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FDA Product

Normosol-R and Dextrose

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

Basic Information

Normosol-R and Dextrose

0990-7968

Regulatory Information

0990-7968

NDA017609

C73594

November 6, 2020

USA

Normosol-R and 5% Dextrose Injection

HUMAN PRESCRIPTION DRUG LABEL

9

Company Information

ICU Medical Inc.

118380146

Active Ingredients

DEXTROSE, UNSPECIFIED FORM

Quantity: 5 g in 100 mL

Code: IY9XDZ35W2

Class Code: ACTIB

SODIUM CHLORIDE

Quantity: 526 mg in 100 mL

Code: 451W47IQ8X

Class Code: ACTIB

POTASSIUM CHLORIDE

Quantity: 37 mg in 100 mL

Code: 660YQ98I10

Class Code: ACTIB

SODIUM GLUCONATE

Quantity: 502 mg in 100 mL

Code: R6Q3791S76

Class Code: ACTIB

SODIUM ACETATE ANHYDROUS

Quantity: 222 mg in 100 mL

Code: NVG71ZZ7P0

Class Code: ACTIB

MAGNESIUM CHLORIDE

Quantity: 30 mg in 100 mL

Code: 02F3473H9O

Class Code: ACTIB

WATER

Code: 059QF0KO0R

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

Active Moieties

CHLORIDE ION

Code: Q32ZN48698

SODIUM CATION

Code: LYR4M0NH37

DEXTROSE, UNSPECIFIED FORM

Code: IY9XDZ35W2

POTASSIUM CATION

Code: 295O53K152

MAGNESIUM CATION

Code: T6V3LHY838

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