Label: HEPARIN SODIUM AND SODIUM CHLORIDE- heparin sodium injection, solution

  • NDC Code(s): 0338-9552-10, 0338-9556-20
  • Packager: Baxter Healthcare Corporation
  • 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 13, 2019

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  • HEALTH CARE PROVIDER LETTER
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Drug Shortage Heparin Representative Container Label 1

    Container Label

    Code B0953G
    500 ml
    Baxter Logo
    Heparin Sodium BP 2000 IU/L in
    0.9% w/v Sodium Chloride IV Infusion

    VIAFLEX container

    Sterile nonpyrogenic
    Solution for Infusion
    Single Dose

    Each 500 ml contains
    Heparin Sodium (Mucous) 1000 IU
    Sodium Chloride 4.5 g
    Disodium Phosphate 12H 2 0 2.9 g
    Citric Acid (Monohydrate) 0.202g
    Water for Injections

    mmol per 500 ml (approx)
    Sodium 93
    Chloride 77
    Phosphate 8
    Citrate 1

    For intravenous administration
    Store out of reach and sight of children
    Do not remove from overwrap until ready for use
    Do not use unless solution is clear and container is
    undamaged
    Do not add any supplementary medication
    For use under medical supervision
    Do not store above 25°C
    Discard any unused portion
    Do not reconnect partially used bags
    Baxter Healthcare Ltd
    Thetford Norfolk IP24 3SE
    PL00116/0130
    POM symbol
    Heparin Sodium BP 2000 IU/L in
    0.9% w/v Sodium Chloride
    IV Infusion

    TH-35-01-749
    Lot
    Expiry
    1
    2
    3
    4

    Drug Shortage Heparin Representative Container Label 2

    Container Label

    Code B0944
    1000 ml
    Baxter Logo
    Heparin Sodium BP 2000 IU/L in
    0.9% w/v Sodium Chloride IV Infusion

    VIAFLEX container
    Sterile nonpyrogenic
    Solution for Infusion
    Single Dose

     
    Each 1000 ml contains
    Heparin Sodium (Mucous) 2000 IU
    Sodium Chloride 9 g
    Disodium Phosphate 12H 2 0 5.8 g
    Citric Acid (Monohydrate) 0.405 g
    Water for Injections

    mmol per 1000 ml (approx)
    Sodium 186
    Chloride 154
    Phosphate 16
    Citrate 2

    For intravenous administration
    Store out of reach and sight of children
    Do not remove from overwrap until ready for
    use
    Do not use unless solution is clear and container
    is undamaged
    Do not add any supplementary medication
    For use under medical supervision
    Do not store above 25°C
    Discard any unused portion
    Do not reconnect partially used bags

    Baxter Healthcare Ltd
    Thetford Norfolk IP24 3SE
    PL00116/0130
    POM symbol
    TH-35-01-237

    Heparin Sodium BP 2000 IU/L in
    0.9% w/v Sodium Chloride
    IV Infusion

    Lot
    Expiry
    1
    2
    3
    4
    5
    6
    7
    8
    9

    Close
  • INGREDIENTS AND APPEARANCE
    HEPARIN SODIUM AND SODIUM CHLORIDE 
    heparin sodium injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-9556
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HEPARIN SODIUM (UNII: ZZ45AB24CA) (HEPARIN - UNII:T2410KM04A) HEPARIN 1000 [iU]  in 500 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 4.5 g  in 500 mL
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) 2.9 g  in 500 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.202 g  in 500 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0338-9556-20 20 in 1 CARTON 10/25/2017
    1 500 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug for use in drug shortage 10/25/2017
    HEPARIN SODIUM AND SODIUM CHLORIDE 
    heparin sodium injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-9552
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HEPARIN SODIUM (UNII: ZZ45AB24CA) (HEPARIN - UNII:T2410KM04A) HEPARIN 2000 [iU]  in 1000 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 9 g  in 1000 mL
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) 5.8 g  in 1000 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.405 g  in 1000 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0338-9552-10 10 in 1 CARTON 10/25/2017
    1 1000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug for use in drug shortage 10/25/2017
    Labeler - Baxter Healthcare Corporation (005083209)
    Establishment
    Name Address ID/FEI Business Operations
    Baxter Healthcare Ltd 221478644 ANALYSIS(0338-9556, 0338-9552) , MANUFACTURE(0338-9556, 0338-9552) , LABEL(0338-9556, 0338-9552) , PACK(0338-9556, 0338-9552) , STERILIZE(0338-9556, 0338-9552)
    Close