DIANEAL PD-2 with Dextrose
These highlights do not include all the information needed to use DIANEAL peritoneal dialysis solutions safely and effectively. See full prescribing information for DIANEAL solutions DIANEAL (dextrose) peritoneal dialysis solutionInitial U.S. Approval: 1981DIANEAL PD-2 (dextrose) peritoneal dialysis solutionInitial U.S. Approval: 1992DIANEAL LOW CALCIUM (dextrose) peritoneal dialysis solutionInitial U.S. Approval: 1992
Approved
Approval ID
aa268d3f-7389-4f25-801f-5d4825495f08
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 21, 2019
Manufacturers
FDA
Baxter Healthcare Corporation
DUNS: 005083209
Products 10
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0941-0429
Application NumberNDA020163
Product Classification
M
Marketing Category
C73594
G
Generic Name
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Product Specifications
Route of AdministrationINTRAPERITONEAL
Effective DateNovember 21, 2019
FDA Product Classification
INGREDIENTS (6)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEActive
Quantity: 538 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
SODIUM LACTATEActive
Quantity: 448 mg in 100 mL
Code: TU7HW0W0QT
Classification: ACTIB
DEXTROSE MONOHYDRATEActive
Quantity: 4.25 g in 100 mL
Code: LX22YL083G
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
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0941-0415
Application NumberNDA017512
Product Classification
M
Marketing Category
C73594
G
Generic Name
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Product Specifications
Route of AdministrationINTRAPERITONEAL
Effective DateNovember 21, 2019
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEActive
Quantity: 538 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
DEXTROSE MONOHYDRATEActive
Quantity: 4.25 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
CALCIUM CHLORIDEActive
Quantity: 25.7 mg in 100 mL
Code: M4I0D6VV5M
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MAGNESIUM CHLORIDEActive
Quantity: 5.08 mg in 100 mL
Code: 02F3473H9O
Classification: ACTIB
SODIUM LACTATEActive
Quantity: 448 mg in 100 mL
Code: TU7HW0W0QT
Classification: ACTIB
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0941-0424
Application NumberNDA020183
Product Classification
M
Marketing Category
C73594
G
Generic Name
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Product Specifications
Route of AdministrationINTRAPERITONEAL
Effective DateNovember 21, 2019
FDA Product Classification
INGREDIENTS (6)
DEXTROSE MONOHYDRATEActive
Quantity: 1.5 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
SODIUM LACTATEActive
Quantity: 448 mg in 100 mL
Code: TU7HW0W0QT
Classification: ACTIB
MAGNESIUM CHLORIDEActive
Quantity: 5.08 mg in 100 mL
Code: 02F3473H9O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CALCIUM CHLORIDEActive
Quantity: 18.3 mg in 100 mL
Code: M4I0D6VV5M
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 538 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0941-0433
Application NumberNDA020183
Product Classification
M
Marketing Category
C73594
G
Generic Name
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Product Specifications
Route of AdministrationINTRAPERITONEAL
Effective DateNovember 21, 2019
FDA Product Classification
INGREDIENTS (6)
DEXTROSE MONOHYDRATEActive
Quantity: 4.25 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 538 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
CALCIUM CHLORIDEActive
Quantity: 18.3 mg in 100 mL
Code: M4I0D6VV5M
Classification: ACTIB
MAGNESIUM CHLORIDEActive
Quantity: 5.08 mg in 100 mL
Code: 02F3473H9O
Classification: ACTIB
SODIUM LACTATEActive
Quantity: 448 mg in 100 mL
Code: TU7HW0W0QT
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0941-0413
Application NumberNDA017512
Product Classification
M
Marketing Category
C73594
G
Generic Name
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Product Specifications
Route of AdministrationINTRAPERITONEAL
Effective DateNovember 21, 2019
FDA Product Classification
INGREDIENTS (6)
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
DEXTROSE MONOHYDRATEActive
Quantity: 2.5 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 538 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
SODIUM LACTATEActive
Quantity: 448 mg in 100 mL
Code: TU7HW0W0QT
Classification: ACTIB
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0941-0411
Application NumberNDA017512
Product Classification
M
Marketing Category
C73594
G
Generic Name
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Product Specifications
Route of AdministrationINTRAPERITONEAL
Effective DateNovember 21, 2019
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM CHLORIDEActive
Quantity: 5.08 mg in 100 mL
Code: 02F3473H9O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DEXTROSE MONOHYDRATEActive
Quantity: 1.5 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 538 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
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0941-0426
Application NumberNDA020163
Product Classification
M
Marketing Category
C73594
G
Generic Name
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Product Specifications
Route of AdministrationINTRAPERITONEAL
Effective DateNovember 21, 2019
FDA Product Classification
INGREDIENTS (6)
DEXTROSE MONOHYDRATEActive
Quantity: 1.5 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 538 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
SODIUM LACTATEActive
Quantity: 448 mg in 100 mL
Code: TU7HW0W0QT
Classification: ACTIB
MAGNESIUM CHLORIDEActive
Quantity: 5.08 mg in 100 mL
Code: 02F3473H9O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CALCIUM CHLORIDEActive
Quantity: 25.7 mg in 100 mL
Code: M4I0D6VV5M
Classification: ACTIB
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0941-0487
Application NumberNDA017512
Product Classification
M
Marketing Category
C73594
G
Generic Name
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Product Specifications
Route of AdministrationINTRAPERITONEAL
Effective DateNovember 21, 2019
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEActive
Quantity: 538 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
SODIUM LACTATEActive
Quantity: 448 mg in 100 mL
Code: TU7HW0W0QT
Classification: ACTIB
CALCIUM CHLORIDEActive
Quantity: 18.4 mg in 100 mL
Code: M4I0D6VV5M
Classification: ACTIB
DEXTROSE MONOHYDRATEActive
Quantity: 2.5 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
MAGNESIUM CHLORIDEActive
Quantity: 5.08 mg in 100 mL
Code: 02F3473H9O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0941-0457
Application NumberNDA017512
Product Classification
M
Marketing Category
C73594
G
Generic Name
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Product Specifications
Route of AdministrationINTRAPERITONEAL
Effective DateNovember 21, 2019
FDA Product Classification
INGREDIENTS (6)
SODIUM LACTATEActive
Quantity: 448 mg in 100 mL
Code: TU7HW0W0QT
Classification: ACTIB
CALCIUM CHLORIDEActive
Quantity: 18.3 mg in 100 mL
Code: M4I0D6VV5M
Classification: ACTIB
DEXTROSE MONOHYDRATEActive
Quantity: 2.5 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 538 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
MAGNESIUM CHLORIDEActive
Quantity: 5.08 mg in 100 mL
Code: 02F3473H9O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0941-0484
Application NumberNDA017512
Product Classification
M
Marketing Category
C73594
G
Generic Name
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Product Specifications
Route of AdministrationINTRAPERITONEAL
Effective DateNovember 21, 2019
FDA Product Classification
INGREDIENTS (6)
DEXTROSE MONOHYDRATEActive
Quantity: 1.5 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
SODIUM LACTATEActive
Quantity: 448 mg in 100 mL
Code: TU7HW0W0QT
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 538 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
CALCIUM CHLORIDEActive
Quantity: 18.4 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