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FDA Product

Isolyte S pH 7.4

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Isolyte S pH 7.4

0264-7707

Regulatory Information

0264-7707

NDA019696

C73594

October 6, 2023

USA

Isolyte S pH 7.4 (Multi-Electrolyte Injection)

HUMAN PRESCRIPTION DRUG LABEL

9

Company Information

002397347

Active Ingredients

SODIUM CHLORIDE

Quantity: 0.53 g in 100 mL

Code: 451W47IQ8X

Class Code: ACTIB

SODIUM ACETATE

Quantity: 0.37 g in 100 mL

Code: 4550K0SC9B

Class Code: ACTIB

POTASSIUM CHLORIDE

Quantity: 0.037 g in 100 mL

Code: 660YQ98I10

Class Code: ACTIB

SODIUM PHOSPHATE, DIBASIC

Quantity: 0.012 g in 100 mL

Code: GR686LBA74

Class Code: ACTIB

WATER

Code: 059QF0KO0R

Class Code: IACT

POTASSIUM PHOSPHATE, MONOBASIC

Quantity: 0.00082 g in 100 mL

Code: 4J9FJ0HL51

Class Code: ACTIB

SODIUM GLUCONATE

Quantity: 0.5 g in 100 mL

Code: R6Q3791S76

Class Code: ACTIB

MAGNESIUM CHLORIDE

Quantity: 0.03 g in 100 mL

Code: 02F3473H9O

Class Code: ACTIB

Active Moieties

CHLORIDE ION

Code: Q32ZN48698

GLUCONIC ACID

Code: R4R8J0Q44B

ACETATE ION

Code: 569DQM74SC

POTASSIUM CATION

Code: 295O53K152

PHOSPHATE ION

Code: NK08V8K8HR

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