FDA.reportPublic FDA data

DIANEAL PD-2 Dialysis Solution with 1.5% 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
legacy-cache
Hydrated at
2026-08-01 20:39:09

Label at a glance#

ProductDIANEAL PD-2 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

DHCP Letter - 1
DHCP Letter - 1
DHCP Letter - 2
DHCP Letter - 2
DHCP Letter - 3
DHCP Letter - 3
DHCP Letter - 4
DHCP Letter - 4
DHCP Letter - 5
DHCP Letter - 5
DHCP Letter - 6
DHCP Letter - 6

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dianeal Representative Container Label
Dianeal Representative Container Label

6AB5166E 2000ml
(APPROX 80ml EXCESS)

Baxter Logo

Dianeal ®PD-2
Peritoneal Dialysis Solution
With 1.5% Dextrose

EACH 100ml CONTAINS1.5 g DEXTROSE HYDROUS USP 538 mg
SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 25.7 mg CALCIUM
CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH5 .2 (4 .5 to 6 .5)
mEq/LSODIUM 132 CALCIUM 3.5 MAGNESIUM 0.5 CHLORIDE 96
LACTATE 40  OSMOLARITY346 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 AFFILIATE OF BAXTER WORLD TRADE INC USA)

HK-42544

DIRECTIONSTO BE USED AS DIRECTED BY THE PHYSICIAN

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

Dianeal Representative Carton Label
Dianeal Representative Carton Label

1.5 PD-2 WITH 1.5% DEXTROSE 2000mlX6
LOT G00000000 EXP JAN 00

6AB5166E S/N 0000

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
0941-07370941-0737-01, 0941-0737-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
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
34c07161-2d8d-243f-e063-6294a90a5468f7ce044b-fabd-4b8b-aeca-1a024dfb66032025-05-09Exact identifier
spl id: 34c07161-2d8d-243f-e063-6294a90a5468
spl set id: f7ce044b-fabd-4b8b-aeca-1a024dfb6603

Reported adverse events (FAERS/openFDA)#

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