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#
Label contents#
Full prescribing information#
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
Products#
Every source-derived product name is available through these pages.
- EXTRANEAL
- icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
- WATER
- HYDROCHLORIC ACID
- SODIUM HYDROXIDE
- ICODEXTRIN
- SODIUM CHLORIDE
- SODIUM CATION
- CHLORIDE ION
- SODIUM LACTATE
- LACTIC ACID, UNSPECIFIED FORM
- CALCIUM CHLORIDE
- CALCIUM CATION
- MAGNESIUM CHLORIDE
- MAGNESIUM CATION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0941-0707 | 0941-0707-03, 0941-0707-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| HYDROCHLORIC ACID | QTT17582CB | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| ICODEXTRIN | 2NX48Z0A9G | ACTIB |
| SODIUM CHLORIDE | 451W47IQ8X | ACTIB |
| SODIUM LACTATE | TU7HW0W0QT | ACTIB |
| CALCIUM CHLORIDE | M4I0D6VV5M | ACTIB |
| MAGNESIUM CHLORIDE | 02F3473H9O | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 34c03c8d-fcd6-dcc6-e063-6294a90a97f1 | ba547994-e2d1-450e-b10b-39264d00dc8c | 2025-05-09 | 34c03c8d-fcd6-dcc6-e063-6294a90a97f1 ba547994-e2d1-450e-b10b-39264d00dc8c | |||
| EXTRANEAL | ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Vantive US Healthcare LLC | 5bf31b49-24c8-4021-98da-33a151f2fcbe | 2025-05-08 | 0941-0707 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.





