DIANEAL LOW CALCIUM WITH DEXTROSE

Manufacturer
Vantive US Healthcare LLC | Baxter Healthcare (Guangzhou) Co., Ltd
Effective date
2025-05-09
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 21:33:03

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

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Representative Dianeal Container Label
Representative Dianeal Container Label

Manufacturing Date

Lot Number

EXP

6AB9766 2L (APPROX 80ml EXCESS)
BaxterLogo Dianeal PD-4 Ultrabag
Low Calcium Peritoneal Dialysis Solution (Lactate-G1.5%)
[Strengths]Containing 1.5% glucose
[Ingredients](Each 100 ml contains) Ionic concentration(mmol/L)

Dextrose Hydrous

1.5 g

Sodium

132

Sodium Chloride

538mg

Calcium

1.24

Calcium Chloride

18.3mg

Magnesium

0.25

Magnesium Chloride

5.1mg

Chloride

95

Sodium Lactate

448mg

Lactate

40

[Characters]This product is a sterile, Nonpyrogen, Colorless
or slightly yellow, Clear solution, pH 5.2 (4.5 to 6.5)

Calculated osmolarity(theoretical value) 344 mOsmol/L

[Indications]Low-calcium peritoneal dialysis solutions are
indicated for use in acute and chronic renal failure patients
being maintained on continuous ambulatory peritoneal dialysis
when nondialytic medical therapy is judged to be inadequate

[Usage and Dosage] [Adverse Reactions]
[Contraindications]
See instructions for details

[Precautions]After removing the outer bag, squeeze the
dialysis bag with uniform force to check for leakage,
If leakage is found, stop using the solution;
This product should be used once;
For other details, please refer to the instructions

[Storage]Keep sealed
[Approval License Number]GYZZ H20023569
[Approval License Holder]BAXTER
HEALTHCARE(GUANGZHOU) Co., Ltd

[Legal Address]Jiaoyuan Road, Dongji industrial District,
GETDD, Guangzhou, P.R. China

[Manufacturer]BAXTER HEALTHCARE(GUANGZHOU) Co., Ltd
[Manufacturing Address]Jiaoyuan Road, Dongji industrial
District GETDD,Guangzhou, P.R. China

CONTAINER PL-146
Baxter, Dianeal, Ultrabag are registered trademarks of BAXTER INTERNATIONAL INC. in China

Representative Dianeal Carton Label
Representative Dianeal Carton Label

Low Calcium Peritoneal Dialysis Solution (Lactate-G1.5%)

[Specification] Contain 1.5% Dextrose 6AB9766

Lot G00000000 2LX 8 Bags

Manu. Date 0000-00-00 PD-4 UltraBag

Valid in 0000-00

Barcode
6 9 3 7 7 6 5 3 0 0 2 3 3 >

S/N 0000

Representative Dianeal Container Label
Representative Dianeal Container Label

Manufacturing Date

Lot Number

EXP

6AB9776 2L (APPROX 80ml EXCESS)
BaxterLogo Dianeal PD-4 Ultrabag
Low Calcium Peritoneal Dialysis Solution (Lactate-G2.5%)
[Strengths]Containing 2.5% glucose
[Ingredients](Each 100 ml contains) Ionic concentration(mmol/L)

Dextrose Hydrous

2.5 g

Sodium

132

Sodium Chloride

538mg

Calcium

1.24

Calcium Chloride

18.3mg

Magnesium

0.25

Magnesium Chloride

5.1mg

Chloride

95

Sodium Lactate

448mg

Lactate

40

[Characters]This product is a sterile, Nonpyrogen, Colorless
or slightly yellow, Clear solution, pH 5.2 (4.5 to 6.5)

Calculated osmolarity(theoretical value) 395 mOsmol/L

[Indications]Low-calcium peritoneal dialysis solutions are
indicated for use in acute and chronic renal failure patients
being maintained on continuous ambulatory peritoneal dialysis
when nondialytic medical therapy is judged to be inadequate

[Usage and Dosage] [Adverse Reactions]
[Contraindications]
See instructions for details

[Precautions]After removing the outer bag, squeeze the
dialysis bag with uniform force to check for leakage,
If leakage is found, stop using the solution;
This product should be used once;
For other details, please refer to the instructions

[Storage]Keep sealed
[Approval License Number]GYZZ H20023567
[Approval License Holder]BAXTER
HEALTHCARE(GUANGZHOU) Co., Ltd

[Legal Address]Jiaoyuan Road, Dongji industrial District,
GETDD, Guangzhou, P.R. China

[Manufacturer]BAXTER HEALTHCARE(GUANGZHOU) Co., Ltd
[Manufacturing Address]Jiaoyuan Road, Dongji industrial
District GETDD,Guangzhou, P.R. China

CONTAINER PL-146
Baxter, Dianeal, Ultrabag are registered trademarks of BAXTER INTERNATIONAL INC. in China

Representative Dianeal Carton Label
Representative Dianeal Carton Label

Low Calcium Peritoneal Dialysis Solution (Lactate-G2.5%)

[Specification] Contain 1.5% Dextrose 6AB9776

Lot G00000000 2LX 8 Bags

Manu. Date 0000-00-00 PD-4 UltraBag

Valid in 0000-00

Barcode
6 9 3 7 7 6 5 3 0 0 2 4 0 >

S/N 0000

Representative Dianeal Container Label
Representative Dianeal Container Label

Manufacturing Date

Lot Number

EXP

6AB9796 2L (APPROX 80ml EXCESS)
BaxterLogo Dianeal PD-4 Ultrabag
Low Calcium Peritoneal Dialysis Solution (Lactate-G4.25%)
[Strengths]Containing 4.25% glucose
[Ingredients](Each 100 ml contains) Ionic concentration(mmol/L)

