FDA.reportPublic FDA data

Plasma-Lyte 148 (pH 7.4)

Manufacturer
Baxter Healthcare Corporation | Bieffe Medital SA
Effective date
2024-11-08
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:01:49

Label at a glance#

ProductPlasma-Lyte 148 (pH 7.4)
Active ingredientSODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE
Label structure2 sections

Label contents#

Full prescribing information#

Healthcare Professional Letter

HEALTH CARE PROVIDER LETTER SECTION

DHCP Letter 1.jpg
DHCP Letter 1.jpg
DHCP Letter 2
DHCP Letter 2

Please refer to the FDA-approved prescribing information for the drug product listed below:
• Plasma-Lyte A Injection pH 7.4 (click here)

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (1-800-332-0178).

To report product quality issues associated with this imported product, please contact Baxter Product Surveillance through Baxter Product Feedback Portal (productfeedback.baxter.com/%22%20/o%20%22https:/productfeedback.baxter.com/%22%20/t%20%22_blank)

DHCP Letter 3.jpg
DHCP Letter 3.jpg
DHCP Letter 4.jpg
DHCP Letter 4.jpg
DHCP Letter 5.jpg
DHCP Letter 5.jpg
DHCP Letter 6.jpg
DHCP Letter 6.jpg

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PlasmaLyte 1000ml Representative Container Label.jpg
PlasmaLyte 1000ml Representative Container Label.jpg

Container Label

Baxter

Viaflo

GCCE0324

1000 mL

100

200

300

400

500

600

700

800

900

Plasma-Lyte 148
(pH 7.4)

Solution for Infusion

pH 6.5 – 8.0
Isotonic
Osmolarity 295 m0sm/l (approx)

Formula per 1000ml
Sodium Chloride5.26 g
Potassium Chloride 0.37 g
Magnesium Chloride hexahydrate 0.30 g
Sodium Acetate trihydrate3.68 g
Sodium Gluconate5.02 g
Water for Injections
Sodium Hydroxide

mmol per 100 mL (approx)
Sodium 140 Chloride 98
Potassium 5 Acetate 27
Magnesium 1.5 Gluconate 23

IV administration
Read package leaflet before use
Keep out of the sight and reach of children
Do not remove from overwrap until ready for use
Do not use unless solution is clear without visible particles
and container undamaged
Do not reconnect partially used bags
Store below 30oC

POM
07
0

UN-35-03-560
1

Marketing Authorization Holder:
Baxter Healthcare Ltd.
Caxton Way
Thetford Norfolk IP 24 3SE
United Kingdom

Manufacturer:
Bieffe Medital S.A.

Ctra de Biescas-Senegüé
22666 Sabiñánigo (Huesca)
Spain

LOT

EXP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
801109magnesium chloride 0.00148 MEQ/mL / potassium chloride 0.00497 MEQ/mL / sodium acetate 0.027 MEQ/mL / sodium chloride 0.0899 MEQ/mL / sodium gluconate 5.02 MG/mL Injectable SolutionPSN2
801357PLASMA-LYTE 148 Injectable SolutionPSN2
801357magnesium chloride 0.00148 MEQ/ML / potassium chloride 0.00497 MEQ/ML / sodium acetate 0.027 MEQ/ML / sodium chloride 0.0899 MEQ/ML / sodium gluconate 5.02 MG/ML Injectable Solution [Plasma-lyte 148]SBD2
801109magnesium chloride 0.00148 MEQ/ML / potassium chloride 0.00497 MEQ/ML / sodium acetate 0.027 MEQ/ML / sodium chloride 0.0899 MEQ/ML / sodium gluconate 5.02 MG/ML Injectable SolutionSCD2
801109Magnesium Chloride 0.00148 MEQ/ML / K+ Chloride 0.00497 MEQ/ML / Sodium Acetate 0.027 MEQ/ML / NaCl 0.0899 MEQ/ML / Sodium gluconate 5.02 MG/ML Injectable SolutionSY2
801357Magnesium Chloride 0.00148 MEQ/ML / K+ Chloride 0.00497 MEQ/ML / Sodium Acetate 0.027 MEQ/ML / NaCl 0.0899 MEQ/ML / Sodium gluconate 5.02 MG/ML Injectable Solution [Plasma-lyte 148]SY2
801109Magnesium Chloride 0.00148 MEQ/ML / Pot Chloride 0.00497 MEQ/ML / Sodium Acetate 0.027 MEQ/ML / NaCl 0.0899 MEQ/ML / Sodium gluconate 5.02 MG/ML Injectable SolutionSY2
801357Magnesium Chloride 0.00148 MEQ/ML / Pot Chloride 0.00497 MEQ/ML / Sodium Acetate 0.027 MEQ/ML / NaCl 0.0899 MEQ/ML / Sodium gluconate 5.02 MG/ML Injectable Solution [Plasma-lyte 148]SY2
801357Plasma-lyte 148 Multiple Electrolytes Injectable SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
SODIUM CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-9593-01Plasma-Lyte 148 (pH 7.4)1000 mL in 1 BAGINJECTION, SOLUTION10002
0338-9593-10Plasma-Lyte 148 (pH 7.4)10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-9593-01ML - Milliliter0338-95937c967bce-af5b-40e9-ab1a-ff29b323d88712025-03-04
0338-9593-10ML - Milliliter0338-95937a03b4fe-bb49-47af-8241-affbeefd105812025-03-04

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0338-95930338-9593-01, 0338-9593-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XACTIB
SODIUM GLUCONATER6Q3791S76ACTIB
SODIUM ACETATE4550K0SC9BACTIB
POTASSIUM CHLORIDE660YQ98I10ACTIB
MAGNESIUM CHLORIDE02F3473H9OACTIB
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12024-11-08full-release2026-05-31 21:16:48

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Plasma-Lyte 148 (pH 7.4)SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDEBaxter Healthcare Corporationfe935c8d-f42d-42e4-8665-0dc66829f2312024-11-08Exact identifier
ndc (package): 0338-9593-10
ndc (package): 0338-9593-01
ndc (product): 0338-9593
ndc11 (package): 00338959301
ndc11 (package): 00338959310
spl id: 0fe5a11d-9640-4645-8d45-488a04ea6550
spl set id: fe935c8d-f42d-42e4-8665-0dc66829f231

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.