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    NDC 67457-0381-58 Haloperidol Decanoate 100 mg/mL Details

    Haloperidol Decanoate 100 mg/mL

    Haloperidol Decanoate is a INTRAMUSCULAR INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Institutional LLC. The primary component is HALOPERIDOL DECANOATE.

    Product Information

    NDC 67457-0381
    Product ID 67457-381_c0d3dc0a-61bd-40ee-87b1-1d4ae489cd52
    Associated GPIs 59100010302020
    GCN Sequence Number 011876
    GCN Sequence Number Description haloperidol decanoate VIAL 100 MG/ML INTRAMUSC
    HIC3 H7O
    HIC3 Description ANTIPSYCHOTICS,DOPAMINE ANTAGONISTS,BUTYROPHENONES
    GCN 14781
    HICL Sequence Number 001660
    HICL Sequence Number Description HALOPERIDOL DECANOATE
    Brand/Generic Generic
    Proprietary Name Haloperidol Decanoate
    Proprietary Name Suffix n/a
    Non-Proprietary Name Haloperidol Decanoate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION
    Route INTRAMUSCULAR
    Active Ingredient Strength 100
    Active Ingredient Units mg/mL
    Substance Name HALOPERIDOL DECANOATE
    Labeler Name Mylan Institutional LLC
    Pharmaceutical Class Typical Antipsychotic [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA075440
    Listing Certified Through n/a

    Package

    NDC 67457-0381-58 (67457038158)

    NDC Package Code 67457-381-58
    Billing NDC 67457038158
    Package 5 VIAL in 1 CARTON (67457-381-58) / 5 mL in 1 VIAL (67457-381-00)
    Marketing Start Date 2014-03-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 8ffac6fb-1702-40d6-b085-152d24673cbd Details

    Revised: 2/2021