PLASMA-LYTE A- sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride injection, solution

Plasma-Lyte A by

Drug Labeling and Warnings

Plasma-Lyte A by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Company, Baxter Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Health Care Provider Letter

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Container Label

JB2544 1000 mL DIN 02339358

PLASMA-LYTE A
INJECTION

PLASMA-LYTE A,
Injectable

Norme Baxter Std

APPROX mmol/L Na – 140 K – 5 Mg – 1.5 Cl – 98
ACETATE – 27 GLUCONATE – 23 mOsmol/L – 294
pH 7.4

INTRAVENOUS FLUID AND ELECTROLYTE REPLENISHMENT
RETABLISSEMENT HYDRO-ELECTROLYTIQUE PAR INJECTION
INTRAVEINEUSE

PER 100 mL SODIUM CHLORIDE USP – 526 mg / SODIUM GLUCONATE
- 502 mg / SODIUM ACETATE TRIHYDRATE USP – 368 mg /
POTASSIUM CHLORIDE USP – 37 mg / MAGNESIUM CHLORIDE
HEXAHYDRATE USP – 30 mg / WATER FOR INJECTION USP – qs
pH MAY BE ADJUSTED WITH SODIUM HYDROXIDE

PAR 100 mL CHLORURE DE SODIUM USP – 526 mg / GLUCONATE DE
SODIUM - 502 mg / ACETATE DE SODIUM TRIHYDRATE USP – 368 mg
CHLORURE DE POTASSIUM USP – 37 mg / CHLORURE DE MAGNESIUM
HEXAHYDRATE USP – 30 mg / EAU POUR INJECTION USP – qs
LE pH AJUSTE AVEC L’HYDROXYDE DE SODIUM

CAUTIONS SINGLE USE / DISCARD UNUSED PORTION / SQUEEZE
AND INSPECT BAG / SEE DIRECTIONS FOR USE / MUST NOT BE
USED IN SERIES CONNECTIONS / STORE AT 15°C TO 25°C

ATTENTIONS USAGE UNIQUE / JETER PORTION INUTILISEE/
PRESSER ET INSPECTER LE SAC / VOIR MODE D’EMPLOI / NE DOIT
PAS ETRE MONTE EN SERIE / GARDER ENTRE ET 15°C ET 25°C

NONPYROGENIC / STERILE / APYROGENE

VIAFLEX PVC CONTAINER / CONTENANT DE PVC

BAXTER PLASMA-LYTE AND VIAFLEX ARE TRADEMARKS OF BAXTER
INTERNATIONAL INC
BAXTER PLASMA-LYTE ET VIAFLEX SONT DES MARQUES DE
COMMERCE DE BAXTER INTERNATIONAL INC

Baxter Logo
Baxter Corporation
Mississauga ON L5C 0C2

No LATEX Label

07-25-77-284

1

_

2

_

3

_

4

_

5

_

6

_

7

_

8

_

9

INGREDIENTS AND APPEARANCE

PLASMA-LYTE A 
sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-9591
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	526 mg  in 100 mL
SODIUM GLUCONATE (UNII: R6Q3791S76) (GLUCONIC ACID - UNII:R4R8J0Q44B, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM GLUCONATE	502 ug  in 100 mL
SODIUM ACETATE (UNII: 4550K0SC9B) (ACETATE ION - UNII:569DQM74SC, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM ACETATE	368 mg  in 100 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)	POTASSIUM CHLORIDE	37 mg  in 100 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	30 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-9591-12	12 in 1 CARTON	11/06/2024
1	NDC: 0338-9591-01	1000 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug for use in drug shortage		11/06/2024

Labeler - Baxter Healthcare Company (005083209)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Corporation		205087968	ANALYSIS(0338-9591) , LABEL(0338-9591) , MANUFACTURE(0338-9591) , STERILIZE(0338-9591) , PACK(0338-9591)