Label: ALBUMINAR-20 (albumin- human solution

  • NDC Code(s): 0053-7695-33, 0053-7695-34, 0053-7695-90, 0053-7695-91
  • Packager: CSL Behring LLC
  • Category: PLASMA DERIVATIVE
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated November 23, 2016

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  • PRINCIPAL DISPLAY PANEL - 50 mL Vial Label

    NDC 0053-7695-90

    20%

    50 mL

    Albumin (Human)
    USP 20%
    Albuminar®-20

    Store between 20-25°C (68-77°F);
    excursions permitted to 15-30°C (59-86°F)
    [See USP Controlled Room Temperature].

    Rx only
    I.V. use only

    Manufactured by:
    CSL Behring LLC
    Kankakee, IL 60901 USA
    US License No. 1767

    PRINCIPAL DISPLAY PANEL - 50 mL Vial Label
  • PRINCIPAL DISPLAY PANEL - 50 mL Vial Carton

    NDC 0053-7695-33

    20%

    50 mL

    Albumin (Human)
    USP 20%
    Albuminar®-20

    For Intravenous Administration Only.

    10 g in 50 mL solution osmotically equivalent to
    200 mL of plasma.

    Do not use if turbid.

    Do not begin administration more than 4 hours
    after the container has been entered.

    Store between 20-25°C (68-77°F); excursions
    permitted to 15-30°C (59-86°F) [See USP
    Controlled Room Temperature].

    Rx only

    Manufactured by:
    CSL Behring LLC
    Kankakee, IL 60901 USA
    US License No. 1767

    CSL Behring

    PRINCIPAL DISPLAY PANEL - 50 mL Vial Carton
  • INGREDIENTS AND APPEARANCE
    ALBUMINAR-20 
    albumin (human) solution
    Product Information
    Product TypePLASMA DERIVATIVEItem Code (Source)NDC:0053-7695
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Albumin Human (UNII: ZIF514RVZR) (Albumin Human - UNII:ZIF514RVZR) Albumin Human20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    sodium chloride (UNII: 451W47IQ8X)  
    Sodium bicarbonate (UNII: 8MDF5V39QO)  
    Sodium hydroxide (UNII: 55X04QC32I)  
    Acetic Acid (UNII: Q40Q9N063P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0053-7695-331 in 1 CARTON
    1NDC:0053-7695-9050 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    2NDC:0053-7695-341 in 1 CARTON
    2NDC:0053-7695-91100 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only01/06/2009
    Labeler - CSL Behring LLC (058268293)
    Establishment
    NameAddressID/FEIBusiness Operations
    CSL Behring LLC058268293MANUFACTURE