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PRISMASOL

These highlights do not include all the information needed to use PRISMASOL and PHOXILLUM safely and effectively. See full prescribing information for PRISMASOL and PHOXILLUM. PRISMASOL renal replacement solutionPRISMASOL Initial U.S. Approval: 2006 PHOXILLUM renal replacement solutionPHOXILLUM Initial U.S. Approval: 2015

Approved
Approval ID

7f675fee-8940-4ece-bb0c-75ac79d8708c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 2, 2023

Manufacturers
FDA

Baxter Healthcare Corporation

DUNS: 005083209

Products 9

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code24571-117
Application NumberNDA207026
Product Classification
M
Marketing Category
C73594
G
Generic Name
magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 1, 2018
FDA Product Classification

INGREDIENTS (8)

MAGNESIUM CHLORIDEActive
Quantity: 3.05 g in 1 L
Code: 02F3473H9O
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 6.95 g in 1 L
Code: 451W47IQ8X
Classification: ACTIB
SODIUM BICARBONATEActive
Quantity: 2.21 g in 1 L
Code: 8MDF5V39QO
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 0.314 g in 1 L
Code: 660YQ98I10
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARBON DIOXIDEInactive
Code: 142M471B3J
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEActive
Quantity: 0.187 g in 1 L
Code: 94255I6E2T
Classification: ACTIB

calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code24571-103
Application NumberNDA021703
Product Classification
M
Marketing Category
C73594
G
Generic Name
calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 1, 2018
FDA Product Classification

INGREDIENTS (9)

CALCIUM CHLORIDEActive
Quantity: 5.15 g in 1 L
Code: M4I0D6VV5M
Classification: ACTIB
SODIUM BICARBONATEActive
Quantity: 3.09 g in 1 L
Code: 8MDF5V39QO
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MAGNESIUM CHLORIDEActive
Quantity: 2.03 g in 1 L
Code: 02F3473H9O
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 6.46 g in 1 L
Code: 451W47IQ8X
Classification: ACTIB
DEXTROSE MONOHYDRATEActive
Quantity: 22 g in 1 L
Code: LX22YL083G
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 0.157 g in 1 L
Code: 660YQ98I10
Classification: ACTIB
CARBON DIOXIDEInactive
Code: 142M471B3J
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMActive
Quantity: 5.4 g in 1 L
Code: 33X04XA5AT
Classification: ACTIB

magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code24571-111
Application NumberNDA021703
Product Classification
M
Marketing Category
C73594
G
Generic Name
magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 1, 2018
FDA Product Classification

INGREDIENTS (8)

MAGNESIUM CHLORIDEActive
Quantity: 3.05 g in 1 L
Code: 02F3473H9O
Classification: ACTIB
DEXTROSE MONOHYDRATEActive
Quantity: 22 g in 1 L
Code: LX22YL083G
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 7.07 g in 1 L
Code: 451W47IQ8X
Classification: ACTIB
SODIUM BICARBONATEActive
Quantity: 2.21 g in 1 L
Code: 8MDF5V39QO
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 0.314 g in 1 L
Code: 660YQ98I10
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARBON DIOXIDEInactive
Code: 142M471B3J
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMActive
Quantity: 5.4 g in 1 L
Code: 33X04XA5AT
Classification: ACTIB

calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code24571-105
Application NumberNDA021703
Product Classification
M
Marketing Category
C73594
G
Generic Name
calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 1, 2018
FDA Product Classification

INGREDIENTS (9)

POTASSIUM CHLORIDEActive
Quantity: 0.314 g in 1 L
Code: 660YQ98I10
Classification: ACTIB
CALCIUM CHLORIDEActive
Quantity: 3.68 g in 1 L
Code: M4I0D6VV5M
Classification: ACTIB
MAGNESIUM CHLORIDEActive
Quantity: 3.05 g in 1 L
Code: 02F3473H9O
Classification: ACTIB
DEXTROSE MONOHYDRATEActive
Quantity: 22 g in 1 L
Code: LX22YL083G
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 6.46 g in 1 L
Code: 451W47IQ8X
Classification: ACTIB
SODIUM BICARBONATEActive
Quantity: 3.09 g in 1 L
Code: 8MDF5V39QO
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARBON DIOXIDEInactive
Code: 142M471B3J
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMActive
Quantity: 5.4 g in 1 L
Code: 33X04XA5AT
Classification: ACTIB

calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride and sodium bicarbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code24571-108
Application NumberNDA021703
Product Classification
M
Marketing Category
C73594
G
Generic Name
calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride and sodium bicarbonate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 1, 2018
FDA Product Classification

