FDA.reportPublic FDA data

DIANEAL LOW CALCIUM WITH DEXTROSE

Manufacturer
Vantive US Healthcare LLC | Vantive Manufacturing LImited
Effective date
2025-07-02
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 21:36:36

Label at a glance#

ProductDIANEAL LOW CALCIUM WITH DEXTROSE
Active ingredientDEXTROSE MONOHYDRATE, 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

Dianeal DHCP Letter 1
Dianeal DHCP Letter 1
Dianeal DHCP Letter 2
Dianeal DHCP Letter 2
Dianeal DHCP Letter 3
Dianeal DHCP Letter 3
Dianeal DHCP Letter 4
Dianeal DHCP Letter 4
Dianeal DHCP Letter 5
Dianeal DHCP Letter 5
Dianeal DHCP Letter 6
Dianeal DHCP Letter 6
Dianeal DHCP Letter 7
Dianeal DHCP Letter 7
Dianeal DHCP Letter 8
Dianeal DHCP Letter 8
Dianeal DHCP Letter 9
Dianeal DHCP Letter 9
Dianeal DHCP Letter 10
Dianeal DHCP Letter 10

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dianeal Representative Container Label
Dianeal Representative Container Label

Lot Exp

BaxterLogo FPB9718R 2500 ml

DIANEAL PD4 Glucose 1,36% w/v / 13,6 mg/ml

Solution for Peritoneal Dialysis

Formula

g/l

Osmolarity

344mOsmol/l

Anhydrous Glucose

C 6H 12O 6

13,6 g

mmol/l

Sodium Chloride

NaCl

5,38 g

Na +

  1. 132

Sodium Lactate

C 3H 5NaO 3

4,48 g

Ca ++

1,25

Calcium Chloride

CaCl 2·2H 2O

0,184 g

Mg ++

0,25

Magnesium Chloride

MgCl 2·6H 2O

0,051 g

Cl -

95

Water for Injections to 1000ml

C 3H 5O 3 -

40

Free from Bacterial Endotoxins
For Intraperitoneal infusion
Not for intravenous infusion
Do not use unless the solution is clear and the container undamaged
For single use only
Once removed from the overpouch use immediately
Discard unused solution
Do not store above 25°C
Do not refrigerate or freeze
Keep out of the sight and reach of children

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

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

POM Symbol

PA 2299/015/001
PL 00116/0230
MA 1277/01001

CB-35-04-620

Dianeal Representative Carton Label
Dianeal Representative Carton Label

FPB9718R 2500 ml x 4

Dianeal PD4 Glucose 1.36% w/v / 13,6 mg/ml

Solution for Peritoneal Dialysis

Formula

g/l

Anhydrous Glucose

13,6 g

Sodium Chloride

5,38 g

Sodium Lactate

4,48 g

Calcium Chloride

0,184 g

Magnesium Chloride

0,051 g

Water for Injections to 1000 ml

Free from bacterial endotoxins.
For intraperitoneal infusion.
Not for intravenous use. For single use only.
Do not use unless the solution is clear and the container undamaged.
Once removed from the overpouch use immediately.
Discard unused solution. 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

PA 2299/015/001 PL 00116/0230 MA 1277/01001

POM Symbol

Lot:

Single bag with
Luer connector

Do not store above 25°C.
Do not refrigerate or
freeze.

88-46-13-208

Barcode
(01)50085412574429(17)201200(10)88B88B88B8

Dianeal PD4 Glucose FPB9718R

1.36% w/v / 13,6 mg/ml 2500 ml x 4

Lot:

Dianeal Representative Container Label
Dianeal Representative Container Label

Lot Exp

Vantive Logo FPB9718R 2500 ml

DIANEAL PD4 Glucose 1,36% w/v / 13,6 mg/ml

Solution for Peritoneal Dialysis

Formula

g/l

Osmolarity

344mOsmol/l

Anhydrous Glucose

C 6H 12O 6

13,6 g

mmol/l

Sodium Chloride

NaCl

5,38 g

Na +

  1. 132

Sodium Lactate

C 3H 5NaO 3

4,48 g

Ca ++

1,25

Calcium Chloride

CaCl 2·2H 2O

0,184 g

Mg ++

0,25

Magnesium Chloride

MgCl 2·6H 2O

0,051 g

Cl -

95

Water for Injections to 1000ml

C 3H 5O 3 -

40

Free from Bacterial Endotoxins
For Intraperitoneal infusion
Not for intravenous infusion
Do not use unless the solution is clear and the container undamaged
For single use only
Once removed from the overpouch use immediately
Discard unused solution
Do not store above 25°C
Do not refrigerate or freeze
Keep out of the sight and reach of children