Dextrose Hydrous

4.25 g

Sodium

132

Sodium Chloride

538mg

Calcium

1.24

Calcium Chloride

18.3mg

Magnesium

0.25

Magnesium Chloride

5.1mg

Chloride

95

Sodium Lactate

448mg

Lactate

40

[Characters]This product is a sterile, Nonpyrogen, Colorless
or slightly yellow, Clear solution, pH 5.2 (4.5 to 6.5)

Calculated osmolarity(theoretical value) 483 mOsmol/L

[Indications]Low-calcium peritoneal dialysis solutions are
indicated for use in acute and chronic renal failure patients
being maintained on continuous ambulatory peritoneal dialysis
when nondialytic medical therapy is judged to be inadequate

[Usage and Dosage] [Adverse Reactions]
[Contraindications]
See instructions for details

[Precautions]After removing the outer bag, squeeze the
dialysis bag with uniform force to check for leakage,
If leakage is found, stop using the solution;
This product should be used once;
For other details, please refer to the instructions

[Storage]Keep sealed
[Approval License Number]GYZZ H20023568
[Approval License Holder]BAXTER
HEALTHCARE(GUANGZHOU) Co., Ltd

[Legal Address]Jiaoyuan Road, Dongji industrial District,
GETDD, Guangzhou, P.R. China

[Manufacturer]BAXTER HEALTHCARE(GUANGZHOU) Co., Ltd
[Manufacturing Address]Jiaoyuan Road, Dongji industrial
District GETDD,Guangzhou, P.R. China

CONTAINER PL-146
Baxter, Dianeal, Ultrabag are registered trademarks of BAXTER INTERNATIONAL INC. in China

Representative Dianeal Carton Label
Representative Dianeal Carton Label

Low Calcium Peritoneal Dialysis Solution (Lactate-G4.25%)

[Specification] Contain 1.5% Dextrose 6AB9796

Lot G00000000 2LX 8 Bags

Manu. Date 0000-00-00 PD-4 UltraBag

Valid in 0000-00

Barcode
6 9 3 7 7 6 5 3 0 0 2 5 7 >

S/N 0000

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]SBD4
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]SBD4
800074calcium chloride 0.000996 MEQ/ML / glucose 1.7 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 4.25]SBD4
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 SolutionSCD4
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 SolutionSCD4
800066calcium chloride 0.000996 MEQ/ML / glucose 1.7 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal SolutionSCD4
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 SolutionSY4
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]SY4
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 SolutionSY4
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]SY4
800066Calcium Chloride 0.000996 MEQ/ML / Glucose 1.7 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal SolutionSY4
800074Calcium Chloride 0.000996 MEQ/ML / Glucose 1.7 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal Low Calcium 4.25]SY4
800474Dianeal Low Calcium 1.5 % Intraperitoneal SolutionSY4
800115Dianeal Low Calcium 2.5 % Intraperitoneal SolutionSY4
800074Dianeal Low Calcium 4.25 % Intraperitoneal SolutionSY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0941-0686-01DIANEAL LOW CALCIUM WITH DEXTROSE2000 mL in 1 BAGINJECTION, SOLUTION20004
0941-0686-08DIANEAL LOW CALCIUM WITH DEXTROSE8 in 1 CARTONINJECTION, SOLUTION84
0941-0690-01DIANEAL LOW CALCIUM WITH DEXTROSE2000 mL in 1 BAGINJECTION, SOLUTION20004
0941-0690-08DIANEAL LOW CALCIUM WITH DEXTROSE8 in 1 CARTONINJECTION, SOLUTION84
0941-0694-01DIANEAL LOW CALCIUM WITH DEXTROSE2000 mL in 1 BAGINJECTION, SOLUTION20004
0941-0694-08DIANEAL LOW CALCIUM WITH DEXTROSE8 in 1 CARTONINJECTION, SOLUTION84

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0941-0686DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION [VANTIVE US HEALTHCARE LLC]4Current NDC, 2 package rows20250511_0fb30b7e-8e1b-49c7-afac-2d5c01b9ff45.zip
0941-0690DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION [VANTIVE US HEALTHCARE LLC]42 package rows20250511_0fb30b7e-8e1b-49c7-afac-2d5c01b9ff45.zip
0941-0694DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION [VANTIVE US HEALTHCARE LLC]42 package rows20250511_0fb30b7e-8e1b-49c7-afac-2d5c01b9ff45.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

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 LLC0fb30b7e-8e1b-49c7-afac-2d5c01b9ff452025-05-09Exact identifier
ndc (package): 0941-0690-01
ndc (package): 0941-0690-08
ndc (package): 0941-0694-08
ndc (package): 0941-0694-01
ndc (package): 0941-0686-08
ndc (package): 0941-0686-01
ndc (product): 0941-0686
ndc (product): 0941-0694
ndc (product): 0941-0690
ndc11 (package): 00941069001
ndc11 (package): 00941069008
ndc11 (package): 00941068601
ndc11 (package): 00941069408
ndc11 (package): 00941068608
ndc11 (package): 00941069401
spl id: 34be97f0-8259-2735-e063-6394a90ad5fe
spl set id: 0fb30b7e-8e1b-49c7-afac-2d5c01b9ff45

Reported adverse events (FAERS/openFDA)#

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