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    NDC 66794-0233-42 Dexmedetomidine 200 ug/2mL Details

    Dexmedetomidine 200 ug/2mL

    Dexmedetomidine is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Piramal Critical Care Inc. The primary component is DEXMEDETOMIDINE HYDROCHLORIDE.

    Product Information

    NDC 66794-0233
    Product ID 66794-233_0d08873b-53a6-29e1-e063-6394a90ac159
    Associated GPIs 60206030102020
    GCN Sequence Number 044671
    GCN Sequence Number Description dexmedetomidine HCl VIAL 200MCG/2ML INTRAVEN
    HIC3 H2E
    HIC3 Description SEDATIVE-HYPNOTICS,NON-BARBITURATE
    GCN 42360
    HICL Sequence Number 020971
    HICL Sequence Number Description DEXMEDETOMIDINE HCL
    Brand/Generic Generic
    Proprietary Name Dexmedetomidine
    Proprietary Name Suffix n/a
    Non-Proprietary Name Dexmedetomidine
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 200
    Active Ingredient Units ug/2mL
    Substance Name DEXMEDETOMIDINE HYDROCHLORIDE
    Labeler Name Piramal Critical Care Inc
    Pharmaceutical Class Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA202126
    Listing Certified Through 2024-12-31

    Package

    NDC 66794-0233-42 (66794023342)

    NDC Package Code 66794-233-42
    Billing NDC 66794023342
    Package 25 VIAL, GLASS in 1 CARTON (66794-233-42) / 2 mL in 1 VIAL, GLASS (66794-233-02)
    Marketing Start Date 2021-05-01
    NDC Exclude Flag N
    Pricing Information N/A