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

POM Symbol

PL 58711/0002

CB-35-05-245

Dianeal Representative Carton Label
Dianeal Representative Carton Label

FPB9718R 2500 ml x 4

Dianeal PD4 Glucose 1.36% w/v / 13,6 mg/ml

Solution for Peritoneal Dialysis

Formula

g/l

Anhydrous Glucose

13,6 g

Sodium Chloride

5,38 g

Sodium Lactate

4,48 g

Calcium Chloride

0,184 g

Magnesium Chloride

0,051 g

Water for Injections to 1000 ml

Free from bacterial endotoxins.
For intraperitoneal infusion.
Not for intravenous use. For single use only.
Do not use unless the solution is clear and the container undamaged.
Once removed from the overpouch use immediately.
Discard unused solution. Keep out of the sight and reach of children.

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

PL 58711/0002

POM Symbol

Lot:

UK Only

Single bag with
Luer connector

Do not store above 25°C.
Do not refrigerate or
freeze.

88-46-13-978

Barcode
(01)57332414203561(17)201200(10)88B88B88B8

Dianeal PD4 Glucose FPB9718R

1.36% w/v / 13,6 mg/ml 2500 ml x 4

Lot:

Dianeal Representative Container Label
Dianeal Representative Container Label

Lot Exp

BaxterLogo FPB9728R 2500 ml

DIANEAL PD4 Glucose 2,27% w/v / 22,7 mg/ml

Solution for Peritoneal Dialysis

Formula

g/l

Osmolarity

395mOsmol/l

Anhydrous Glucose

C 6H 12O 6

22,7 g

mmol/l

Sodium Chloride

NaCl

5,38 g

Na +

  1. 132

Sodium Lactate

C 3H 5NaO 3

4,48 g

Ca ++

1,25

Calcium Chloride

CaCl 2·2H 2O

0,184 g

Mg ++

0,25

Magnesium Chloride

MgCl 2·6H 2O

0,051 g

Cl -

95

Water for Injections to 1000ml

C 3H 5O 3 -

40

Free from Bacterial Endotoxins
For Intraperitoneal infusion
Not for intravenous infusion
Do not use unless the solution is clear and the container undamaged
For single use only
Once removed from the overpouch use immediately
Discard unused solution
Do not store above 25°C
Do not refrigerate or freeze
Keep out of the sight and reach of children

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

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

POM Symbol

PA 2299/015/002
PL 00116/0231
MA 1277/01002

CB-35-04-621

Dianeal Representative Carton Label
Dianeal Representative Carton Label

FPB9728R 2500 ml x 4

Dianeal PD4 Glucose 2.27% w/v / 22,7 mg/ml

Solution for Peritoneal Dialysis

Formula

g/l

Anhydrous Glucose

22,7 g

Sodium Chloride

5,38 g

Sodium Lactate

4,48 g

Calcium Chloride

0,184 g

Magnesium Chloride

0,051 g

Water for Injections to 1000 ml

Free from bacterial endotoxins.
For intraperitoneal infusion.
Not for intravenous use. For single use only.
Do not use unless the solution is clear and the container undamaged.
Once removed from the overpouch use immediately.
Discard unused solution. 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

PA 2299/015/002 PL 00116/0231 MA 1277/01002

POM Symbol

Lot:

Single bag with
Luer connector

Do not store above 25°C.
Do not refrigerate or
freeze.

88-46-13-209

Barcode
(01)50085412574436(17)201200(10)88B88B88B8

Dianeal PD4 Glucose FPB9728R

2.27% w/v / 22,7 mg/ml 2500 ml x 4

Lot:

Dianeal Representative Container Label
Dianeal Representative Container Label

Lot Exp

Vantive Logo FPB9728R 2500 ml

DIANEAL PD4 Glucose 2,27% w/v / 22,7 mg/ml

Solution for Peritoneal Dialysis

Formula

g/l

Osmolarity

395mOsmol/l

Anhydrous Glucose

C 6H 12O 6

22,7 g

mmol/l

Sodium Chloride

NaCl

5,38 g

Na +

  1. 132

Sodium Lactate

C 3H 5NaO 3

4,48 g

Ca ++

1,25

Calcium Chloride

CaCl 2·2H 2O

0,184 g

Mg ++

0,25

Magnesium Chloride

MgCl 2·6H 2O

0,051 g

Cl -

95

Water for Injections to 1000ml

C 3H 5O 3 -

40

Free from Bacterial Endotoxins
For Intraperitoneal infusion
Not for intravenous infusion
Do not use unless the solution is clear and the container undamaged
For single use only
Once removed from the overpouch use immediately
Discard unused solution
Do not store above 25°C
Do not refrigerate or freeze
Keep out of the sight and reach of children

