Label: DEXMEDETOMIDINE HYDROCHLORIDE injection, solution, concentrate

  • NDC Code(s): 70771-1319-1, 70771-1319-7
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 12, 2020

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  • SPL UNCLASSIFIED SECTION

  • PRINCIPAL DISPLAY PANEL

    200 MCG/2 ML CONTAINER LABEL

    NDC 70771-1319-1

    Dexmedetomidine

    Hydrochloride Injection

    200 mcg/2 mL

    (100 mcg/mL)

    For Intravenous Infusion Use

    MUST BE DILUTED

    2 mL Single-Dose Vial

    Rx only

    Zydus Pharmaceuticals

    Dexmedetomidine Hydrochloride Injection - Container Label

    PRINCIPAL DISPLAY PANEL - 200 MCG/2 ML CARTON LABEL

    NDC 70771-1319-7

    Dexmedetomidine

    Hydrochloride Injection

    200 mcg/2 mL

    (100 mcg/mL)

    For Intravenous Infusion Use

    MUST BE DILUTED

    25 X 2 mL Single-Dose Vials

    Rx only

    Zydus Pharmaceuticals

    Dexmedetomidine Hydrochloride Injection - Carton Label
  • INGREDIENTS AND APPEARANCE
    DEXMEDETOMIDINE HYDROCHLORIDE 
    dexmedetomidine hydrochloride injection, solution, concentrate
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1319
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXMEDETOMIDINE HYDROCHLORIDE (UNII: 1018WH7F9I) (DEXMEDETOMIDINE - UNII:67VB76HONO) DEXMEDETOMIDINE100 ug  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 9 mg  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1319-725 in 1 CARTON06/14/2018
    1NDC:70771-1319-12 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20679806/14/2018
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1319) , MANUFACTURE(70771-1319)