DIANEAL LOW CALCIUM WITH DEXTROSE

Manufacturer
Vantive US Healthcare LLC | Baxter Manufacturing (Thailand) Co., Ltd
Effective date
2025-05-07
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 21:32:57

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 1
Dianeal DHCP 1
Dianeal - DHCP 2
Dianeal - DHCP 2
Dianeal - DHCP 3
Dianeal - DHCP 3
Dianeal - DHCP 4
Dianeal - DHCP 4
Dianeal - DHCP 5
Dianeal - DHCP 5
Dianeal - DHCP 6
Dianeal - DHCP 6
Dianeal - DHCP 7
Dianeal - DHCP 7
Dianeal - DHCP 8
Dianeal - DHCP 8

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dianeal Representative Container Label THB9766 - 0941-0711.jpg
Dianeal Representative Container Label THB9766 - 0941-0711.jpg

BaxterLogo
THB9766
2000 ml

Dianeal® PD-4 Low Calcium
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 (4.0 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

KEEP OUT OF REACH OF CHILDREN

AVOID EXCESSIVE HEAT SEE INSERT
INDICATED FOR CHRONIC RENAL FAILURE PATIENTS
BEING MAINTAINED ON PERITONEAL DIALYSIS

DIRECTIONTO BE USED AS DIRECTED BY THE PHYSICIAN

STORAGEBELOW 30°C
REG NO.2A 12/59
THRS1107
BH Symbol
MANUFACTURED BY:
BAXTER MANUFACTURING (THAILAND) CO. LTD.
RAYONG, THAILAND

Dianeal Representative Carton Label THB9766 - 0941-0711
Dianeal Representative Carton Label THB9766 - 0941-0711

PD-4
1.5%

Dianeal PD-4 Low Calcium with 1.5% Dextrose
THB9766
6 X 2000 mL

Each 100 ml contains
Dextrose Hydrous USP 1.5 g
Sodium Chloride USP 538 mg
Sodium Lactate 448 mg
Calcium Chloride USP 18.3 mg
Magnesium Chloride USP 5.08 mg
pH 5.2 (4.0-6.5)

Reg No. 2A 12/59

Manufacturing by
Baxter Manufacturing (Thailand) Co., Ltd.
Rayong, Thailand

Sterile, Nonpyrogenic Solution
Store below 30°C

Batch No. A20A007
MFD. 7 Jan 2020
EXP. 7 Jan 2022

Barcode
00002

(01)50085412528217(10)A20A007(17)220107

Dianeal Representative Container Label THB9776
Dianeal Representative Container Label THB9776

BaxterLogo
THB9776
2000 ml

Dianeal® PD-4 Low Calcium
with 2.5% Dextrose

EACH 100 ml CONTAINS2.5 g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 18.3 mg
CALCIUM CHLORIDE DIHYDRATE USP 5.08 mg MAGNESIUM
CHLORIDE HEXAHYDRATE USP pH5.2 (4.0 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 KEEP OUT OF REACH OF CHILDREN

AVOID EXCESSIVE HEAT SEE INSERT
INDICATED FOR CHRONIC RENAL FAILURE PATIENTS
BEING MAINTAINED ON PERITONEAL DIALYSIS

DIRECTIONTO BE USED AS DIRECTED BY THE PHYSICIAN
STORAGEBELOW 30°C

REG NO.2A 95/59
THRS1109
BG Symbol

MANUFACTURED BY:
BAXTER MANUFACTURING (THAILAND) CO. LTD.
RAYONG, THAILAND

Dianeal Representative Carton Label THB9776
Dianeal Representative Carton Label THB9776

PD-4
2.5%

Dianeal PD-4 Low Calcium with 2.5% Dextrose
THB9776
6 X 2000 mL

Each 100 ml contains
Dextrose Hydrous USP 2.5 g
Sodium Chloride USP 538 mg
Sodium Lactate 448 mg
Calcium Chloride Dihydrate USP 18.3 mg
Magnesium Chloride Hexahydrate USP 5.08 mg

pH 5.2 (4.0-6.5)

Reg No. 2A 95/59

Manufacturing by
Baxter Manufacturing (Thailand) Co., Ltd.
Rayong, Thailand

Sterile, Nonpyrogenic Solution
Store below 30°C

Batch No. A20A023
MFD. 10 Jan 2020
EXP. 10 Jan 2022

Barcode
00001

(01)500854 12528224(10)A20A023(17)220110

Dianeal Representative Container Label THB9796IP
Dianeal Representative Container Label THB9796IP

BaxterLogo
THB9796IP
2000 ml

Peritoneal Dialysis Solution Low Calcium with
4.5% Dextrose-IP
Dianeal® PD-4 Low Calcium

EACH 100 ml CONTAINS4.25 g DEXTROSE HYDROUS 538 mg SODIUM CHLORIDE
448 mg SODIUM LACTATE 18.3 mg CALCIUM CHLORIDE DIHYDRATE 5.08 mg
MAGNESIUM CHLORIDE HEXAHYDRATE pH5.2 (4.5 to 6.5) mEq/L
SODIUM 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

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
KEEP OUT OF REACH OF CHILDREN AVOID EXCESSIVE HEAT
INDICATED FOR CHRONIC RENAL FAILURE PATIENTS
BEING MAINTAINED ON PERITONEAL DIALYSIS

