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    NDC 00338-9555-24 DEXMEDETOMIDINE HYDROCHLORIDE 200 ug/50mL Details

    DEXMEDETOMIDINE HYDROCHLORIDE 200 ug/50mL

    DEXMEDETOMIDINE HYDROCHLORIDE is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Baxter Healthcare Company. The primary component is DEXMEDETOMIDINE HYDROCHLORIDE.

    Product Information

    NDC 00338-9555
    Product ID 0338-9555_d9037c6e-d0d0-45a2-8688-e2f231a9fcdc
    Associated GPIs 60206030202020
    GCN Sequence Number 078787
    GCN Sequence Number Description dexmedetomidine in 0.9 % NaCl PLAST. BAG 200 MCG/50 INTRAVEN
    HIC3 H2E
    HIC3 Description SEDATIVE-HYPNOTICS,NON-BARBITURATE
    GCN 45178
    HICL Sequence Number 040230
    HICL Sequence Number Description DEXMEDETOMIDINE HCL IN 0.9 % SODIUM CHLORIDE
    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
    Route INTRAVENOUS
    Active Ingredient Strength 200
    Active Ingredient Units ug/50mL
    Substance Name DEXMEDETOMIDINE HYDROCHLORIDE
    Labeler Name Baxter Healthcare Company
    Pharmaceutical Class Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA208532
    Listing Certified Through 2024-12-31

    Package

    NDC 00338-9555-24 (00338955524)

    NDC Package Code 0338-9555-24
    Billing NDC 00338955524
    Package 24 BAG in 1 CARTON (0338-9555-24) / 50 mL in 1 BAG
    Marketing Start Date 2018-08-21
    NDC Exclude Flag N
    Pricing Information N/A