CLINIMIX (ISOLEUCINE, LEUCINE, VALINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, ARGININE, HISTIDINE, ALANINE, GLYCINE, PROLINE, SERINE, TYROSINE, SODIUM ACETATE, DIBASIC POTA

CLINIMIX (ISOLEUCINE, LEUCINE, VALINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, ARGININE, HISTIDINE, ALANINE, GLYCINE, PROLINE, SERINE, TYROSINE, SODIUM ACETATE, DIBASIC POTA
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NDC 0338-9566-08, 0338-9570-08, 0338-9587-04
Set ID ae826725-59da-491a-9955-319cd0dae116
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Baxter Healthcare Corporation
Generic Name
Product Class Amino Acid
Product Number
Application Number
  • HEALTH CARE PROVIDER LETTER

    DHCP 1
    DHCP 2
    DHCP 3
    DHCP 4
    DHCP 5
    DHCP 6
    DHCP 7
    DHCP 8
    DHCP 9
    DHCP 10
    DHCP 11
    DHCP 12
    DHCP 13
    DHCP 14
    DHCP 15
    DHCP 16
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Clinimix FKB6670C Representative Container Label 1 of 2
    Clinimix FKB6670C Representative Container Label 2 of 2

    Container Label

    Code B6670C 2 x 500 ml
    Baxter Logo
    Clintec Logo Clinimix® N9G20E
    - solution for infusion

    5.5% Amino Acids
    with Electrolytes (500 ml)
    and Glucose 20%
    with Calcium (500 ml)

    Vertical Peel Seal Design
    Characteristics of the mixture (1 litre):

    Nitrogen 4.6 g
    Total calories 510 kcal
    Glucose calories 400 kcal
    Osmolarity 980 mOsm/1
    pH 6.0

    Amino Acids (5.5%)
    with electrolytes

    Volume 500 ml
    Amino acids 28 g
    Glucose anhyd. -
    Nitrogen 4.6 g
    Glucose calories -
    Sodium 35 mmol
    Potassium 30 mmol
    Magnesium 2.5 mmol
    Calcium -
    Chloride 35 mmol
    Phosphate 15 mmol
    Acetate 50 mmol

    Glucose (20%)
    with calcium

    Volume 500 ml
    Amino acids -
    Glucose anhyd. 100 g
    Nitrogen -
    Glucose calories 400 kcal
    Sodium -
    Potassium -
    Magnesium -
    Calcium 2.3 mmol
    Chloride 4.5 mmol
    Phosphate -
    Acetate -

    Final Mixture

    Volume 1000 ml
    Amino acids 28 g
    Glucose anhyd. 100 g
    Nitrogen 4.6 g
    Glucose calories 400 kcal
    Sodium 35 mmol
    Potassium 30 mmol
    Magnesium 2.5 mmol
    Calcium 2.3 mmol
    Chloride 40 mmol
    Phosphate 15 mmol
    Acetate 50 mmol

    Other ingredients:
    Amino acids solution: Acetic acid, Water for injections
    Glucose solution: Hydrochloric acid, Water for injections

    Lot

    Concentration of amino acids after mixing
    (1 litre):
    Essential amino acids

    L-Leucine 2.01 g L-Valine 1.60 g
    L-Phenylalanine 1.54 g L-Histidine 1.32 g
    L-Methionine 1.10 g L-Threonine 1.16 g
    L-Lysine HCI 2.00 g L-Tryptophan 0.50 g
    L-Isoleucine 1.65 g

    Non-essenlial amino acids

    L-Alanine 5.70 g L-Proline 1.87 g
    L-Arginine 3.17 g L-Serine 1.38 g
    Glycine 2.84 g L-Tyrosine 0.11 g

    For intravenous administration.
    Sterile, non pyrogenic solutions.
    Store in outer carton. Do not freeze.
    Do not use unless solution is clear, peel seal is
    intact and container is undamaged.
    Do not connect in series.
    Do not administer before or after administration of
    blood through the same infusion equipment.

