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    NDC 42023-0146-25 Dexmedetomidine Hydrochloride 100 ug/mL Details

    Dexmedetomidine Hydrochloride 100 ug/mL

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

    Product Information

    NDC 42023-0146
    Product ID 42023-146_ead5df8e-ba7b-4950-a358-76f555393965
    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 Hydrochloride
    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 Par Pharmaceutical, 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 ANDA203972
    Listing Certified Through 2024-12-31

    Package

    NDC 42023-0146-25 (42023014625)

    NDC Package Code 42023-146-25
    Billing NDC 42023014625
    Package 25 VIAL in 1 CARTON (42023-146-25) / 2 mL in 1 VIAL
    Marketing Start Date 2014-08-19
    NDC Exclude Flag N
    Pricing Information N/A