FDA.reportPublic FDA data

EXTRANEAL Solution for Peritoneal Dialysis

Manufacturer
Vantive US Healthcare LLC | Baxter Healthcare S.A.
Effective date
2025-05-07
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 21:32:57

Label at a glance#

ProductEXTRANEAL
Active ingredientICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE
Label structure2 sections

Label contents#

Full prescribing information#

Health Care Provider Letter

HEALTH CARE PROVIDER LETTER SECTION

Extraneal DHCP Letter 1
Extraneal DHCP Letter 1
Extraneal DHCP Letter 2
Extraneal DHCP Letter 2
Extraneal DHCP Letter 3
Extraneal DHCP Letter 3
Extraneal DHCP Letter 4
Extraneal DHCP Letter 4
Extraneal DHCP Letter 5
Extraneal DHCP Letter 5
Extraneal DHCP Letter 6
Extraneal DHCP Letter 6
Extraneal DHCP Letter 7
Extraneal DHCP Letter 7
Extraneal DHCP Letter 8
Extraneal DHCP Letter 8

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Representative Extraneal Container Label -FPB5268C.jpg
Representative Extraneal Container Label -FPB5268C.jpg

Lot EXP
B5268 2000 ml
Baxter
EXTRANEAL Solution for Peritoneal Dialysis

Formula 1000 ml

mmol/l

Icodextrin

75 g

Na+

133

Sodium Chloride

5,4 g

Ca++

1,75

Sodium (S)-lactate

4,5 g

Mg++

0,25

Calcium Chloride 2H 20

0,257 g

Clˉ

96

Magnesium Chloride 6H 20

0,051 g

C 3H 50 3ˉ

40

Water for Injections

Osmolarity

284mOsm/l

Hydrochloric acid or sodium hydroxide (for pH adjustment)

pH

5,0 – 6,0

For intraperitoneal use
Not for intravenous use
Use as directed by a physician
Read the package leaflet before use
Keep out of the sight and reach of children
Nonpyrogenic
Do not store below 4°C
Do not use unless solution is clear and container undamaged
For single use only
Once removed from the overpouch use immediately
Discard unused solution

UK:
Baxter Healthcare Ltd
Caxton Way, Thetford, Norfolk, IP24 3SE,
United Kingdom

IE and MT:
Baxter Holding B.V.,
Kobaltweg 49, 3542CE, Utrecht,
Netherlands

PL 00116/0266
PA 2299/017/001
MA 1277/01101

POM Symbol

Manufactured by Baxter Healthcare S A IRL-Castlebar CB-35-04-608

Representative Extraneal Carton Label - FPB5268C
Representative Extraneal Carton Label - FPB5268C

EXTRANEAL
FPB5268C
2000 ml x 5

Solution for Peritoneal Dialysis

1000 ml

Icodextrin

75 g

Sodium Chloride

5,4 g

Sodium (S)-lactate

4,5 g

Calcium Chloride 2H 20

0,257 g

Magnesium Chloride 6H 20

0,051 g

Water for injections to 1000 ml

Sodium hydroxide or hydrochloric acid (for pH adjustment)

For intraperitoneal use
Not for intravenous infusion
Keep out of the sight and reach of children

UK: Baxter Healthcare Limited Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom
IE and MT: Baxter Holding B.V. Kobaltweg 49, 3542CE, Utrecht, Netherlands

88-46-13-196

Lot: EXP

Do not store below 4°C

Twin bag with Luer connector

MA 1277/01101
PA 2299/017/001
PL 00116/0266

POM Symbol

Barcode
(01)554 13760423833(17)201200(10)88C88C88B2

EXTRANEAL
FPB5268C
2000 ml x 5

Lot: EXP

Vantive Representative Extraneal Container Label - FPB5268C
Vantive Representative Extraneal Container Label - FPB5268C

Lot EXP
B5268 2000 ml
Vantive
EXTRANEAL Solution for Peritoneal Dialysis

Formula 1000 ml

mmol/l

Icodextrin

75 g

Na+

133

Sodium Chloride

5,4 g

Ca++

1,75

Sodium (S)-lactate

4,5 g

Mg++

0,25

Calcium Chloride 2H 20

0,257 g

Clˉ

96

Magnesium Chloride 6H 20

0,051 g

C 3H 50 3ˉ

40

Water for Injections

Osmolarity

284mOsm/l

Hydrochloric acid or sodium hydroxide (for pH adjustment)

pH

5,0 – 6,0

For intraperitoneal use
Not for intravenous use
Use as directed by a physician
Read the package leaflet before use
Keep out of the sight and reach of children
Nonpyrogenic
Do not store below 4°C
Do not use unless solution is clear and container undamaged
For single use only
Once removed from the overpouch use immediately
Discard unused solution

Vantive Limited
Wavertree Technology Park
2 Wavertree Boulevard
Liverpool, L7 9PE
United Kingdom

