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FDA Approval

PRISMASOL

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Baxter Healthcare Corporation
DUNS: 005083209
Effective Date
May 2, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Magnesium chloride(3.05 g in 1 L)
Sodium chloride(6.95 g in 1 L)
Sodium bicarbonate(2.21 g in 1 L)
Potassium chloride(0.314 g in 1 L)
Potassium phosphate, dibasic, trihydrate(0.187 g in 1 L)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Baxter Healthcare Corporation

005083209

Manufacturing Establishments2

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Baxter, S.A. de C.V.

Baxter Healthcare Corporation

Baxter Healthcare Corporation

810432484

Bieffe Medital S.p.A.

Baxter Healthcare Corporation

Baxter Healthcare Corporation

437668413

Products9

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

PHOXILLUM B22K4/0

Product Details

NDC Product Code
24571-117
Application Number
NDA207026
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
November 1, 2018
Magnesium chlorideActive
Code: 02F3473H9OClass: ACTIBQuantity: 3.05 g in 1 L
Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 6.95 g in 1 L
Sodium bicarbonateActive
Code: 8MDF5V39QOClass: ACTIBQuantity: 2.21 g in 1 L
Potassium chlorideActive
Code: 660YQ98I10Class: ACTIBQuantity: 0.314 g in 1 L
WATERInactive
Code: 059QF0KO0RClass: IACT
CARBON DIOXIDEInactive
Code: 142M471B3JClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
Potassium phosphate, dibasic, trihydrateActive
Code: 94255I6E2TClass: ACTIBQuantity: 0.187 g in 1 L

PRISMASOL BGK2/3.5

Product Details

NDC Product Code
24571-103
Application Number
NDA021703
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
November 1, 2018
Calcium chlorideActive
Code: M4I0D6VV5MClass: ACTIBQuantity: 5.15 g in 1 L
Sodium bicarbonateActive
Code: 8MDF5V39QOClass: ACTIBQuantity: 3.09 g in 1 L
WATERInactive
Code: 059QF0KO0RClass: IACT
Magnesium chlorideActive
Code: 02F3473H9OClass: ACTIBQuantity: 2.03 g in 1 L
Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 6.46 g in 1 L
GlucoseActive
Code: LX22YL083GClass: ACTIBQuantity: 22 g in 1 L
Potassium chlorideActive
Code: 660YQ98I10Class: ACTIBQuantity: 0.157 g in 1 L
CARBON DIOXIDEInactive
Code: 142M471B3JClass: IACT
Lactic acid/carbamideActive
Code: 33X04XA5ATClass: ACTIBQuantity: 5.4 g in 1 L

PRISMASOL B22GK4/0

Product Details

NDC Product Code
24571-111
Application Number
NDA021703
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
November 1, 2018
Magnesium chlorideActive
Code: 02F3473H9OClass: ACTIBQuantity: 3.05 g in 1 L
GlucoseActive
Code: LX22YL083GClass: ACTIBQuantity: 22 g in 1 L
Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 7.07 g in 1 L
Sodium bicarbonateActive
Code: 8MDF5V39QOClass: ACTIBQuantity: 2.21 g in 1 L
Potassium chlorideActive
Code: 660YQ98I10Class: ACTIBQuantity: 0.314 g in 1 L
WATERInactive
Code: 059QF0KO0RClass: IACT
CARBON DIOXIDEInactive
Code: 142M471B3JClass: IACT
Lactic acid/carbamideActive
Code: 33X04XA5ATClass: ACTIBQuantity: 5.4 g in 1 L

PRISMASOL BGK4/2.5

Product Details

NDC Product Code
24571-105
Application Number
NDA021703
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
November 1, 2018
Potassium chlorideActive
Code: 660YQ98I10Class: ACTIBQuantity: 0.314 g in 1 L
Calcium chlorideActive
Code: M4I0D6VV5MClass: ACTIBQuantity: 3.68 g in 1 L
Magnesium chlorideActive
Code: 02F3473H9OClass: ACTIBQuantity: 3.05 g in 1 L
GlucoseActive
Code: LX22YL083GClass: ACTIBQuantity: 22 g in 1 L
Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 6.46 g in 1 L
Sodium bicarbonateActive
Code: 8MDF5V39QOClass: ACTIBQuantity: 3.09 g in 1 L
WATERInactive
Code: 059QF0KO0RClass: IACT
CARBON DIOXIDEInactive
Code: 142M471B3JClass: IACT
Lactic acid/carbamideActive
Code: 33X04XA5ATClass: ACTIBQuantity: 5.4 g in 1 L

