Plasma-Lyte A

Basic Information

Product Name

Plasma-Lyte A

FDA Product Code

0338-0221

Regulatory Information

NDC Product Code

0338-0221

Application Number

NDA017378

Marketing Category

C73594

Effective Date

August 28, 2017

Territorial Authority

USA

FDA Title

PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in VIAFLEX Plastic Container

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

SODIUM CHLORIDE

Quantity: 526 mg in 100 mL

Code: 451W47IQ8X

Class Code: ACTIB

SODIUM GLUCONATE

Quantity: 502 mg in 100 mL

Code: R6Q3791S76

Class Code: ACTIB

WATER

Code: 059QF0KO0R

Class Code: IACT

SODIUM ACETATE

Quantity: 368 mg in 100 mL

Code: 4550K0SC9B

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

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

Active Moieties

CHLORIDE ION

Code: Q32ZN48698

SODIUM CATION

Code: LYR4M0NH37

Basic Information

Regulatory Information

Company Information

Active Ingredients

WATER

SODIUM HYDROXIDE

Active Moieties

CHLORIDE ION

SODIUM CATION