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    NDC 63323-0474-01 Haloperidol 5 mg/mL Details

    Haloperidol 5 mg/mL

    Haloperidol is a INTRAMUSCULAR INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is HALOPERIDOL LACTATE.

    Product Information

    NDC 63323-0474
    Product ID 63323-474_f3409439-088d-49ec-9e10-c6c3b1a07eef
    Associated GPIs 59100010202005
    GCN Sequence Number 003970
    GCN Sequence Number Description haloperidol lactate VIAL 5 MG/ML INJECTION
    HIC3 H7O
    HIC3 Description ANTIPSYCHOTICS,DOPAMINE ANTAGONISTS,BUTYROPHENONES
    GCN 15500
    HICL Sequence Number 001661
    HICL Sequence Number Description HALOPERIDOL LACTATE
    Brand/Generic Generic
    Proprietary Name Haloperidol
    Proprietary Name Suffix n/a
    Non-Proprietary Name HALOPERIDOL LACTATE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAMUSCULAR
    Active Ingredient Strength 5
    Active Ingredient Units mg/mL
    Substance Name HALOPERIDOL LACTATE
    Labeler Name Fresenius Kabi USA, LLC
    Pharmaceutical Class Typical Antipsychotic [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA075689
    Listing Certified Through 2024-12-31

    Package

    NDC 63323-0474-01 (63323047401)

    NDC Package Code 63323-474-01
    Billing NDC 63323047401
    Package 25 VIAL in 1 TRAY (63323-474-01) / 1 mL in 1 VIAL (63323-474-00)
    Marketing Start Date 2000-10-20
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL b1ad2abd-a9d6-44e3-957b-36a73260f4f5 Details

    Revised: 1/2022