FDA.reportPublic FDA data

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 21:33:05

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

6AB9768E 2500ml
(APPROX 90ml EXCESS)
3000ml NOMINAL SIZE CONTAINER

BaxterLogo

Dianeal ®Low Calcium(2.5mEq/L)
Peritoneal Dialysis Solution
With 1.5% Dextrose

EACH 100 ml CONTAINS1.5g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM
CHLORIDE USP pH5.2 (4.5 to 6.5)
mEq/LSODIUM 132 CALCIUM 2.5 MAGNESIUM 0.5
CHLORIDE 95 LACTATE 40
OSMOLARITY344 mOsmol/L(CALC)
STERILE NON PYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER
THE DIRECTION OF A PHYSICIAN

READ PACKAGE INSERT FOR FULL INFORMATION
FOR INTRAPERITONEAL ADMINISTRATION ONLY
CAUTIONSSQUEEZE AND INSPECT INNER BAG WHICH
MAINTAINS PRODUCT STERILITY DISCARD IF
LEAKS ARE FOUND
DO NOT USE UNLESS SOLUTION IS CLEAR
DISCARD UNUSED PORTION
STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM
TEMPERATURE (UNDER25°C) UNTIL READY TO USE
AVOID EXCESSIVE HEAT SEE INSERT

Ultrabag TM CONTAINER PL-146 PLASTIC

MANUFACTURED BY
BAXTER HEALTHCARE (GUANGZHOU) CO LTD
GUANGZHOU CHINA
(AN AFFILIATE OF BAXTER WORLD TRADE INC USA)
HK-62710
DIRECTIONSTO BE USED AS DIRECTED BY THE PHYSICIAN

Prescription Drug
Manufacturer Address:
Jiaoyuan Road, Dongji Industrial District,
GETDD, Guangzhou, P.R. China

Low Calcium 1.5% Dextrose

Representative Dianeal Carton Label
Representative Dianeal Carton Label

1.5 LOW CALCIUM WITH 1.5% DEXTROSE
ULTRABAG 2500mlX4
LOT G00000000 EXP JAN 00

6AB9768E

S/N 0000

Representative Dianeal Container Label
Representative Dianeal Container Label

6AB9778E 2500ml
(APPROX 90ml EXCESS)
3000ml NOMINAL SIZE CONTAINER

BaxterLogo

Dianeal ®Low Calcium(2.5mEq/L)
Peritoneal Dialysis Solution
With 2.5% Dextrose

EACH 100ml CONTAINS2.5g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM
CHLORIDE USP pH5.2 (4.5 to 6.5)
mEq/LSODIUM 132 CALCIUM 2.5 MAGNESIUM 0.5
CHLORIDE 95 LACTATE 40
OSMOLARITY395 mOsmol/L(CALC)
STERILE NON PYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER
THE DIRECTION OF A PHYSICIAN

READ PACKAGE INSERT FOR FULL INFORMATION
FOR INTRAPERITONEAL ADMINISTRATION ONLY
CAUTIONSSQUEEZE AND INSPECT INNER BAG WHICH
MAINTAINS PRODUCT STERILITY DISCARD IF
LEAKS ARE FOUND
DO NOT USE UNLESS SOLUTION IS CLEAR
DISCARD UNUSED PORTION
STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM
TEMPERATURE (UNDER25°C) UNTIL READY TO USE
AVOID EXCESSIVE HEAT SEE INSERT

Ultrabag TM CONTAINER PL-146 PLASTIC

MANUFACTURED BY
BAXTER HEALTHCARE (GUANGZHOU) CO LTD
GUANGZHOU CHINA
(AN AFFILIATE OF BAXTER WORLD TRADE INC USA)
HK-62709
DIRECTIONSTO BE USED AS DIRECTED BY THE PHYSICIAN

Prescription Drug
Manufacturer Address:
Jiaoyuan Road, Dongji Industrial District,
GETDD, Guangzhou, P.R. China

Low Calcium 2.5% Dextrose

Representative Dianeal Carton Label
Representative Dianeal Carton Label

2.5 LOW CALCIUM WITH 2.5% DEXTROSE
ULTRABAG 2500mlX4
LOT G00000000 EXP JAN 00

6AB9778E

S/N 0000

Representative Dianeal Container Label
Representative Dianeal Container Label

6AB9798E 2500ml
(APPROX 90ml EXCESS)
3000ml NOMINAL SIZE CONTAINER

BaxterLogo

Dianeal ®Low Calcium(2.5mEq/L)
Peritoneal Dialysis Solution
With 4.25% Dextrose

EACH 100ml CONTAINS4.25g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM
CHLORIDE USP pH5.2 (4.5 to 6.5)
mEq/LSODIUM 132 CALCIUM 2.5 MAGNESIUM 0.5
CHLORIDE 95 LACTATE 40 OSMOLARITY483 mOsmol/L(CALC)
STERILE NON PYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER
THE DIRECTION OF A PHYSICIAN

