EXTRANEAL Peritoneal Dialysis Solution with 7.5% Icodextrin

EXTRANEAL by

Drug Labeling and Warnings

EXTRANEAL by is a Prescription medication manufactured, distributed, or labeled by Vantive US Healthcare LLC, Vantive Manufacturing Pte. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EXTRANEAL- icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride injection, solution 
Vantive US Healthcare LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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EXTRANEAL Peritoneal Dialysis Solution with 7.5% Icodextrin

Health Care Provider Letter

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

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.

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

LOT:
barcode

Barcode
18806466013115

LOT: S24A12345 EXP: 12.12.2024

EXTRANEAL 
icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0941-0707
Route of Administration	INTRAPERITONEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ICODEXTRIN (UNII: 2NX48Z0A9G) (ICODEXTRIN - UNII:2NX48Z0A9G)	ICODEXTRIN	7.5 g  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	538 mg  in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT)	SODIUM LACTATE	448 mg  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)	CALCIUM CHLORIDE	25.7 mg  in 100 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	5.08 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0941-0707-08	6 in 1 CARTON	12/11/2024	05/13/2025
1	NDC: 0941-0707-03	2000 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug for use in drug shortage		12/11/2024	05/13/2025

Labeler - Vantive US Healthcare LLC (119181963)

Establishment
Name	Address	ID/FEI	Business Operations
Vantive Manufacturing Pte. Ltd.		599464843	analysis(0941-0707) , label(0941-0707) , manufacture(0941-0707) , pack(0941-0707) , sterilize(0941-0707)

Revised: 5/2025

Document Id: 34c03c8d-fcd6-dcc6-e063-6294a90a97f1

34391-3

Set id: ba547994-e2d1-450e-b10b-39264d00dc8c

Version: 3

Effective Time: 20250509