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    NDC 72789-0216-40 Hydroxyzine Hydrochloride 25 mg/1 Details

    Hydroxyzine Hydrochloride 25 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 72789-0216
    Product ID 72789-216_0322ef5c-632f-d1e6-e063-6294a90a417a
    Associated GPIs 57200040100310
    GCN Sequence Number 003728
    GCN Sequence Number Description hydroxyzine HCl TABLET 25 MG ORAL
    HIC3 Z2P
    HIC3 Description ANTIHISTAMINES - 1ST GENERATION
    GCN 13943
    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 25
    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 ANDA088618
    Listing Certified Through 2024-12-31

    Package

    NDC 72789-0216-40 (72789021640)

    NDC Package Code 72789-216-40
    Billing NDC 72789021640
    Package 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-40)
    Marketing Start Date 2021-11-18
    NDC Exclude Flag N
    Pricing Information N/A