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FDA Approval

Lactated Ringers

CompanyBaxter Healthcare Corporation (DUNS: 005083209)

Effective Date

January 2, 2018

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Sodium chloride(6 g in 1000 mL)

Lactic acid(3.1 g in 1000 mL)

Potassium chloride(300 mg in 1000 mL)

Calcium chloride(200 mg in 1000 mL)

Manufacturing Establishments (1)

Baxter Healthcare Corporation

Labeler

Baxter Healthcare Corporation

DUNS Number

194684502

Products (1)

Lactated Ringers

NDC Product Code

0338-0137

Application Number

NDA018921

Marketing Category

NDA (C73594)

Route of Administration

IRRIGATION

Effective Date

September 29, 2015

Ingredients

Sodium chlorideActive

Code: 451W47IQ8XClass: ACTIBQuantity: 6 g in 1000 mL

Lactic acidActive

Code: TU7HW0W0QTClass: ACTIBQuantity: 3.1 g in 1000 mL

Potassium chlorideActive

Code: 660YQ98I10Class: ACTIBQuantity: 300 mg in 1000 mL

Calcium chlorideActive

Code: M4I0D6VV5MClass: ACTIBQuantity: 200 mg in 1000 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

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