PL 58711/0005

POM Symbol

CB-35-05-250

Vantive Representative Extraneal Carton Label - FPB5268C
Vantive Representative Extraneal Carton Label - FPB5268C

EXTRANEAL
FPB5268C
2000 ml x 5

Solution for Peritoneal Dialysis

1000 ml

Icodextrin

75 g

Sodium Chloride

5,4 g

Sodium (S)-lactate

4,5 g

Calcium Chloride 2H 20

0,257 g

Magnesium Chloride 6H 20

0,051 g

Water for injections to 1000 ml

Sodium hydroxide or hydrochloric acid (for pH adjustment)

For intraperitoneal use
Not for intravenous infusion
Keep out of the sight and reach of children

Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom

88-46-14-007

Lot: EXP

UK Only

Do not store below 4°C

Twin bag with Luer connector

PL 58711/0005

POM Symbol

Barcode
(01)57332414203103 (17)201200(10)88C88C88B2

EXTRANEAL
FPB5268C
2000 ml x 5

Lot: EXP

Representative Extraneal Container Label - FPB5270
Representative Extraneal Container Label - FPB5270

Lot EXP
B5270 2500 ml
Baxter
EXTRANEAL Solution for Peritoneal Dialysis

Formula 1000 ml

mmol/l

Icodextrin

75 g

Na+

133

Sodium Chloride

5,4 g

Ca++

1,75

Sodium (S)-lactate

4,5 g

Mg++

0,25

Calcium Chloride 2H 20

0,257 g

Clˉ

96

Magnesium Chloride 6H 20

0,051 g

C 3H 50 3ˉ

40

Water for Injections

Osmolarity

284mOsm/l

Hydrochloric acid or sodium hydroxide (for pH adjustment)

pH

5,0 – 6,0

For intraperitoneal use
Not for intravenous use
Use as directed by a physician
Read the package leaflet before use
Keep out of the sight and reach of children
Nonpyrogenic
Do not store below 4°C
Do not use unless solution is clear and container undamaged
For single use only
Once removed from the overpouch use immediately
Discard unused solution

UK:
Baxter Healthcare Ltd
Caxton Way, Thetford, Norfolk, IP24 3SE,
United Kingdom

IE and MT:
Baxter Holding B.V., Kobaltweg 49,
3542CE, Utrecht, Netherlands

PL 00116/0266
PA 2299/017/001
MA 1277/01101

POM Symbol

Manufactured by Baxter Healthcare S A IRL-Castlebar CB-35-04-609

Representative Extraneal Carton Label - FPB5270
Representative Extraneal Carton Label - FPB5270

EXTRANEAL
FPB5270
2500 ml x 4

Solution for Peritoneal Dialysis

1000 ml

Icodextrin

75 g

Sodium Chloride

5,4 g

Sodium (S)-lactate

4,5 g

Calcium Chloride 2H 20

0,257 g

Magnesium Chloride 6H 20

0,051 g

Water for injections to 1000 ml

Sodium hydroxide or hydrochloric acid (for pH adjustment)

For intraperitoneal use
Not for intravenous infusion
Keep out of the sight and reach of children

UK: Baxter Healthcare Limited Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom
IE and MT: Baxter Holding B.V. Kobaltweg 49, 3542CE, Utrecht, Netherlands

88-46-13-197

Lot: EXP

Do not store below 4°C

Twin bag with Luer connector

MA 1277/01101
PA 2299/017/001
PL 00116/0266

POM Symbol

Barcode
(01)50085412574412(17)201200(10)88C88C88B2

EXTRANEAL
FPB5270
2000 ml x 4

Lot: EXP

Vantive Representative Extraneal Container Label - FPB5270
Vantive Representative Extraneal Container Label - FPB5270

Lot EXP
B5270 2500 ml
Vantive
EXTRANEAL Solution for Peritoneal Dialysis

Formula 1000 ml

mmol/l

Icodextrin

75 g

Na+

133

Sodium Chloride

5,4 g

Ca++

1,75

Sodium (S)-lactate

4,5 g

Mg++

0,25

Calcium Chloride 2H 20

0,257 g

Clˉ

96

Magnesium Chloride 6H 20

0,051 g

C 3H 50 3ˉ

40

Water for Injections

Osmolarity

284mOsm/l

Hydrochloric acid or sodium hydroxide (for pH adjustment)

pH

5,0 – 6,0

For intraperitoneal use
Not for intravenous use
Use as directed by a physician
Read the package leaflet before use
Keep out of the sight and reach of children
Nonpyrogenic
Do not store below 4°C
Do not use unless solution is clear and container undamaged
For single use only
Once removed from the overpouch use immediately
Discard unused solution

Vantive Limited
Wavertree Technology Park
2 Wavertree Boulevard
Liverpool, L7 9PE
United Kingdom

