence Number 003729
    GCN Sequence Number Description hydroxyzine HCl TABLET 50 MG ORAL
    HIC3 Z2P
    HIC3 Description ANTIHISTAMINES - 1ST GENERATION
    GCN 13944
    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 50
    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 ANDA040788
    Listing Certified Through 2024-12-31

    Package

    NDC 43063-0519-30 (43063051930)

    NDC Package Code 43063-519-30
    Billing NDC 43063051930
    Package 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-519-30)
    Marketing Start Date 2012-07-25
    NDC Exclude Flag N
    Pricing Information N/A