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    NDC 63323-0471-05 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 Fresenius Kabi USA, LLC. The primary component is HALOPERIDOL DECANOATE.

    Product Information

    NDC 63323-0471
    Product ID 63323-471_ffe1197b-99e4-4dee-922e-d1b528d84052
    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 Fresenius Kabi USA, LLC
    Pharmaceutical Class Typical Antipsychotic [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA074893
    Listing Certified Through 2024-12-31

    Package

    NDC 63323-0471-05 (63323047105)

    NDC Package Code 63323-471-05
    Billing NDC 63323047105
    Package 1 VIAL, MULTI-DOSE in 1 CARTON (63323-471-05) / 5 mL in 1 VIAL, MULTI-DOSE
    Marketing Start Date 2000-07-12
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 22.6047
    Pricing Unit ML
    Effective Date 2022-11-23
    NDC Description HALOPERIDOL DEC 100 MG/ML VIAL
    Pharmacy Type Indicator C/I
    OTC N
    Explanation Code 1, 5
    Classification for Rate Setting G
    As of Date 2022-11-23
    This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

    Standard Product Labeling (SPL)/Prescribing Information SPL 262456c4-47e5-4713-8379-844f8f587495 Details

    Revised: 11/2021