PRISMASOL BGK4/0/1.2

Basic Information

Product Name

FDA Product Code

24571-114

Regulatory Information

NDC Product Code

24571-114

Application Number

NDA021703

Marketing Category

C73594

Effective Date

November 1, 2018

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

WATER

Code: 059QF0KO0R

Class Code: IACT

CARBON DIOXIDE

Code: 142M471B3J

Class Code: IACT

MAGNESIUM CHLORIDE

Quantity: 2.44 g in 1 L

Code: 02F3473H9O

Class Code: ACTIB

DEXTROSE MONOHYDRATE

Quantity: 22 g in 1 L

Code: LX22YL083G

Class Code: ACTIB

SODIUM CHLORIDE

Quantity: 6.46 g in 1 L

Code: 451W47IQ8X

Class Code: ACTIB

SODIUM BICARBONATE

Quantity: 3.09 g in 1 L

Code: 8MDF5V39QO

Class Code: ACTIB

POTASSIUM CHLORIDE

Quantity: 0.314 g in 1 L

Code: 660YQ98I10

Class Code: ACTIB

LACTIC ACID, UNSPECIFIED FORM

Quantity: 5.4 g in 1 L

Code: 33X04XA5AT

Class Code: ACTIB

Active Moieties

CHLORIDE ION

Code: Q32ZN48698

ANHYDROUS DEXTROSE

Code: 5SL0G7R0OK

BICARBONATE ION

Code: HN1ZRA3Q20

LACTIC ACID, UNSPECIFIED FORM

Code: 33X04XA5AT

Basic Information

Regulatory Information

Company Information

Active Ingredients

WATER

CARBON DIOXIDE

Active Moieties

CHLORIDE ION

ANHYDROUS DEXTROSE

BICARBONATE ION

LACTIC ACID, UNSPECIFIED FORM