Health Care Provider Letter
EXTRANEAL Peritoneal Dialysis Solution with 7.5% icodextrin
- Manufacturer
- Vantive US Healthcare LLC | Vantive Manufacturing Pte. Ltd.
- Effective date
- 2025-05-08
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-05-31 21:33:02
Label at a glance#
ProductEXTRANEAL
Active ingredientICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE
Label structure2 sections
Label contents#
Full prescribing information#
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
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.
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
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1100746 | Extraneal 0.00232 MEQ/mL / 75 MG/mL / 0.000533 MEQ/mL / 0.0915 MEQ/mL / 0.04 MEQ/mL Injectable Solution | PSN | 4 |
| 1100746 | calcium chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / magnesium chloride 0.000533 MEQ/ML / sodium chloride 0.0915 MEQ/ML / sodium lactate 0.04 MEQ/ML Injectable Solution [Extraneal] | SBD | 4 |
| 1100742 | calcium chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / magnesium chloride 0.000533 MEQ/ML / sodium chloride 0.0915 MEQ/ML / sodium lactate 0.04 MEQ/ML Injectable Solution | SCD | 4 |
| 1100742 | Calcium Chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / Magnesium Chloride 0.000533 MEQ/ML / NaCl 0.0915 MEQ/ML / Sodium Lactate 0.04 MEQ/ML Injectable Solution | SY | 4 |
| 1100746 | Calcium Chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / Magnesium Chloride 0.000533 MEQ/ML / NaCl 0.0915 MEQ/ML / Sodium Lactate 0.04 MEQ/ML Injectable Solution [Extraneal] | SY | 4 |
| 1100746 | Extraneal (calcium chloride 25.7 MG / icodextrin 7.5 GM / magnesium chloride 5.08 MG / sodium chloride 535 MG / sodium lactate 448 MG) per 100 ML Intraperitoneal Solution | SY | 4 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| LACTIC ACID, UNSPECIFIED FORM Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20220121 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0941-0707-01 | EXTRANEAL | 2000 mL in 1 BAG | INJECTION, SOLUTION | 2000 | 4 | |
| 0941-0707-06 | EXTRANEAL | 6 in 1 CARTON | INJECTION, SOLUTION | 6 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0941-0707 | EXTRANEAL (ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) INJECTION, SOLUTION [VANTIVE US HEALTHCARE LLC] | 4 | Current NDC, 2 package rows | 20250510_5bf31b49-24c8-4021-98da-33a151f2fcbe.zip |
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 | 0941-0707-01, 0941-0707-06 |
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 |
|---|---|---|---|---|---|---|
| EXTRANEAL | ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Vantive US Healthcare LLC | 5bf31b49-24c8-4021-98da-33a151f2fcbe | 2025-05-08 | 0941-0707-01 0941-0707-06 0941-0707 00941070701 00941070706 34a61fbc-fcc6-a9ad-e063-6294a90a469d 5bf31b49-24c8-4021-98da-33a151f2fcbe |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.