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    NDC 17856-0507-01 Hydroxyzine Hydrochloride 10 mg/5mL Details

    Hydroxyzine Hydrochloride 10 mg/5mL

    Hydroxyzine Hydrochloride is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by ATLANTIC BIOLOGICALS CORP.. The primary component is HYDROXYZINE DIHYDROCHLORIDE.

    Product Information

    NDC 17856-0507
    Product ID 17856-0507_30938900-6c42-43b2-8727-1da44a520eba
    Associated GPIs
    GCN Sequence Number 070215
    GCN Sequence Number Description hydroxyzine HCl SOLUTION 10 MG/5 ML ORAL
    HIC3 Z2P
    HIC3 Description ANTIHISTAMINES - 1ST GENERATION
    GCN 33594
    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 SOLUTION
    Route ORAL
    Active Ingredient Strength 10
    Active Ingredient Units mg/5mL
    Substance Name HYDROXYZINE DIHYDROCHLORIDE
    Labeler Name ATLANTIC BIOLOGICALS CORP.
    Pharmaceutical Class Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA201674
    Listing Certified Through 2022-12-31

    Package

    NDC 17856-0507-01 (17856050701)

    NDC Package Code 17856-0507-1
    Billing NDC 17856050701
    Package 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0507-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0507-2)
    Marketing Start Date 2022-12-01
    NDC Exclude Flag N
    Pricing Information N/A