EXTRANEAL
These highlights do not include all the information needed to use EXTRANEAL safely and effectively. See full prescribing information for EXTRANEAL. EXTRANEAL (icodextrin) peritoneal dialysis solutionInitial U.S. Approval: 2002
Approved
Approval ID
d5b85158-b0d6-4855-9d07-8d1b3ad9ab71
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 24, 2020
Manufacturers
FDA
Baxter Healthcare Corporation
DUNS: 005083209
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0941-0679
Application NumberNDA021321
Product Classification
M
Marketing Category
C73594
G
Generic Name
icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
Product Specifications
Route of AdministrationINTRAPERITONEAL
Effective DateSeptember 24, 2020
FDA Product Classification
INGREDIENTS (8)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ICODEXTRINActive
Quantity: 7.5 g in 100 mL
Code: 2NX48Z0A9G
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 535 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
SODIUM LACTATEActive
Quantity: 448 mg in 100 mL
Code: TU7HW0W0QT
Classification: ACTIB
CALCIUM CHLORIDEActive
Quantity: 25.7 mg in 100 mL
Code: M4I0D6VV5M
Classification: ACTIB
MAGNESIUM CHLORIDEActive
Quantity: 5.08 mg in 100 mL
Code: 02F3473H9O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT