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    NDC 00409-1638-02 Precedex 100 ug/mL Details

    Precedex 100 ug/mL

    Precedex is a INTRAVENOUS INJECTION, SOLUTION, CONCENTRATE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hospira, Inc.. The primary component is DEXMEDETOMIDINE HYDROCHLORIDE.

    Product Information

    NDC 00409-1638
    Product ID 0409-1638_ffeff440-1322-4851-921f-e5b74e675fbf
    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 Brand
    Proprietary Name Precedex
    Proprietary Name Suffix n/a
    Non-Proprietary Name DEXMEDETOMIDINE HYDROCHLORIDE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION, CONCENTRATE
    Route INTRAVENOUS
    Active Ingredient Strength 100
    Active Ingredient Units ug/mL
    Substance Name DEXMEDETOMIDINE HYDROCHLORIDE
    Labeler Name Hospira, Inc.
    Pharmaceutical Class Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA021038
    Listing Certified Through 2024-12-31

    Package

    NDC 00409-1638-02 (00409163802)

    NDC Package Code 0409-1638-02
    Billing NDC 00409163802
    Package 25 VIAL in 1 TRAY (0409-1638-02) / 2 mL in 1 VIAL (0409-1638-32)
    Marketing Start Date 2004-11-30
    NDC Exclude Flag N
    Pricing Information N/A