Multiple Electrolytes pH 5.5

Basic Information

Product Name

FDA Product Code

65219-387

Regulatory Information

NDC Product Code

65219-387

Application Number

ANDA215370

Marketing Category

C73584

Effective Date

July 1, 2021

Territorial Authority

USA

FDA Title

Multiple Electrolytes Injection, Type 1, USP, pH 5.5 in FREEFLEX Plastic Container

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

SODIUM GLUCONATE

Quantity: 502 mg in 100 mL

Code: R6Q3791S76

Class Code: ACTIB

SODIUM CHLORIDE

Quantity: 526 mg in 100 mL

Code: 451W47IQ8X

Class Code: ACTIB

MAGNESIUM CHLORIDE

Quantity: 30 mg in 100 mL

Code: 02F3473H9O

Class Code: ACTIB

SODIUM ACETATE

Quantity: 368 mg in 100 mL

Code: 4550K0SC9B

Class Code: ACTIB

Hydrochloric acid

Code: QTT17582CB

Class Code: IACT

POTASSIUM CHLORIDE

Quantity: 37 mg in 100 mL

Code: 660YQ98I10

Class Code: ACTIB

Active Moieties

CHLORIDE ION

Code: Q32ZN48698

SODIUM CATION

Code: LYR4M0NH37

Basic Information

Regulatory Information

Company Information

Active Ingredients

Hydrochloric acid

Active Moieties

CHLORIDE ION

SODIUM CATION