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

  • NDC Code(s): 0941-0681-02, 0941-0681-08, 0941-0719-01, 0941-0719-05
  • Packager: Vantive US Healthcare LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Unapproved drug for use in drug shortage

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 May 7, 2025

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  • Health Care Provider Letter

    Extraneal DHCP Letter-1
    Extraneal DHCP Letter-2
    Extraneal DHCP Letter-3
    Extraneal DHCP Letter-4
    Extraneal DHCP Letter-5
    Extraneal DHCP Letter-6
    Extraneal DHCP Letter-7
    Extraneal DHCP Letter-8
    Extraneal DHCP Letter-9
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Representative Extraneal Container Label

    Lot EXP
    B4938R 2000 ml
    Baxter
    EXTRANEAL Solution for Peritoneal Dialysis

    Formula 1000 ml

    mmol/l

    Icodextrin

    75 g

    Na+

    133

    Sodium Chloride

    5,4 g

    Ca++

    1,75

    Sodium (S)-lactate

    4,5 g

    Mg++

    0,25

    Calcium Chloride 2H 20

    0,257 g

    Clˉ

    96

    Magnesium Chloride 6H 20

    0,051 g

    C 3H 50 3ˉ

    40

    Water for Injections

    Osmolarity

    284mOsm/l

    Hydrochloric acid or sodium hydroxide (for pH adjustment)

    pH

    5,0 – 6,0

    For intraperitoneal use
    Not for intravenous use
    Use as directed by a physician
    Read the package leaflet before use
    Keep out of the sight and reach of children
    Nonpyrogenic
    Do not store below 4°C
    Do not use unless solution is clear and container undamaged
    For single use only
    Once removed from the overpouch use immediately
    Discard unused solution

    UK:
    Baxter Healthcare Ltd
    Caxton Way, Thetford, Norfolk, IP24 3SE,
    United Kingdom

    IE and MT:
    Baxter Holding B.V.,
    Kobaltweg 49, 3542CE,
    Utrecht, Netherlands

    PL 00116/0266
    PA 2299/017/001
    MA 1277/01101

    POM Symbol

    Manufactured by Baxter Healthcare S A IRL-Castlebar CB-35-04-605

    Representative Extraneal Carton Label

    EXTRANEAL
    FPB4938RC
    2000 ml x 5

    Solution for Peritoneal Dialysis

    1000 ml

    Icodextrin

    75 g

    Sodium Chloride

    5,4 g

    Sodium (S)-lactate

    4,5 g

    Calcium Chloride 2H 20

    0,257 g

    Magnesium Chloride 6H 20

    0,051 g

    Water for injections to 1000 ml

    Sodium hydroxide or hydrochloric acid (for pH adjustment)

    For intraperitoneal use
    Not for intravenous infusion
    Keep out of the sight and reach of children

    UK: Baxter Healthcare Limited Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom
    IE and MT: Baxter Holding B.V. Kobaltweg 49, 3542CE, Utrecht, Netherlands

    88-46-13-193

    Lot: EXP

    Do not store below 4°C

    Single bag with Luer connector

    MA 1277/01101
    PA 2299/017/001
    PL 00116/0266

    POM Symbol

    Barcode
    (01)55413760441875(17)201200(10)88C88C88B2

    EXTRANEAL
    FPB4938RC
    2000 ml x 5

    Lot: EXP

    Vantive Representative Extraneal Container Label

    Lot EXP
    B4938R 2000 ml
    Vantive
    EXTRANEAL Solution for Peritoneal Dialysis