    Warning: This solution is hypertonic and can cause
    venous irritation.
    Administer only after breaking the seal and mixing
    the contents of both compartments.
    The binary mixture is stable for 7 days at 2 to 8°C
    followed by 48 hours below 25°C.
    Following additions, the admixture should not be
    kept for more than 24 hours at 2 to 8°C.
    Refer to leaflet.
    Additives may be incompatible.
    Keep all medicines out of reach of children.
    Do not reconnect partially used bag.

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

    88-25-44-604

    Expiry date

    1600

    1000

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    Clinimix FKB6669C Representative Container Label 1 of 2
    Clinimix FKB6669C Representative Container Label 2 of 2

    Container Label

    Code B6669C
    2 x 500 ml

    Baxter Logo

    CLINIMIX® N9G15E
    Solution for infusion

    Clintec Logo

    5.5% Amino Acids
    with Electrolytes (500 ml)
    and Glucose 15%
    with Calcium (500 ml)

    Vertical Peel Seal Design
    Characteristics of the mixture (1 litre):
    Nitrogen 4.6 g
    Total calories 410 kcal
    Glucose calories 300 kcal
    Osmolarity 845 mOsm/l
    pH 6.0

     
    Amino Acids (5.5%)
    with electrolytes

    Volume 500 ml
    Amino acids 28 g
    Glucose anhyd. -
    Nitrogen 4.6 g
    Glucose calories -
    Sodium 35 mmol
    Potassium 30 mmol
    Magnesium 2.5 mmol
    Calcium -
    Chloride 35 mmol
    Phosphate 15 mmol
    Acetate 50 mmol

    Glucose (15%)
    with calcium

    Volume 500 ml
    Amino acids -
    Glucose anhyd. 75 g
    Nitrogen -
    Glucose calories 300 kcal
    Sodium -
    Potassium -
    Magnesium -
    Calcium 2.3 mmol
    Chloride 4.5 mmol
    Phosphate -
    Acetate -

    Final Mixture

     
    Volume 1000 ml
    Amino acids 28 g
    Glucose anhyd. 75 g
    Nitrogen 4.6 g
    Glucose calories 300 kcal
    Sodium 35 mmol
    Potassium 30 mmol
    Magnesium 2.5 mmol
    Calcium 2.3 mmol
    Chloride 40 mmol
    Phosphate 15 mmol
    Acetate 50 mmol

    Other ingredients:
    Amino acids solution: Acetic acid, Water for injections
    Glucose solution: Hydrochloric acid, Water for injections

    Lot

    Concentration of amino acids after mixing (1 litre):
    Essential amino acids

     
    L-Leucine 2.01 g L-Valine 1.60 g
    L-Phenylalanine 1.54 g L-Histidine 1.32 g
    L-Methionine 1.10 g L-Threonine 1.16 g
    L-Lysine HCl 2.00 g L-Tryptophan 0.50 g
    L-Isoleucine 1.65 g

    Non-essential amino acids

    L-Alanine 5.70 g L-Proline 1.87 g
    L-Arginine 3.17 g L-Serine 1.38 g
    Glycine 2.84 g L-Tyrosine 0.11 g

    For intravenous administration.
    Sterile, non pyrogenic solutions.
    Store in outer carton. Do not freeze.
    Do not use unless solution is clear, peel seal is
    intact and container is undamaged.
    Do not connect in series.
    Do not administer before or after administration of
    blood through the same infusion equipment.

    Warning: This solution is hypertonic
    and can cause venous irritation.
    Administer only after breaking the seal and mixing
    the contents of both compartments.
    The binary mixture is stable for 7 days at 2 to 8°C
    followed by 48 hours below 25°C.
    Following additions, the admixture should not be
    kept for more than 24 hours at 2 to 8°C.
    Refer to leaflet.
    Additives may be incompatible.
    Keep all medicines out of reach of children.
    Do not reconnect partially used bag.

