PRISMASOL BK0/0/1.2

Basic Information

Product Name

PRISMASOL BK0/0/1.2

FDA Product Code

24571-113

Regulatory Information

NDC Product Code

24571-113

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

MAGNESIUM CHLORIDE

Quantity: 2.44 g in 1 L

Code: 02F3473H9O

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

WATER

Code: 059QF0KO0R

Class Code: IACT

CARBON DIOXIDE

Code: 142M471B3J

Class Code: IACT

LACTIC ACID, UNSPECIFIED FORM

Quantity: 5.4 g in 1 L

Code: 33X04XA5AT

Class Code: ACTIB

Active Moieties

CHLORIDE ION

Code: Q32ZN48698

LACTIC ACID, UNSPECIFIED FORM

Code: 33X04XA5AT

BICARBONATE ION

Code: HN1ZRA3Q20

Basic Information

Regulatory Information

Company Information

Active Ingredients

WATER

CARBON DIOXIDE

Active Moieties

CHLORIDE ION

LACTIC ACID, UNSPECIFIED FORM

BICARBONATE ION