    Formula 1000 ml

    mmol/l

    Icodextrin

    75 g

    Na+

    133

    Sodium Chloride

    5,4 g

    Ca++

    1,75

    Sodium (S)-lactate

    4,5 g

    Mg++

    0,25

    Calcium Chloride 2H 20

    0,257 g

    Clˉ

    96

    Magnesium Chloride 6H 20

    0,051 g

    C 3H 50 3ˉ

    40

    Water for Injections

    Osmolarity

    284mOsm/l

    Hydrochloric acid or sodium hydroxide (for pH adjustment)

    pH

    5,0 – 6,0

    For intraperitoneal use
    Not for intravenous use
    Use as directed by a physician
    Read the package leaflet before use
    Keep out of the sight and reach of children
    Nonpyrogenic
    Do not store below 4°C
    Do not use unless solution is clear and container undamaged
    For single use only
    Once removed from the overpouch use immediately
    Discard unused solution

    Vantive Limited
    Wavertree Technology Park
    2 Wavertree Boulevard
    Liverpool, L7 9PE
    United Kingdom

    PL 58711/0005

    POM Symbol

    CB-35-05-248

    Vantive Representative Extraneal Carton Label

    EXTRANEAL
    FPB4938RC
    2000 ml x 5

    Solution for Peritoneal Dialysis

    1000 ml

    Icodextrin

    75 g

    Sodium Chloride

    5,4 g

    Sodium (S)-lactate

    4,5 g

    Calcium Chloride 2H 20

    0,257 g

    Magnesium Chloride 6H 20

    0,051 g

    Water for injections to 1000 ml

    Sodium hydroxide or hydrochloric acid (for pH adjustment)

    For intraperitoneal use
    Not for intravenous infusion
    Keep out of the sight and reach of children

    Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom

    88-46-14-004

    Lot: EXP

    UK Only

    Do not store below 4°C

    Single bag with Luer connector

    PL 58711/0005

    POM Symbol

    Barcode
    (01)57332414202786(17)201200(10)88C88C88B2

    EXTRANEAL
    FPB4938RC
    2000 ml x 5

    Lot: EXP

    Representative Extraneal Container Label

    Lot EXP
    B4945R 2500 ml
    Baxter
    EXTRANEAL Solution for Peritoneal Dialysis

    Formula 1000 ml

    mmol/l

    Icodextrin

    75 g

    Na+

    133

    Sodium Chloride

    5,4 g

    Ca++

    1,75

    Sodium (S)-lactate

    4,5 g

    Mg++

    0,25

    Calcium Chloride 2H 20

    0,257 g

    Clˉ

    96

    Magnesium Chloride 6H 20

    0,051 g

    C 3H 50 3ˉ

    40

    Water for Injections

    Osmolarity

    284mOsm/l

    Hydrochloric acid or sodium hydroxide (for pH adjustment)

    pH

    5,0 – 6,0

    For intraperitoneal use
    Not for intravenous use
    Use as directed by a physician
    Read the package leaflet before use
    Keep out of the sight and reach of children
    Nonpyrogenic
    Do not store below 4°C
    Do not use unless solution is clear and container undamaged
    For single use only
    Once removed from the overpouch use immediately
    Discard unused solution

    UK:
    Baxter Healthcare Ltd
    Caxton Way, Thetford, Norfolk, IP24 3SE,
    United Kingdom

    IE and MT:
    Baxter Holding B.V.,
    Kobaltweg 49, 3542CE, Utrecht,
    Netherlands

    PL 00116/0266
    PA 2299/017/001
    MA 1277/01101

    POM Symbol

    Manufactured by Baxter Healthcare S A IRL-Castlebar CB-35-04-606

    Representative Extraneal Carton Label

    EXTRANEAL
    FPB4945R
    2500 ml x 4

    Solution for Peritoneal Dialysis

    1000 ml

    Icodextrin

    75 g

    Sodium Chloride

    5,4 g

    Sodium (S)-lactate

    4,5 g

    Calcium Chloride 2H 20

    0,257 g

    Magnesium Chloride 6H 20

    0,051 g

    Water for injections to 1000 ml

    Sodium hydroxide or hydrochloric acid (for pH adjustment)

    For intraperitoneal use
    Not for intravenous infusion
    Keep out of the sight and reach of children

