NORMOSOL-M AND DEXTROSE

Basic Information

Product Name

FDA Product Code

0990-7965

Regulatory Information

NDC Product Code

0990-7965

Application Number

NDA017610

Marketing Category

C73594

Effective Date

July 13, 2021

Territorial Authority

USA

FDA Title

NORMOSOL™-M and 5% DEXTROSE InjectionMULTIPLE ELECTROLYTES AND 5% DEXTROSE INJECTION TYPE 1, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

SODIUM CHLORIDE

Quantity: 234 mg in 100 mL

Code: 451W47IQ8X

Class Code: ACTIB

MAGNESIUM ACETATE

Quantity: 21 mg in 100 mL

Code: 0E95JZY48K

Class Code: ACTIB

WATER

Code: 059QF0KO0R

Class Code: IACT

DEXTROSE MONOHYDRATE

Quantity: 5 g in 100 mL

Code: LX22YL083G

Class Code: ACTIB

POTASSIUM ACETATE

Quantity: 128 mg in 100 mL

Code: M911911U02

Class Code: ACTIB

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

Active Moieties

ANHYDROUS DEXTROSE

Code: 5SL0G7R0OK

CHLORIDE ION

Code: Q32ZN48698

POTASSIUM CATION

Code: 295O53K152

MAGNESIUM CATION

Code: T6V3LHY838

Basic Information

Regulatory Information

Company Information

Active Ingredients

WATER

HYDROCHLORIC ACID

Active Moieties

ANHYDROUS DEXTROSE

CHLORIDE ION

POTASSIUM CATION

MAGNESIUM CATION