Label: EXTRANEAL- icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride injection, solution

  • NDC Code(s): 0941-0707-03, 0941-0707-08
  • Packager: Baxter Healthcare Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 16, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Health Care Provider Letter

    DHCP Letter - 1
    DHCP Letter - 2

    DHCP Letter - 3
    DHCP Letter - 4
    DHCP Letter - 5
    DHCP Letter - 6
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Extraneal Representative Carton Label

    FNB4974 2000 mL
    (APPROX 80 mL EXCESS)

    BaxterLogo

    EXTRANEAL Peritoneal Dialysis Solution with 7.5% lcodextrin
    EACH 100 mL CONTAINS

    7.5 g ICODEXTRIN 538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
    25.7 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (5.0 TO 6.0)
    mmol/LSODIUM 132 CALCIUM 1.75 MAGNESIUM 0.25 CHLORIDE 96 LACTATE 40
    OSMOLARITY284 mOsmol/L (CALC)
    STERILE NONPYROGENIC STORE BELOW 30°C SEE INSERT
    FOR INTRAPERITONEAL ADMINISTRATION ONLY NOT FOR INTRAVENOUS USE
    CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY
    DISCARD IF LEAKS ARE FOUND DO NOT USE UNLESS SOLUTION IS CLEAR
    DISCARD UNUSED PORTION KEEP OUT OF REACH OF CHILDREN
    MANUFACTURED BY
    BAXTER HEALTHCARE SA, SINGAPORE BRANCH
    2 WOODLANDS INDUSTRIAL PARK D STREET 2 SINGAPORE 737778
    (AN AFFILIATE OF BAXTER HEALTHCARE CORPORATION USA)
    DIRECTION TO BE USED AS DIRECTED BY PHYSICIAN
    FOR HONG KONG ONLY: PRESCRIPTION DRUG
    IMPORTED BY BAXTER HEALTHCARE (THAILAND) CO., LTD., BANGKOK
    FOR MALAYSIA ONLY: CONTROLLED MEDICINE. JAUHI DARIPADA KANAK-KANAK
    PRODUCT REGISTRATION HOLDER:
    BAXTER HEALTHCARE (MALAYSIA) SDN. BHD.,
    B-21-3A, THE ASCENT, PARADIGM, 1, JLN SS7/26A, 47301 PJ SELANGOR, MALAYSIA

    AMBU-FLEXCONTAINER PL-146
    SIN11220P MAL06021264AZ
    HK-46627 BRU13021011P

    THAI REG. NO. 2C 16/51 (N)

    EXTRANEAL, AMBU-FLEX and PL-146are trademarks of Baxter International Inc.

    Extraneal Representative Carton Label

    3A-00001
    FNB4974SG
    barcode
    7.5% ICODEXTRIN
    EXTRANEAL
    6 X 2000 ML
    MAL 06021264AZ

    LOT:
    barcode

    Barcode
    18806466013115

    LOT: S24A12345 EXP: 12.12.2024

  • INGREDIENTS AND APPEARANCE
    EXTRANEAL 
    icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0941-0707
    Route of AdministrationINTRAPERITONEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ICODEXTRIN (UNII: 2NX48Z0A9G) (ICODEXTRIN - UNII:2NX48Z0A9G) ICODEXTRIN7.5 g  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE538 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT) SODIUM LACTATE448 mg  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE25.7 mg  in 100 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE5.08 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0941-0707-086 in 1 CARTON12/11/2024
    1NDC:0941-0707-032000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug for use in drug shortage12/11/2024
    Labeler - Baxter Healthcare Corporation (005083209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vantive Manufacturing Pte. Ltd.599464843analysis(0941-0707) , label(0941-0707) , manufacture(0941-0707) , pack(0941-0707) , sterilize(0941-0707)