PRISMASOL BGK0/2.5

Product Details

NDC Product Code
24571-108
Application Number
NDA021703
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
November 1, 2018
Calcium chlorideActive
Code: M4I0D6VV5MClass: ACTIBQuantity: 3.68 g in 1 L
Magnesium chlorideActive
Code: 02F3473H9OClass: ACTIBQuantity: 3.05 g in 1 L
GlucoseActive
Code: LX22YL083GClass: ACTIBQuantity: 22 g in 1 L
Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 6.46 g in 1 L
Sodium bicarbonateActive
Code: 8MDF5V39QOClass: ACTIBQuantity: 3.09 g in 1 L
WATERInactive
Code: 059QF0KO0RClass: IACT
CARBON DIOXIDEInactive
Code: 142M471B3JClass: IACT
Lactic acid/carbamideActive
Code: 33X04XA5ATClass: ACTIBQuantity: 5.4 g in 1 L

PRISMASOL BGK4/0/1.2

Product Details

NDC Product Code
24571-114
Application Number
NDA021703
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
November 1, 2018
WATERInactive
Code: 059QF0KO0RClass: IACT
CARBON DIOXIDEInactive
Code: 142M471B3JClass: IACT
Magnesium chlorideActive
Code: 02F3473H9OClass: ACTIBQuantity: 2.44 g in 1 L
GlucoseActive
Code: LX22YL083GClass: ACTIBQuantity: 22 g in 1 L
Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 6.46 g in 1 L
Sodium bicarbonateActive
Code: 8MDF5V39QOClass: ACTIBQuantity: 3.09 g in 1 L
Potassium chlorideActive
Code: 660YQ98I10Class: ACTIBQuantity: 0.314 g in 1 L
Lactic acid/carbamideActive
Code: 33X04XA5ATClass: ACTIBQuantity: 5.4 g in 1 L

PRISMASOL BGK2/0

Product Details

NDC Product Code
24571-102
Application Number
NDA021703
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
November 1, 2018
GlucoseActive
Code: LX22YL083GClass: ACTIBQuantity: 22 g in 1 L
Magnesium chlorideActive
Code: 02F3473H9OClass: ACTIBQuantity: 2.03 g in 1 L
Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 6.46 g in 1 L
Sodium bicarbonateActive
Code: 8MDF5V39QOClass: ACTIBQuantity: 3.09 g in 1 L
Potassium chlorideActive
Code: 660YQ98I10Class: ACTIBQuantity: 0.157 g in 1 L
WATERInactive
Code: 059QF0KO0RClass: IACT
CARBON DIOXIDEInactive
Code: 142M471B3JClass: IACT
Lactic acid/carbamideActive
Code: 33X04XA5ATClass: ACTIBQuantity: 5.4 g in 1 L

PRISMASOL BK0/0/1.2

Product Details

NDC Product Code
24571-113
Application Number
NDA021703
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
November 1, 2018
Magnesium chlorideActive
Code: 02F3473H9OClass: ACTIBQuantity: 2.44 g in 1 L
Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 6.46 g in 1 L
Sodium bicarbonateActive
Code: 8MDF5V39QOClass: ACTIBQuantity: 3.09 g in 1 L
WATERInactive
Code: 059QF0KO0RClass: IACT
CARBON DIOXIDEInactive
Code: 142M471B3JClass: IACT
Lactic acid/carbamideActive
Code: 33X04XA5ATClass: ACTIBQuantity: 5.4 g in 1 L

PHOXILLUM BK4/2.5

Product Details

NDC Product Code
24571-116
Application Number
NDA207026
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
November 1, 2018
Calcium chlorideActive
Code: M4I0D6VV5MClass: ACTIBQuantity: 3.68 g in 1 L
Magnesium chlorideActive
Code: 02F3473H9OClass: ACTIBQuantity: 3.05 g in 1 L
Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 6.34 g in 1 L
Sodium bicarbonateActive
Code: 8MDF5V39QOClass: ACTIBQuantity: 3.09 g in 1 L
Potassium chlorideActive
Code: 660YQ98I10Class: ACTIBQuantity: 0.314 g in 1 L
WATERInactive
Code: 059QF0KO0RClass: IACT
CARBON DIOXIDEInactive
Code: 142M471B3JClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
Potassium phosphate, dibasic, trihydrateActive
Code: 94255I6E2TClass: ACTIBQuantity: 0.187 g in 1 L
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