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
3
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

Dianeal Representative Container Label
Dianeal Representative Container Label

6AB9770E 6000ml
(APPROX 225ml EXCESS)

BaxterLogo

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

EACH 100ml CONTAINS1.5 g 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 (UNDER 25°C) UNTIL READY TO USE
AVOID EXCESSIVE HEAT SEE INSERT

Ambu-Flex™ IIICONTAINER PL-146 ®PLASTIC

MANUFACTURED BY
BAXTER HEALTHCARE (GUANGZHOU) CO LTD
GUANGZHOU CHINA
(AN AFFI LIATE OF BAXTER WORLD TRADE INC USA)
HK-42530
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

Dianeal Representative Carton Label
Dianeal Representative Carton Label

1.5 LOW CALCIUM WITH 1.5% DEXTROSE 6000mlX2
LOT G00000000 EXP JAN 00 6AB9770E S/N 0000

Dianeal Representative Container Label
Dianeal Representative Container Label

6AB9771E 6000ml
(APPROX 225ml EXCESS)

BaxterLogo

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

EACH 100ml CONTAINS2.5 g 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 (UNDER 25°C) UNTIL READY TO USE
AVOID EXCESSIVE HEAT SEE INSERT

Ambu-Flex™ IIICONTAINER PL-146 ®PLASTIC

MANUFACTURED BY
BAXTER HEALTHCARE (GUANGZHOU) CO LTD
GUANGZHOU CHINA
(AN AFFI LIATE OF BAXTER WORLD TRADE INC USA)
HK-42531
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

Dianeal Representative Carton Label
Dianeal Representative Carton Label

2.5 LOW CALCIUM WITH 2.5% DEXTROSE 6000mlX2
LOT G00000000 EXP JAN 00 6AB9771E 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]SBD3
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]SBD3
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 SolutionSCD3
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 SolutionSCD3
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 SolutionSY3
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]SY3
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 SolutionSY3
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]SY3
800474Dianeal Low Calcium 1.5 % Intraperitoneal SolutionSY3
800115Dianeal Low Calcium 2.5 % Intraperitoneal SolutionSY3

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
0941-0701-01DIANEAL LOW CALCIUM WITH DEXTROSE6000 mL in 1 BAGINJECTION, SOLUTION60003
0941-0701-02DIANEAL LOW CALCIUM WITH DEXTROSE2 in 1 CARTONINJECTION, SOLUTION23
0941-0703-01DIANEAL LOW CALCIUM WITH DEXTROSE6000 mL in 1 BAGINJECTION, SOLUTION60003
0941-0703-02DIANEAL LOW CALCIUM WITH DEXTROSE2 in 1 CARTONINJECTION, SOLUTION23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0941-0701DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION [VANTIVE US HEALTHCARE LLC]3Current NDC, 2 package rows20250511_a829d4eb-3ec5-453c-b270-793969af15b3.zip
0941-0703DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION [VANTIVE US HEALTHCARE LLC]3Current NDC, 2 package rows20250511_a829d4eb-3ec5-453c-b270-793969af15b3.zip

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
0941-07010941-0701-01, 0941-0701-02
0941-07030941-0703-01, 0941-0703-02

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 LLCa829d4eb-3ec5-453c-b270-793969af15b32025-05-09Exact identifier
ndc (package): 0941-0703-01
ndc (package): 0941-0701-01
ndc (package): 0941-0703-02
ndc (package): 0941-0701-02
ndc (product): 0941-0701
ndc (product): 0941-0703
ndc11 (package): 00941070101
ndc11 (package): 00941070301
ndc11 (package): 00941070102
ndc11 (package): 00941070302
spl id: 34bf7b04-e90d-1743-e063-6294a90a4030
spl set id: a829d4eb-3ec5-453c-b270-793969af15b3

Reported adverse events (FAERS/openFDA)#

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