DIANEAL LOW CALCIUM WITH DEXTROSE
DIANEAL LOW CALCIUM WITH DEXTROSE
Approved
Approval ID
b2b780d3-26ac-4e7c-a0f2-78991bee32a8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 7, 2025
Manufacturers
FDA
Vantive US Healthcare LLC
DUNS: 119181963
Products 3
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 Code0941-0713
Product Classification
G
Generic Name
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Product Specifications
Route of AdministrationINTRAPERITONEAL
Effective DateMay 7, 2025
FDA Product Classification
INGREDIENTS (6)
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
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 chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0941-0715
Product Classification
G
Generic Name
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Product Specifications
Route of AdministrationINTRAPERITONEAL
Effective DateMay 7, 2025
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: 4.25 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: 18.3 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 Code0941-0711
Product Classification
G
Generic Name
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Product Specifications
Route of AdministrationINTRAPERITONEAL
Effective DateMay 7, 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: 18.3 mg in 100 mL
Code: M4I0D6VV5M
Classification: ACTIB
MAGNESIUM CHLORIDEActive
Quantity: 5.08 mg in 100 mL
Code: 02F3473H9O
Classification: ACTIB