INDICATION/ADMINISTRATION AND COMPLETE INFORMATION –REFER PACKAGE INSERT

STORAGEBELOW 30°C
THA REG NO.2A 93/59
THRS1131
AA Symbol

NAME AND ADDRESS OF MANUFACTURER:
BAXTER MANUFACTURING (THAILAND) CO., LTD.
7/398 MOO 6 MABYANGPORN, PLUAKDAENG, RAYONG, THAILAND 21140

Name and Address of Importer:
Baxter (India) Pvt. Ltd., No. 219-1A, 1B,225/4B, Block C, Ground Floor,
Kothari ware house, Opposite to Vegetarian Village, Madhavaram
Red Hills Road Puzhal village, Ambattur Taluk, Tiruvallur District,
Chennai – 600060 Tamil Nadu, India

Import License Number:IL/FF-000400 RC/FF-002173

Telephone no., email address (in case of consumer complaint, Safety Reporting or Queries):
Consumer Care No.: 0124-4603200
Consumer Care email ID: Customerservice_SHS_India@baxter.com

Dianeal Representative Carton Label THB9796IP
Dianeal Representative Carton Label THB9796IP

PEITONEAL DIALYSIS SOLUTION LOW
CALCIUM WITH 4.25% DEXTROSE-IP

PD-4
4.25%
DEXTROSE

(Dianeal® PD-4)
THB9796IP

Each 100 ml contains
Dextrose Hydrous 4.25 g
Sodium Chloride 538 mg
Sodium Lactate 448 mg
Calcium Chloride Dihydrate 18.3 mg
Magnesium Chloride Hexahydrate 5.08 mg

pH 5.2 (4.5-6.5)

Manufactured by
BAXTER MANUFACTURING (THAILAND) CO., LTD.,
7/398 MOO 6 MABYANGPORN, PLUAKDAENG,
RAYONG, THAILAND, 21140
NAME AND ADDRESS OF IMPORTER:
Baxter (India) Pvt. Ltd. No. 219-1A, 1B,225/4B, Block C,
Ground Floor, Kothari ware house, Opposite to Vegetarian Village,
Madhavaran Red Hills Road Puzhal village, Ambattur Taluk,
Tiruvallur District, Chennai – 600060 TAMILNADU, India

IMPORT LICENSE NUMBER: IL/FF-000400 RC/RF-002173

Sterile, Nonpyrogenic Solution
Store below 30°C

Batch No. A99A999
MFD. 99 Mar 9999
EXP. 99 Mar 9999

MRP Rs. 9999.99(incl. of all taxes)
Net Quality – 6 U X 2000 mL.

NAME, ADDRESS, TELEPHONE NO., EMAIL ADDRESS
(IN CASE OF CONSUMER COMPLAINT, SAFETY REPORTING OR QUERIES):
Baxter (India) Private Limited, 5 thFloor, Tower A, Building No. 9,
DLF Cyber City, DLF Phase III, Gurgaon – 122002/ Haryana, India
Consumer Care No.: 0124-4603200
Consumer Care email ID: Customerservice_SHS_India@baxter.com
Rev.01

Barcode
00001

(01)8859656197969(10)X21SXXX(17)231120

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
0941-0711-01DIANEAL LOW CALCIUM WITH DEXTROSE2000 mL in 1 BAGINJECTION, SOLUTION20004
0941-0711-06DIANEAL LOW CALCIUM WITH DEXTROSE6 in 1 CARTONINJECTION, SOLUTION64
0941-0713-01DIANEAL LOW CALCIUM WITH DEXTROSE2000 mL in 1 BAGINJECTION, SOLUTION20004
0941-0713-06DIANEAL LOW CALCIUM WITH DEXTROSE6 in 1 CARTONINJECTION, SOLUTION64
0941-0715-01DIANEAL LOW CALCIUM WITH DEXTROSE2000 mL in 1 BAGINJECTION, SOLUTION20004
0941-0715-06DIANEAL LOW CALCIUM WITH DEXTROSE6 in 1 CARTONINJECTION, SOLUTION64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0941-0711DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION [VANTIVE US HEALTHCARE LLC]4Current NDC, 2 package rows20250508_b2b780d3-26ac-4e7c-a0f2-78991bee32a8.zip
0941-0713DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION [VANTIVE US HEALTHCARE LLC]4Current NDC, 2 package rows20250508_b2b780d3-26ac-4e7c-a0f2-78991bee32a8.zip
0941-0715DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION [VANTIVE US HEALTHCARE LLC]42 package rows20250508_b2b780d3-26ac-4e7c-a0f2-78991bee32a8.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 LLCb2b780d3-26ac-4e7c-a0f2-78991bee32a82025-05-07Exact identifier
ndc (package): 0941-0713-06
ndc (package): 0941-0715-06
ndc (package): 0941-0715-01
ndc (package): 0941-0711-01
ndc (package): 0941-0711-06
ndc (package): 0941-0713-01
ndc (product): 0941-0711
ndc (product): 0941-0713
ndc (product): 0941-0715
ndc11 (package): 00941071506
ndc11 (package): 00941071101
ndc11 (package): 00941071501
ndc11 (package): 00941071301
ndc11 (package): 00941071106
ndc11 (package): 00941071306
spl id: 348e5f59-47cf-e98e-e063-6394a90a33cd
spl set id: b2b780d3-26ac-4e7c-a0f2-78991bee32a8

Reported adverse events (FAERS/openFDA)#

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