WARNINGEXTENSIVE USE OF THIS SOLUTION DURING
ONE PERITONEAL DIALYSIS PROCEDURE CAN RESULT IN
SIGNIFICANT REMOVAL OF WATER FROM THE PATIENT
READ PACKAGE INSERT FOR FULL INFORMATION
FOR INTRAPERITONEAL ADMINISTRATION ONLY
CAUTIONSSQUEEZE AND INSPECT INNER BAG WHICH
MAINTAINS PRODUCT STERILITY DISCARD IF
LEAKS ARE FOUND
DO NOT USE UNLESS SOLUTION IS CLEAR
DISCARD UNUSED PORTION
STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM
TEMPERATURE (UNDER25°C) UNTIL READY TO USE
AVOID EXCESSIVE HEAT SEE INSERT

Ultrabag TM CONTAINER PL-146 PLASTIC

MANUFACTURED BY
BAXTER HEALTHCARE (GUANGZHOU) CO LTD
GUANGZHOU CHINA
(AN AFFILIATE OF BAXTER WORLD TRADE INC USA)
HK-62711
DIRECTIONSTO BE USED AS DIRECTED BY THE PHYSICIAN

Prescription Drug
Manufacturer Address:
Jiaoyuan Road, Dongji Industrial District,
GETDD, Guangzhou, P.R. China

Low Calcium 4.25% Dextrose

Representative Dianeal Carton Label
Representative Dianeal Carton Label

4.25 LOW CALCIUM WITH 4.25% DEXTROSE
ULTRABAG 2500mlX4
LOT G00000000 EXP JAN 00

6AB9798E

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#

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

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0941-0684-01DIANEAL LOW CALCIUM WITH DEXTROSE2500 mL in 1 BAGINJECTION, SOLUTION25004
0941-0684-04DIANEAL LOW CALCIUM WITH DEXTROSE4 in 1 CARTONINJECTION, SOLUTION44
0941-0688-01DIANEAL LOW CALCIUM WITH DEXTROSE2500 mL in 1 BAGINJECTION, SOLUTION25004
0941-0688-04DIANEAL LOW CALCIUM WITH DEXTROSE4 in 1 CARTONINJECTION, SOLUTION44
0941-0692-01DIANEAL LOW CALCIUM WITH DEXTROSE2500 mL in 1 BAGINJECTION, SOLUTION25004
0941-0692-04DIANEAL LOW CALCIUM WITH DEXTROSE4 in 1 CARTONINJECTION, SOLUTION44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0941-0684DIANEAL 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_b0f2c9a2-d9d4-4907-a324-e7a26d489f44.zip
0941-0688DIANEAL 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_b0f2c9a2-d9d4-4907-a324-e7a26d489f44.zip
0941-0692DIANEAL 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_b0f2c9a2-d9d4-4907-a324-e7a26d489f44.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0941-06840941-0684-01, 0941-0684-04
0941-06880941-0688-01, 0941-0688-04
0941-06920941-0692-01, 0941-0692-04

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DEXTROSE MONOHYDRATELX22YL083GACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
SODIUM LACTATETU7HW0W0QTACTIB
CALCIUM CHLORIDEM4I0D6VV5MACTIB
MAGNESIUM CHLORIDE02F3473H9OACTIB
WATER059QF0KO0RIACT
DEXTROSE MONOHYDRATELX22YL083GACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
SODIUM LACTATETU7HW0W0QTACTIB
CALCIUM CHLORIDEM4I0D6VV5MACTIB
MAGNESIUM CHLORIDE02F3473H9OACTIB
WATER059QF0KO0RIACT
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 LLCb0f2c9a2-d9d4-4907-a324-e7a26d489f442025-05-09Exact identifier
ndc (package): 0941-0684-04
ndc (package): 0941-0688-04
ndc (package): 0941-0684-01
ndc (package): 0941-0692-04
ndc (package): 0941-0692-01
ndc (package): 0941-0688-01
ndc (product): 0941-0688
ndc (product): 0941-0684
ndc (product): 0941-0692
ndc11 (package): 00941068401
ndc11 (package): 00941068804
ndc11 (package): 00941069201
ndc11 (package): 00941068404
ndc11 (package): 00941069204
ndc11 (package): 00941068801
spl id: 34bec065-8895-a650-e063-6294a90ae112
spl set id: b0f2c9a2-d9d4-4907-a324-e7a26d489f44

Reported adverse events (FAERS/openFDA)#

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