Search by Drug Name or NDC

    NDC 52584-0007-25 Hydroxyzine 50 mg/mL Details

    Hydroxyzine 50 mg/mL

    Hydroxyzine is a INTRAMUSCULAR INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by General Injectables & Vaccines, Inc. The primary component is HYDROXYZINE DIHYDROCHLORIDE.

    Product Information

    NDC 52584-0007
    Product ID 52584-007_f8ae6c2a-d456-4835-89a5-c388ae9eb1da
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    Proprietary Name Hydroxyzine
    Proprietary Name Suffix n/a
    Non-Proprietary Name Hydroxyzine
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAMUSCULAR
    Active Ingredient Strength 50
    Active Ingredient Units mg/mL
    Substance Name HYDROXYZINE DIHYDROCHLORIDE
    Labeler Name General Injectables & Vaccines, Inc
    Pharmaceutical Class Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA087408
    Listing Certified Through 2022-12-31

    Package

    NDC 52584-0007-25 (52584000725)

    NDC Package Code 52584-007-25
    Billing NDC 52584000725
    Package 1 VIAL, SINGLE-DOSE in 1 BAG (52584-007-25) / 2 mL in 1 VIAL, SINGLE-DOSE
    Marketing Start Date 2010-03-01
    NDC Exclude Flag N
    Pricing Information N/A
    << 52584-0002-34 52584-0010-20 >>

    Contents