PL 58711/0005

POM Symbol

CB-35-05-251

Vantive Representative Extraneal Carton Label - FPB5270
Vantive Representative Extraneal Carton Label - FPB5270

EXTRANEAL
FPB5270
2500 ml x 4

Solution for Peritoneal Dialysis

1000 ml

Icodextrin

75 g

Sodium Chloride

5,4 g

Sodium (S)-lactate

4,5 g

Calcium Chloride 2H 20

0,257 g

Magnesium Chloride 6H 20

0,051 g

Water for injections to 1000 ml

Sodium hydroxide or hydrochloric acid (for pH adjustment)

For intraperitoneal use
Not for intravenous infusion
Keep out of the sight and reach of children

Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom

88-46-14-008

Lot: EXP

UK Only

Do not store below 4°C

Twin bag with Luer connector

PL 58711/0005

POM Symbol

Barcode
(01)57332414202649 (17)201200(10)88C88C88B2

EXTRANEAL
FPB5270

2500 ml x 4

Lot: EXP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1100746Extraneal 0.00232 MEQ/mL / 75 MG/mL / 0.000533 MEQ/mL / 0.0915 MEQ/mL / 0.04 MEQ/mL Injectable SolutionPSN5
1100746calcium chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / magnesium chloride 0.000533 MEQ/ML / sodium chloride 0.0915 MEQ/ML / sodium lactate 0.04 MEQ/ML Injectable Solution [Extraneal]SBD5
1100742calcium chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / magnesium chloride 0.000533 MEQ/ML / sodium chloride 0.0915 MEQ/ML / sodium lactate 0.04 MEQ/ML Injectable SolutionSCD5
1100742Calcium Chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / Magnesium Chloride 0.000533 MEQ/ML / NaCl 0.0915 MEQ/ML / Sodium Lactate 0.04 MEQ/ML Injectable SolutionSY5
1100746Calcium Chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / Magnesium Chloride 0.000533 MEQ/ML / NaCl 0.0915 MEQ/ML / Sodium Lactate 0.04 MEQ/ML Injectable Solution [Extraneal]SY5
1100746Extraneal (calcium chloride 25.7 MG / icodextrin 7.5 GM / magnesium chloride 5.08 MG / sodium chloride 535 MG / sodium lactate 448 MG) per 100 ML Intraperitoneal SolutionSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LACTIC ACID, UNSPECIFIED FORM Pharmacologic Class Indexing1Indexing - Pharmacologic Class20220121

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
0941-0681-01EXTRANEAL2500 mL in 1 BAGINJECTION, SOLUTION25005
0941-0681-04EXTRANEAL4 in 1 CARTONINJECTION, SOLUTION45
0941-0717-01EXTRANEAL2000 mL in 1 BAGINJECTION, SOLUTION20005
0941-0717-05EXTRANEAL5 in 1 CARTONINJECTION, SOLUTION55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0941-0681EXTRANEAL (ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) INJECTION, SOLUTION [VANTIVE US HEALTHCARE LLC]5Current NDC, 2 package rows20250508_e18bacfe-af60-49dc-bd30-cb3c29fa16db.zip
0941-0717EXTRANEAL (ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) INJECTION, SOLUTION [VANTIVE US HEALTHCARE LLC]52 package rows20250508_e18bacfe-af60-49dc-bd30-cb3c29fa16db.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0941-06810941-0681-01, 0941-0681-04
0941-07170941-0717-01, 0941-0717-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ICODEXTRIN2NX48Z0A9GACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
SODIUM LACTATETU7HW0W0QTACTIB
CALCIUM CHLORIDEM4I0D6VV5MACTIB
MAGNESIUM CHLORIDE02F3473H9OACTIB
ICODEXTRIN2NX48Z0A9GACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
SODIUM LACTATETU7HW0W0QTACTIB
CALCIUM CHLORIDEM4I0D6VV5MACTIB
MAGNESIUM CHLORIDE02F3473H9OACTIB

Source Document#

Source XML

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EXTRANEALICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEVantive US Healthcare LLCe18bacfe-af60-49dc-bd30-cb3c29fa16db2025-05-07Exact identifier
ndc (package): 0941-0717-01
ndc (package): 0941-0681-01
ndc (package): 0941-0717-05
ndc (package): 0941-0681-04
ndc (product): 0941-0681
ndc (product): 0941-0717
ndc11 (package): 00941068101
ndc11 (package): 00941071705
ndc11 (package): 00941071701
ndc11 (package): 00941068104
spl id: 348e030f-39eb-ac7c-e063-6394a90a4602
spl set id: e18bacfe-af60-49dc-bd30-cb3c29fa16db
EXTRANEALICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEVantive US Healthcare LLC2b327b13-a0e9-4b2c-9875-4470998e2e302025-05-07Exact identifier
ndc (product): 0941-0681

Reported adverse events (FAERS/openFDA)#

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