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FDA Approval

Ionosol MB and Dextrose

CompanyICU Medical Inc. (DUNS: 118380146)

Effective Date

March 8, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Glucose(5 g in 100 mL)

Lactic acid(260 mg in 100 mL)

Potassium chloride(141 mg in 100 mL)

Sodium phosphate, dibasic(25 mg in 100 mL)

Magnesium chloride(30 mg in 100 mL)

Monopotassium phosphate(15 mg in 100 mL)

Products (1)

Ionosol MB and Dextrose

NDC Product Code

0990-7372

Application Number

NDA019513

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS

Effective Date

March 8, 2021

Ingredients

Code: LX22YL083GClass: ACTIBQuantity: 5 g in 100 mL

Lactic acidActive

Code: TU7HW0W0QTClass: ACTIBQuantity: 260 mg in 100 mL

Potassium chlorideActive

Code: 660YQ98I10Class: ACTIBQuantity: 141 mg in 100 mL

Sodium phosphate, dibasicActive

Code: 593YOG76RNClass: ACTIBQuantity: 25 mg in 100 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

Magnesium chlorideActive

Code: 02F3473H9OClass: ACTIBQuantity: 30 mg in 100 mL

Monopotassium phosphateActive

Code: 4J9FJ0HL51Class: ACTIBQuantity: 15 mg in 100 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

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