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

    TH-35-01-978

    EXP

    1600

    1000

    800

    600

    400

    200

    Clinimix FKB6654V Representative Container Label 1 of 2
    Clinimix FKB6654V Representative Container Label 2 of 2

    Container Label

    Code FKB6654V 2000 ml
    Baxter Logo
    CLINIMIX N14G30E
    Solution for infusion

    With Electrolytes

    Formula for 2000 ml after mixing:
    L-alanine 17.60 g
    L-arginine 9.78 g
    Glycine 8.76 g
    L-histidine 4.08 g
    L-isoleucine 5.10 g
    L-leucine 6.20 g
    L-lysine 4.93 g
    (as lysine hydrochloride) (6.16 g)
    L-methionine 3.40 g
    L-phenylalanine 4.76 g
    L-proline 5.78 g
    L-serine 4.25 g
    L-threonine 3.57 g
    L-tryptophan 1.53 g
    L-tyrosine 0.34 g
    L-valine 4.93 g

    Sodium acetate 3H2O 5.94 g
    Dibasic potassium phosphate 5.22 g
    Sodium chloride 1.54 g
    Magnesium chloride 6H2O 1.02 g
    Glucose anhydrous (as monohydrate) 300 g
    Calcium chloride 2H2O 0.66 g

    Acetic acid, hydrochloric acid, water for injections

    2000 ml of final mixture provides the following:
    Amino acids 85 g
    Nitrogen 14.0 g
    Glucose 300 g
    Total calories 1540 kcal
    Glucose calories 1200 kcal
    Na+ 70 mmol
    K+ 60 mmol
    Mg++ 5.0 mmol
    Ca++ 4.5 mmol
    Acetate 140 mmol
    Chloride 80 mmol
    Phosphate 30 mmol
    pH 6
    Osmolarity 1415 mOsm/l

    8.5% Amino Acids with
    Electrolytes (1000 ml) and
    Glucose 30% with Calcium
    (1000 ml)

    WARNING: Do not infuse
    without opening the seal and
    mixing the contents of the
    two compartments

    Read the package leaflet before use
    Keep out of the reach and sight of children

    For intravenous administration

    Do not freeze
    Store in the outer packaging in order to
    protect from light
    Do not use unless solution is clear and
    container undamaged
    For single use
    Do not store partly used bags and discard
    all equipment after use
    Do not administer before or after
    administration of blood through the same
    infusion equipment
    Additives may be incompatible
    Check compatibility before use
    Do not connect in series

    From a microbiological point of view, it is
    recommended that the product be used
    immediately after mixing However, the
    chemical and physical stability of the mixed
    solution has been demonstrated for 7 days
    (between 2°C and 8°C) followed by
    48 hours at temperature not exceeding
    25°C If not used immediately, the in
    use storage time and conditions are the
    responsibility of the user

    PL 00116/0300
    PA 167/98/4

    Baxter Healthcare Limited
    Caxton Way
    Thetford
    Norfolk
    IP24 3SE
    United Kingdom

