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Plasma-Lyte A

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

Approved
Approval ID

6ec9e61c-2c26-402f-8604-f446b2e34058

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 5, 2019

Manufacturers
FDA

Baxter Healthcare Corporation

DUNS: 005083209

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride and Magnesium Chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0338-0221
Application NumberNDA017378
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride and Magnesium Chloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 28, 2017
FDA Product Classification

INGREDIENTS (7)

SODIUM CHLORIDEActive
Quantity: 526 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
SODIUM GLUCONATEActive
Quantity: 502 mg in 100 mL
Code: R6Q3791S76
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM ACETATEActive
Quantity: 368 mg in 100 mL
Code: 4550K0SC9B
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 37 mg in 100 mL
Code: 660YQ98I10
Classification: ACTIB
MAGNESIUM CHLORIDEActive
Quantity: 30 mg in 100 mL
Code: 02F3473H9O
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/5/2019

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

Container Label

Plasma-Lyte A Injection pH 7.4 (Multiple Electrolytes Injection Type 1 USP) 1000mL Container Label

Plasma-Lyte A Injection pH 7.4 (Multiple Electrolytes Injection Type 1 USP) 1000mL Container Label

2B2544

NDC 0338-0221-04

Plasma-Lyte A

Injection pH 7.4

(Multiple Electrolytes Injection

Type 1 USP)

1000 mL

Each 100 mL contains 526 mg Sodium Chloride USP 502

mg Sodium Gluconate USP 368 mg Sodium Acetate

Trihydrate USP 37 mg Potassium Chloride USP 30 mg

Magnesium Chloride USP pH adjusted with Sodium

Hydroxide ph 7.4 (6.5 to 8.0) mEq/L Sodium 140

Potassium 5 Magnesium 3 Chloride 98 Acetate 27

Gluconate 23 Osmolarity 294 mOsmol/L (calc) Sterile

Nonpyrogenic Single dose container Additives may be

incompatible Consult with pharmacist if available When

introducing additives use aseptic technique Mix thoroughly

Do not store Dosage Intravenously as directed by a

physician See directions Cautions Squeeze and inspect

inner bag which maintains product sterility Discard if leaks

are found Must not be used in series connections Do not

use unless solution is clear Rx Only Store unit in

moisture barrier overwrap at room temperature

(25°C/77°F) until ready to use Avoid excessive heat See

insert

VIAFLEX container PL 146 plastic

BAXTER PLASMA-LYTE VIAFLEX and PL 146 are

trademarks of Baxter International Inc

For product information 1-800-933-0303

Baxter

Baxter Healthcare Corporation

Deerfield IL 60015 USA

Made in USA

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 8/5/2019

HOW SUPPLIED

PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in VIAFLEX plastic containers is available as shown below:

Code

Size
(mL)

NDC

2B2544

1000

NDC 0338-0221-04

2B2543

500

NDC 0338-0221-03

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.

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