Label: ARSENIC TRIOXIDE injection, solution

  • NDC Code(s): 49315-007-01, 49315-007-10
  • 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

    PRINCIPAL DISPLAY PANEL - Vial Label

    NDC 49315-007-01

    Arsenic Trioxide Injection

    12 mg/6 mL

    (2 mg/mL)

    NEW CONCENTRATION

    For Intravenous Use Only

    Cytotoxic Agent

    6 mL Single-Dose Vial

    Rx only

    Zydus Pharmaceuticals

    vial label

    PRINCIPAL DISPLAY PANEL - Carton Label

    NDC 49315-007-10

    Arsenic Trioxide Injection

    12 mg/6 mL

    (2 mg/mL)

    NEW CONCENTRATION

    For Intravenous Use Only

    10 X 6 mL Single-Dose Vials

    Rx only

    Zydus Pharmaceuticals

    carton label
  • INGREDIENTS AND APPEARANCE
    ARSENIC TRIOXIDE 
    arsenic trioxide injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49315-007
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49315-007-1010 in 1 CARTON09/03/2019
    1NDC:49315-007-016 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20622809/03/2019
    Labeler - Cadila Healthcare Limited (650348852)
    Registrant - Cadila Healthcare Limited (650348852)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited650348852ANALYSIS(49315-007) , MANUFACTURE(49315-007)