Isolyte S pH 7.4
Isolyte S pH 7.4 (Multi-Electrolyte Injection)
Approved
Approval ID
150437b6-320e-4c69-a434-2a26a1f0b2e4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 6, 2023
Manufacturers
FDA
B. Braun Medical Inc.
DUNS: 002397347
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, and POTASSIUM PHOSPHATE
PRODUCT DETAILS
NDC Product Code0264-7707
Application NumberNDA019696
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateOctober 6, 2023
Generic NameSODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, and POTASSIUM PHOSPHATE
INGREDIENTS (8)
SODIUM CHLORIDEActive
Quantity: 0.53 g in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
SODIUM ACETATEActive
Quantity: 0.37 g in 100 mL
Code: 4550K0SC9B
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 0.037 g in 100 mL
Code: 660YQ98I10
Classification: ACTIB
SODIUM PHOSPHATE, DIBASICActive
Quantity: 0.012 g in 100 mL
Code: GR686LBA74
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POTASSIUM PHOSPHATE, MONOBASICActive
Quantity: 0.00082 g in 100 mL
Code: 4J9FJ0HL51
Classification: ACTIB
SODIUM GLUCONATEActive
Quantity: 0.5 g in 100 mL
Code: R6Q3791S76
Classification: ACTIB
MAGNESIUM CHLORIDEActive
Quantity: 0.03 g in 100 mL
Code: 02F3473H9O
Classification: ACTIB