Label: EXTRANEAL- icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride injection, solution
- NDC Code(s): 0941-0707-03, 0941-0707-08
- Packager: Baxter Healthcare Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Unapproved drug for use in drug shortage
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.
Drug Label Information
Updated December 16, 2024
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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, MALAYSIAAMBU-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 06021264AZLOT:
barcodeBarcode
18806466013115LOT: S24A12345 EXP: 12.12.2024
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INGREDIENTS AND APPEARANCE
EXTRANEAL
icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride injection, solutionProduct 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 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 Labeler - Baxter Healthcare Corporation (005083209) 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)