INGREDIENTS (8)

CALCIUM CHLORIDEActive
Quantity: 3.68 g in 1 L
Code: M4I0D6VV5M
Classification: ACTIB
MAGNESIUM CHLORIDEActive
Quantity: 3.05 g in 1 L
Code: 02F3473H9O
Classification: ACTIB
DEXTROSE MONOHYDRATEActive
Quantity: 22 g in 1 L
Code: LX22YL083G
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 6.46 g in 1 L
Code: 451W47IQ8X
Classification: ACTIB
SODIUM BICARBONATEActive
Quantity: 3.09 g in 1 L
Code: 8MDF5V39QO
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARBON DIOXIDEInactive
Code: 142M471B3J
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMActive
Quantity: 5.4 g in 1 L
Code: 33X04XA5AT
Classification: ACTIB

magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code24571-114
Application NumberNDA021703
Product Classification
M
Marketing Category
C73594
G
Generic Name
magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 1, 2018
FDA Product Classification

INGREDIENTS (8)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARBON DIOXIDEInactive
Code: 142M471B3J
Classification: IACT
MAGNESIUM CHLORIDEActive
Quantity: 2.44 g in 1 L
Code: 02F3473H9O
Classification: ACTIB
DEXTROSE MONOHYDRATEActive
Quantity: 22 g in 1 L
Code: LX22YL083G
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 6.46 g in 1 L
Code: 451W47IQ8X
Classification: ACTIB
SODIUM BICARBONATEActive
Quantity: 3.09 g in 1 L
Code: 8MDF5V39QO
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 0.314 g in 1 L
Code: 660YQ98I10
Classification: ACTIB
LACTIC ACID, UNSPECIFIED FORMActive
Quantity: 5.4 g in 1 L
Code: 33X04XA5AT
Classification: ACTIB

magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code24571-102
Application NumberNDA021703
Product Classification
M
Marketing Category
C73594
G
Generic Name
magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 1, 2018
FDA Product Classification

INGREDIENTS (8)

DEXTROSE MONOHYDRATEActive
Quantity: 22 g in 1 L
Code: LX22YL083G
Classification: ACTIB
MAGNESIUM CHLORIDEActive
Quantity: 2.03 g in 1 L
Code: 02F3473H9O
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 6.46 g in 1 L
Code: 451W47IQ8X
Classification: ACTIB
SODIUM BICARBONATEActive
Quantity: 3.09 g in 1 L
Code: 8MDF5V39QO
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 0.157 g in 1 L
Code: 660YQ98I10
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARBON DIOXIDEInactive
Code: 142M471B3J
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMActive
Quantity: 5.4 g in 1 L
Code: 33X04XA5AT
Classification: ACTIB

magnesium chloride, lactic acid, sodium chloride and sodium bicarbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code24571-113
Application NumberNDA021703
Product Classification
M
Marketing Category
C73594
G
Generic Name
magnesium chloride, lactic acid, sodium chloride and sodium bicarbonate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 1, 2018
FDA Product Classification

INGREDIENTS (6)

MAGNESIUM CHLORIDEActive
Quantity: 2.44 g in 1 L
Code: 02F3473H9O
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 6.46 g in 1 L
Code: 451W47IQ8X
Classification: ACTIB
SODIUM BICARBONATEActive
Quantity: 3.09 g in 1 L
Code: 8MDF5V39QO
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARBON DIOXIDEInactive
Code: 142M471B3J
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMActive
Quantity: 5.4 g in 1 L
Code: 33X04XA5AT
Classification: ACTIB

calcium chloride, magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code24571-116
Application NumberNDA207026
Product Classification
M
Marketing Category
C73594
G
Generic Name
calcium chloride, magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 1, 2018
FDA Product Classification

INGREDIENTS (9)

CALCIUM CHLORIDEActive
Quantity: 3.68 g in 1 L
Code: M4I0D6VV5M
Classification: ACTIB
MAGNESIUM CHLORIDEActive
Quantity: 3.05 g in 1 L
Code: 02F3473H9O
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 6.34 g in 1 L
Code: 451W47IQ8X
Classification: ACTIB
SODIUM BICARBONATEActive
Quantity: 3.09 g in 1 L
Code: 8MDF5V39QO
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 0.314 g in 1 L
Code: 660YQ98I10
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARBON DIOXIDEInactive
Code: 142M471B3J
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEActive
Quantity: 0.187 g in 1 L
Code: 94255I6E2T
Classification: ACTIB

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