Label: RAXIBACUMAB- raxibacumab injection

  • NDC Code(s): 63379-060-00, 63379-061-00
  • Packager: Glaxo Operations UK Ltd
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT

Drug Label Information

Updated December 5, 2017

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  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    NDC 49401-104-01

    RAXIBACUMAB

    Injection

    1700 mg/34mL

    (50 mg/mL)

    For Intravenous Infusion

    Must be Diluted Prior To Use

    Rx only

    Single-Use Vial; Discard unused portion

    ATTENTION: Confirm expiration date on carton prior to removing vial. Before use apply enclosed label to vial over the existing label.

    34 mL

    For Strategic National Stockpile Use Only

    10000000115020 Rev. 3/13

    Raxibacumab 34 mL vial carton
    Close
  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    NDC 49401-103-01

    Raxibacumab

    Injection

    1700 mg/34mL

    (50 mg/mL)

    For Intravenous Infusion

    Must be Diluted Prior To Use

    Rx only

    Single-Use Vial

    Discard unused portion.

    34 mL

    Rev. 11/15

    10000000137037

    Raxibacumab 34 mL carton
    Close
  • INGREDIENTS AND APPEARANCE
    RAXIBACUMAB 
    raxibacumab injection
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63379-060
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    RAXIBACUMAB (UNII: 794PGL549S) (RAXIBACUMAB - UNII:794PGL549S) RAXIBACUMAB 50 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCINE (UNII: TE7660XO1C)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63379-060-00 1 in 1 CARTON 03/23/2016
    1 34 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Approved Drug Product Manufactured Under Contract BLA125349 03/23/2016
    RAXIBACUMAB 
    raxibacumab injection
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63379-061
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    RAXIBACUMAB (UNII: 794PGL549S) (RAXIBACUMAB - UNII:794PGL549S) RAXIBACUMAB 50 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCINE (UNII: TE7660XO1C)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63379-061-00 1 in 1 CARTON 03/23/2016
    1 34 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Approved Drug Product Manufactured Under Contract BLA125349 03/23/2016
    Labeler - Glaxo Operations UK Ltd (424738227)
    Close