    POM Symbol

    CLINIMIX N14G30E
    Solution for infusion 2000 ml

    TH-35-01-780

    EXP

    2600

    2000

    1600

    1000

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  • INGREDIENTS AND APPEARANCE
    CLINIMIX 
    isoleucine, leucine, valine, lysine, methionine, phenylalanine, threonine, tryptophan, arginine, histidine, alanine, glycine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, sodium chloride, magnesium chloride, dextrose monohydrate, calcium chloride solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9566
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE1.65 g  in 1 L
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE2.01 g  in 1 L
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE1.60 g  in 1 L
    LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE2.00 g  in 1 L
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE1.10 g  in 1 L
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE1.54 g  in 1 L
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE1.16 g  in 1 L
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN0.50 g  in 1 L
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE3.17 g  in 1 L
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE1.32 g  in 1 L
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE5.70 g  in 1 L
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE2.84 g  in 1 L
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE1.87 g  in 1 L
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE1.38 g  in 1 L
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE0.11 g  in 1 L
    SODIUM ACETATE (UNII: 4550K0SC9B) (SODIUM CATION - UNII:LYR4M0NH37, ACETATE ION - UNII:569DQM74SC) SODIUM ACETATE2.16 g  in 1 L
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR, POTASSIUM CATION - UNII:295O53K152) POTASSIUM PHOSPHATE, DIBASIC2.61 g  in 1 L
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE1.12 g  in 1 L
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE0.51 g  in 1 L
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE100.00 g  in 1 L
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE0.33 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-9566-088 in 1 CARTON10/25/201710/02/2019
    11 L 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 shortage10/25/201711/30/2019
    CLINIMIX 
    isoleucine, leucine, valine, lysine, methionine, phenylalanine, threonine, tryptophan, arginine, histidine, alanine, glycine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, sodium chloride, magnesium chloride, dextrose monohydrate, calcium chloride solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9570
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE1.65 g  in 1 L
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE2.01 g  in 1 L
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE1.60 g  in 1 L
    LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE2.00 g  in 1 L
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE1.10 g  in 1 L
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE1.54 g  in 1 L
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE1.16 g  in 1 L
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN0.50 g  in 1 L
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE3.17 g  in 1 L
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE1.32 g  in 1 L
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE5.70 g  in 1 L
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE2.84 g  in 1 L
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE1.87 g  in 1 L
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE1.38 g  in 1 L
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE0.11 g  in 1 L
    SODIUM ACETATE (UNII: 4550K0SC9B) (SODIUM CATION - UNII:LYR4M0NH37, ACETATE ION - UNII:569DQM74SC) SODIUM ACETATE2.16 g  in 1 L
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR, POTASSIUM CATION - UNII:295O53K152) POTASSIUM PHOSPHATE, DIBASIC2.61 g  in 1 L
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE1.12 g  in 1 L
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE0.51 g  in 1 L
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE75.00 g  in 1 L
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE0.33 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-9570-088 in 1 CARTON10/25/201709/30/2019
    11 L 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 shortage10/25/201711/30/2019
    CLINIMIX 
    isoleucine, leucine, valine, lysine, methionine, phenylalanine, threonine, tryptophan, arginine, histidine, alanine, glycine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, sodium chloride, magnesium chloride, dextrose monohydrate, calcium chloride solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9587
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE5.10 g  in 2 L
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE6.20 g  in 2 L
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE4.93 g  in 2 L
    LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE4.93 g  in 2 L
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE3.40 g  in 2 L
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE4.76 g  in 2 L
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE3.57 g  in 2 L
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN1.53 g  in 2 L
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE9.78 g  in 2 L
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE4.08 g  in 2 L
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE17.60 g  in 2 L
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE8.76 g  in 2 L
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE5.78 g  in 2 L
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE4.25 g  in 2 L
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE0.34 g  in 2 L
    SODIUM ACETATE (UNII: 4550K0SC9B) (SODIUM CATION - UNII:LYR4M0NH37, ACETATE ION - UNII:569DQM74SC) SODIUM ACETATE5.94 g  in 2 L
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR, POTASSIUM CATION - UNII:295O53K152) POTASSIUM PHOSPHATE, DIBASIC5.22 g  in 2 L
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE1.54 g  in 2 L
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE1.02 g  in 2 L
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE300.00 g  in 2 L
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE0.66 g  in 2 L
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-9587-044 in 1 CARTON10/25/201711/30/2019
    12 L 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 shortage10/25/201711/30/2019
    Labeler - Baxter Healthcare Corporation (005083209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare Ltd221478644ANALYSIS(0338-9566, 0338-9570, 0338-9587) , LABEL(0338-9566, 0338-9570, 0338-9587) , MANUFACTURE(0338-9566, 0338-9570, 0338-9587) , PACK(0338-9566, 0338-9570, 0338-9587) , STERILIZE(0338-9566, 0338-9570, 0338-9587)