EXTRANEAL
EXTRANEAL Solution for Peritoneal Dialysis
Approved
Approval ID
2b327b13-a0e9-4b2c-9875-4470998e2e30
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 7, 2025
Manufacturers
FDA
Vantive US Healthcare LLC
DUNS: 119181963
Products 2
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 Code0941-0681
Product Classification
G
Generic Name
icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
Product Specifications
Route of AdministrationINTRAPERITONEAL
Effective DateMay 7, 2025
FDA Product Classification
INGREDIENTS (5)
ICODEXTRINActive
Quantity: 7.5 g in 100 mL
Code: 2NX48Z0A9G
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 540 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
SODIUM LACTATEActive
Quantity: 450 mg in 100 mL
Code: TU7HW0W0QT
Classification: ACTIB
CALCIUM CHLORIDEActive
Quantity: 25.7 mg in 100 mL
Code: M4I0D6VV5M
Classification: ACTIB
MAGNESIUM CHLORIDEActive
Quantity: 5.1 mg in 100 mL
Code: 02F3473H9O
Classification: ACTIB
icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0941-0719
Product Classification
G
Generic Name
icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
Product Specifications
Route of AdministrationINTRAPERITONEAL
Effective DateMay 7, 2025
FDA Product Classification
INGREDIENTS (5)
ICODEXTRINActive
Quantity: 7.5 g in 100 mL
Code: 2NX48Z0A9G
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 540 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
SODIUM LACTATEActive
Quantity: 450 mg in 100 mL
Code: TU7HW0W0QT
Classification: ACTIB
CALCIUM CHLORIDEActive
Quantity: 25.7 mg in 100 mL
Code: M4I0D6VV5M
Classification: ACTIB
MAGNESIUM CHLORIDEActive
Quantity: 5.1 mg in 100 mL
Code: 02F3473H9O
Classification: ACTIB