Health Care Provider Letter
DIANEAL LOW CALCIUM WITH DEXTROSE
- Manufacturer
- Vantive US Healthcare LLC | Vantive Manufacturing Pte. Ltd.
- Effective date
- 2025-05-09
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-05-31 21:33:04
Label at a glance#
ProductDIANEAL LOW CALCIUM WITH DEXTROSE
Active ingredientDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE
Label structure2 sections
Label contents#
Full prescribing information#
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
FNB5203
5000 mL
BaxterLogo
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal
Dialysis Solution with 4.25% Dextrose
EACH 100 mL CONTAINS 4.25 g DEXTROSE HYDROUS USP 538 mg SODIUM CHLORIDE USP
448 mg SODIUM LACTATE 18.3 mg CALCIUM CHLORIDE USP
5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (4.0 to 6.5)
mEq/L SODIUM 132 CALCIUM 2.5 MAGNESIUM 0.5 CHLORIDE 95 LACTATE 40
OSMOLARITY 483 mOsmol/L (CALC)
STERILE NONPYROGENIC STORE BELOW 30°C SEE INSERT
POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN
WARNING
EXTENSIVE USE OF THIS SOLUTION DURING ONE PERITONEAL DIALYSIS PROCEDURE
CAN RESULT IN SIGNIFICANT REMOVAL OF WATER FROM THE PATIENT
FOR INTRAPERITONEAL ADMINISTRATION ONLY
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
BAXTER HEALTHCARE SA, SINGAPORE BRANCH AMBU-FLEXCONTAINER PL-146
2 WOODLANDS INDUSTRIAL PARK D STREET 2 SINGAPORE 737778
(AN AFFLIATE OF BAXTER HEALTHCARE CORPORATION USA)
SINGAPORE SIN6625P THAILAND 2C65/45 PHILIPPINES DR-XY20804 BRUNEI BRU12120968NP
HONG KONG HK-35010 VIETNAM VN-21179-18 MALAYSIA MAL09062144AZ
BAXTER HEALTHCARE (MALAYSIA) SDN, BHD.
B-21-3A, THE ASCENT, PARADIGM, 1, JLN SS7/26A,47301 PJ, SELANGOR
DIRECTIONS TO BE USED AS DIRECTED BY PHYSICIAN
JAUHI DARIPADA KANAK-KANAK
Controlled medicine/Ubat terkawal
Baxter Healthcare SA, Singapore Branch
10 5 TEL 6262-7100
DIANEAL, AMBU-FLEX & PL-146are trademarks of Baxter International Inc.
PVCsymbol
3A-00004
FNB5203GN
4.25% DEX
DIANEAL LOW CALCIUM PD-4
2 X 5000 ML
MAL 09062144AZ
Barcode
Lot:
Barcode
4.25%
(2.5mEq/L)
022298
Barcode
18806101552030
LOT: S24A12345 EXP: 12.12.2024
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 800074 | calcium chloride 0.000996 MEQ/ML / glucose 1.7 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal Low Calcium 4.25] | SBD | 4 |
| 800066 | calcium chloride 0.000996 MEQ/ML / glucose 1.7 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution | SCD | 4 |
| 800066 | Calcium Chloride 0.000996 MEQ/ML / Glucose 1.7 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution | SY | 4 |
| 800074 | Calcium Chloride 0.000996 MEQ/ML / Glucose 1.7 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal Low Calcium 4.25] | SY | 4 |
| 800074 | Dianeal Low Calcium 4.25 % 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 |
|---|---|---|---|---|---|---|
| 0941-0705-01 | DIANEAL LOW CALCIUM WITH DEXTROSE | 5000 mL in 1 BAG | INJECTION, SOLUTION | 5000 | 4 | |
| 0941-0705-02 | DIANEAL LOW CALCIUM WITH DEXTROSE | 2 in 1 CARTON | INJECTION, SOLUTION | 2 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0941-0705 | DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION [VANTIVE US HEALTHCARE LLC] | 4 | Current NDC, 2 package rows | 20250511_67bee807-7ba8-4e92-81f2-c888118d277e.zip |
Products#
Every source-derived product name is available through these pages.
- DIANEAL LOW CALCIUM WITH DEXTROSE
- sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
- WATER
- DEXTROSE MONOHYDRATE
- ANHYDROUS DEXTROSE
- 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 |
|---|---|
| 0941-0705 | 0941-0705-01, 0941-0705-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| DEXTROSE MONOHYDRATE | LX22YL083G | 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 |
|---|---|---|---|---|---|---|
| DIANEAL LOW CALCIUM WITH DEXTROSE | SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE | Vantive US Healthcare LLC | 67bee807-7ba8-4e92-81f2-c888118d277e | 2025-05-09 | 0941-0705-02 0941-0705-01 0941-0705 00941070501 00941070502 34bdf7f0-3fd3-e998-e063-6394a90a9855 67bee807-7ba8-4e92-81f2-c888118d277e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.