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    NDC 72572-0127-10 DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL Details

    DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL

    DEXMEDETOMIDINE HYDROCHLORIDE is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by CIVICA, INC.. The primary component is DEXMEDETOMIDINE HYDROCHLORIDE.

    Product Information

    NDC 72572-0127
    Product ID 72572-127_fb0759f3-818c-4e6e-9aa7-ac94f7d59de8
    Associated GPIs 60206030202020
    GCN Sequence Number 070876
    GCN Sequence Number Description dexmedetomidine in 0.9 % NaCl INFUS. BTL 200 MCG/50 INTRAVEN
    HIC3 H2E
    HIC3 Description SEDATIVE-HYPNOTICS,NON-BARBITURATE
    GCN 34538
    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 4
    Active Ingredient Units ug/mL
    Substance Name DEXMEDETOMIDINE HYDROCHLORIDE
    Labeler Name CIVICA, 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 ANDA212791
    Listing Certified Through 2024-12-31

    Package

    NDC 72572-0127-10 (72572012710)

    NDC Package Code 72572-127-10
    Billing NDC 72572012710
    Package 10 BOTTLE in 1 CARTON (72572-127-10) / 50 mL in 1 BOTTLE (72572-127-01)
    Marketing Start Date 2021-08-23
    NDC Exclude Flag N
    Pricing Information N/A