EXTRANEAL Peritoneal Dialysis Solution with 7.5% Icodextrin

Manufacturer
Vantive US Healthcare LLC | Vantive Manufacturing Pte. Ltd.
Effective date
2025-05-09
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:39:08

Label at a glance#

ProductEXTRANEAL
Active ingredientICODEXTRIN, 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
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DHCP Letter - 2
DHCP Letter - 2

DHCP Letter - 3
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DHCP Letter - 6
DHCP Letter - 6

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Extraneal Representative Carton Label
Extraneal Representative Carton Label

FNB4974 2000 mL
(APPROX 80 mL EXCESS)

BaxterLogo

EXTRANEAL Peritoneal Dialysis Solution with 7.5% lcodextrin
EACH 100 mL CONTAINS

7.5 g ICODEXTRIN 538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
25.7 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (5.0 TO 6.0)
mmol/LSODIUM 132 CALCIUM 1.75 MAGNESIUM 0.25 CHLORIDE 96 LACTATE 40
OSMOLARITY284 mOsmol/L (CALC)
STERILE NONPYROGENIC STORE BELOW 30°C SEE INSERT
FOR INTRAPERITONEAL ADMINISTRATION ONLY NOT FOR INTRAVENOUS USE
CAUTIONS SQUEEZE 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
MANUFACTURED BY
BAXTER HEALTHCARE SA, SINGAPORE BRANCH
2 WOODLANDS INDUSTRIAL PARK D STREET 2 SINGAPORE 737778
(AN AFFILIATE OF BAXTER HEALTHCARE CORPORATION USA)
DIRECTION TO BE USED AS DIRECTED BY PHYSICIAN
FOR HONG KONG ONLY: PRESCRIPTION DRUG
IMPORTED BY BAXTER HEALTHCARE (THAILAND) CO., LTD., BANGKOK
FOR MALAYSIA ONLY: CONTROLLED MEDICINE. JAUHI DARIPADA KANAK-KANAK
PRODUCT REGISTRATION HOLDER:
BAXTER HEALTHCARE (MALAYSIA) SDN. BHD.,
B-21-3A, THE ASCENT, PARADIGM, 1, JLN SS7/26A, 47301 PJ SELANGOR, MALAYSIA

AMBU-FLEXCONTAINER PL-146
SIN11220P MAL06021264AZ
HK-46627 BRU13021011P

THAI REG. NO. 2C 16/51 (N)

EXTRANEAL, AMBU-FLEX and PL-146are trademarks of Baxter International Inc.

Extraneal Representative Carton Label
Extraneal Representative Carton Label

3A-00001
FNB4974SG
barcode
7.5% ICODEXTRIN
EXTRANEAL
6 X 2000 ML
MAL 06021264AZ

LOT:
barcode

Barcode
18806466013115

LOT: S24A12345 EXP: 12.12.2024

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0941-07070941-0707-03, 0941-0707-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
34c03c8d-fcd6-dcc6-e063-6294a90a97f1ba547994-e2d1-450e-b10b-39264d00dc8c2025-05-09Exact identifier
spl id: 34c03c8d-fcd6-dcc6-e063-6294a90a97f1
spl set id: ba547994-e2d1-450e-b10b-39264d00dc8c
EXTRANEALICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEVantive US Healthcare LLC5bf31b49-24c8-4021-98da-33a151f2fcbe2025-05-08Exact identifier
ndc (product): 0941-0707

Reported adverse events (FAERS/openFDA)#

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