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

POM Symbol

PL 58711/0003

CB-35-05-246

Dianeal Representative Carton Label
Dianeal Representative Carton Label

FPB9728R 2500 ml x 4

Dianeal PD4 Glucose 2.27% w/v / 22,7 mg/ml

Solution for Peritoneal Dialysis

Formula

g/l

Anhydrous Glucose

22,7 g

Sodium Chloride

5,38 g

Sodium Lactate

4,48 g

Calcium Chloride

0,184 g

Magnesium Chloride

0,051 g

Water for Injections to 1000 ml

Free from bacterial endotoxins.
For intraperitoneal infusion.
Not for intravenous use. For single use only.
Do not use unless the solution is clear and the container undamaged.
Once removed from the overpouch use immediately.
Discard unused solution. Keep out of the sight and reach of children.

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

PL 58711/0003

POM Symbol

Lot:

UK Only

Single bag with
Luer connector

Do not store above 25°C.
Do not refrigerate or
freeze.

88-46-13-979

Barcode
(01)5733241420885(17)201200(10)88B88B88B8

Dianeal PD4 Glucose FPB9728R

2.27% w/v / 22,7 mg/ml 2500 ml x 4

Lot:

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
800474calcium chloride 0.000996 MEQ/ML / glucose 0.6 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal Low Calcium 1.5]SBD6
800115calcium chloride 0.000996 MEQ/ML / glucose 1 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal Low Calcium 2.5]SBD6
800472calcium chloride 0.000996 MEQ/ML / glucose 0.6 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal SolutionSCD6
800111calcium chloride 0.000996 MEQ/ML / glucose 1 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal SolutionSCD6
800472Calcium Chloride 0.000996 MEQ/ML / Glucose 0.6 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal SolutionSY6
800474Calcium Chloride 0.000996 MEQ/ML / Glucose 0.6 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal Low Calcium 1.5]SY6
800111Calcium Chloride 0.000996 MEQ/ML / Glucose 1 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal SolutionSY6
800115Calcium Chloride 0.000996 MEQ/ML / Glucose 1 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal Low Calcium 2.5]SY6
800474Dianeal Low Calcium 1.5 % Intraperitoneal SolutionSY6
800115Dianeal Low Calcium 2.5 % Intraperitoneal SolutionSY6

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
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0941-0733-01DIANEAL LOW CALCIUM WITH DEXTROSE2500 mL in 1 BAGINJECTION, SOLUTION25006
0941-0733-04DIANEAL LOW CALCIUM WITH DEXTROSE4 in 1 CARTONINJECTION, SOLUTION46
0941-0735-01DIANEAL LOW CALCIUM WITH DEXTROSE2500 mL in 1 BAGINJECTION, SOLUTION25006
0941-0735-04DIANEAL LOW CALCIUM WITH DEXTROSE4 in 1 CARTONINJECTION, SOLUTION46

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0941-07330941-0733-01, 0941-0733-04
0941-07350941-0735-01, 0941-0735-04

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
DEXTROSE MONOHYDRATELX22YL083GACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
SODIUM LACTATETU7HW0W0QTACTIB
CALCIUM CHLORIDEM4I0D6VV5MACTIB
MAGNESIUM CHLORIDE02F3473H9OACTIB
DEXTROSE MONOHYDRATELX22YL083GACTIB
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLC0956bd7c-d46f-483a-bf2c-9e11c6111ebf2025-07-02Exact identifier
ndc (package): 0941-0735-01
ndc (package): 0941-0733-04
ndc (package): 0941-0733-01
ndc (package): 0941-0735-04
ndc (product): 0941-0733
ndc (product): 0941-0735
ndc11 (package): 00941073504
ndc11 (package): 00941073301
ndc11 (package): 00941073304
ndc11 (package): 00941073501
spl id: 38f81b8c-e9ff-2e12-e063-6394a90aac6f
spl set id: 0956bd7c-d46f-483a-bf2c-9e11c6111ebf

Reported adverse events (FAERS/openFDA)#

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