Normosol-R

Basic Information

Product Name

Normosol-R

FDA Product Code

0990-7670

Regulatory Information

NDC Product Code

0990-7670

Application Number

NDA017586

Marketing Category

C73594

Effective Date

January 6, 2022

Territorial Authority

USA

FDA Title

NORMOSOL-R pH 7.4

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

SODIUM CHLORIDE

Quantity: 526 mg in 100 mL

Code: 451W47IQ8X

Class Code: ACTIB

SODIUM ACETATE ANHYDROUS

Quantity: 222 mg in 100 mL

Code: NVG71ZZ7P0

Class Code: ACTIB

SODIUM GLUCONATE

Quantity: 502 mg in 100 mL

Code: R6Q3791S76

Class Code: ACTIB

POTASSIUM CHLORIDE

Quantity: 37 mg in 100 mL

Code: 660YQ98I10

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

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

Active Moieties

MAGNESIUM CATION

Code: T6V3LHY838

CHLORIDE ION

Code: Q32ZN48698

SODIUM CATION

Code: LYR4M0NH37

POTASSIUM CATION

Code: 295O53K152

Basic Information

Regulatory Information

Company Information

Active Ingredients

WATER

HYDROCHLORIC ACID

SODIUM HYDROXIDE

Active Moieties

MAGNESIUM CATION

CHLORIDE ION

SODIUM CATION

POTASSIUM CATION