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Delflex

These highlights do not include all the information needed to use DELFLEX safely and effectively. See full prescribing information for DELFLEX peritoneal dialysis solution with attached stay•safe exchange set DELFLEX (dextrose) peritoneal dialysis solution with attached stay•safe exchange set Initial U.S. Approval: 1992

Approved
Approval ID

a98facd6-9daa-4d37-8209-63a0599dbfaa

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 24, 2025

Manufacturers
FDA

Fresenius Medical Care de Mexico, S.A. de C.V.

DUNS: 812652287

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code46163-212
Application NumberNDA020171
Product Classification
M
Marketing Category
C73594
G
Generic Name
dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
Product Specifications
Route of AdministrationINTRAPERITONEAL
Effective DateMarch 24, 2025
FDA Product Classification

INGREDIENTS (6)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
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
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
CALCIUM CHLORIDEActive
Quantity: 18.4 mg in 100 mL
Code: M4I0D6VV5M
Classification: ACTIB

dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code46163-206
Application NumberNDA020171
Product Classification
M
Marketing Category
C73594
G
Generic Name
dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
Product Specifications
Route of AdministrationINTRAPERITONEAL
Effective DateMarch 24, 2025
FDA Product Classification

INGREDIENTS (6)

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: 18.4 mg in 100 mL
Code: M4I0D6VV5M
Classification: ACTIB
MAGNESIUM CHLORIDEActive
Quantity: 5.08 mg in 100 mL
Code: 02F3473H9O
Classification: ACTIB

dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code46163-209
Application NumberNDA020171
Product Classification
M
Marketing Category
C73594
G
Generic Name
dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
Product Specifications
Route of AdministrationINTRAPERITONEAL
Effective DateMarch 24, 2025
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
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

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Delflex - FDA Drug Approval Details