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

Extraneal DHCP Letter1
Extraneal DHCP Letter2
Extraneal DHCP Letter 3
Extraneal DHCP Letter4
Extraneal DHCP Letter5
Extraneal DHCP Letter6

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Representative Extraneal Container Label - FNB4984SG - 0941-0707

FNB4984
2000 mL
(APPROX 80 mL EXCESS)

BaxterLogo

EXTRANEAL Peritoneal Dialysis Solution with 7.5% Icodextrin

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 INRAPERITONEAL 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 INDONESIA ONLY: HARUS DENGAN RESEP DOKTER
IMPORTED & MARKETED BY PT KALBE FARMA TBK, BEKSAI – INDONESIA
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

ULTRABAGCONTAINER PL-146
SIN11220P MAL06021264AZ
HK-46627 BRU15011744P
INDONESIA DKI 0915600242A1
THAI REG. NO. 2C 16/51 (N)

30

023687

2 95 28

EXTRANEAL, UL-TRABAG and PL-146are trademarks of Baxter International Inc.

Representative Extraneal Carton Label - FNB4984SG - 0941-0707

3A-00004

FNB4984SG
barcode
Lot:
barcode

7.5% ICODEXTRIN
EXTRANEAL
6 X 2000 ML
ULTRABAG MAL 06021264AZ

023687

Barcode
18806466008418

LOT: S24A12345
EXP: 12.12.2024

EXTRANEAL 
icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0941-0707
Route of AdministrationINTRAPERITONEAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ICODEXTRIN (UNII: 2NX48Z0A9G) (ICODEXTRIN - UNII:2NX48Z0A9G) ICODEXTRIN7.5 g  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE538 mg  in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT) SODIUM LACTATE448 mg  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE25.7 mg  in 100 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE5.08 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0941-0707-066 in 1 CARTON10/23/202402/12/2027
1NDC:0941-0707-012000 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug for use in drug shortage10/23/202402/12/2027
Labeler - Vantive US Healthcare LLC (119181963)
Establishment
NameAddressID/FEIBusiness Operations
Vantive Manufacturing Pte. Ltd.599464843analysis(0941-0707) , label(0941-0707) , manufacture(0941-0707) , pack(0941-0707) , sterilize(0941-0707)

Revised: 5/2025
Document Id: 34a61fbc-fcc6-a9ad-e063-6294a90a469d
Set id: 5bf31b49-24c8-4021-98da-33a151f2fcbe
Version: 4
Effective Time: 20250508
 
Vantive US Healthcare LLC