    UK: Baxter Healthcare Limited Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom
    IE and MT: Baxter Holding B.V. Kobaltweg 49, 3542CE, Utrecht, Netherlands

    88-46-13-194

    Lot: EXP

    Do not store below 4°C

    Single bag with Luer connector

    MA 1277/01101
    PA 2299/017/001
    PL 00116/0266

    POM Symbol

    Barcode
    (01)50085412574368(17)201200(10)88C88C88B2

    EXTRANEAL
    FPB4945R
    2500 ml x 4

    Lot: EXP

    Vantive Representative Extraneal Container Label

    Lot EXP
    B4945R 2500 ml
    Vantive
    EXTRANEAL Solution for Peritoneal Dialysis

    Formula 1000 ml

    mmol/l

    Icodextrin

    75 g

    Na+

    133

    Sodium Chloride

    5,4 g

    Ca++

    1,75

    Sodium (S)-lactate

    4,5 g

    Mg++

    0,25

    Calcium Chloride 2H 20

    0,257 g

    Clˉ

    96

    Magnesium Chloride 6H 20

    0,051 g

    C 3H 50 3ˉ

    40

    Water for Injections

    Osmolarity

    284mOsm/l

    Hydrochloric acid or sodium hydroxide (for pH adjustment)

    pH

    5,0 – 6,0

    For intraperitoneal use
    Not for intravenous use
    Use as directed by a physician
    Read the package leaflet before use
    Keep out of the sight and reach of children
    Nonpyrogenic
    Do not store below 4°C
    Do not use unless solution is clear and container undamaged
    For single use only
    Once removed from the overpouch use immediately
    Discard unused solution

    Vantive Limited
    Wavertree Technology Park
    2 Wavertree Boulevard
    Liverpool, L7 9PE
    United Kingdom

    PL 58711/0005

    POM Symbol

    CB-35-05-249

    Vantive Representative Extraneal Carton Label

    EXTRANEAL
    FPB4945R
    2500 ml x 4

    Solution for Peritoneal Dialysis

    1000 ml

    Icodextrin

    75 g

    Sodium Chloride

    5,4 g

    Sodium (S)-lactate

    4,5 g

    Calcium Chloride 2H 20

    0,257 g

    Magnesium Chloride 6H 20

    0,051 g

    Water for injections to 1000 ml

    Sodium hydroxide or hydrochloric acid (for pH adjustment)

    For intraperitoneal use
    Not for intravenous infusion
    Keep out of the sight and reach of children

    Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom

    88-46-14-005

    Lot: EXP

    UK Only

    Do not store below 4°C

    Single bag with Luer connector

    PL 58711/0005

    POM Symbol

    Barcode
    (01)57332414203240(17)201200(10)88C88C88B2

    EXTRANEAL
    FPB4945R
    2500 ml x 4

    Lot: EXP

  • INGREDIENTS AND APPEARANCE
    EXTRANEAL 
    icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0941-0681
    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 CHLORIDE540 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT) SODIUM LACTATE450 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 CHLORIDE5.1 mg  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0941-0681-084 in 1 CARTON10/21/202401/31/2027
    1NDC:0941-0681-022500 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 shortage10/21/202401/31/2027
    EXTRANEAL 
    icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0941-0719
    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 CHLORIDE540 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT) SODIUM LACTATE450 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 CHLORIDE5.1 mg  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0941-0719-055 in 1 CARTON10/21/202408/31/2026
    1NDC:0941-0719-012000 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 shortage10/21/202408/31/2026
    Labeler - Vantive US Healthcare LLC (119181963)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare S.A.988899845analysis(0941-0681, 0941-0719) , label(0941-0681, 0941-0719) , manufacture(0941-0681, 0941-0719) , pack(0941-0681, 0941-0719) , sterilize(0941-0681, 0941-0719) , api manufacture(0941-0681, 0941-0719)
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