Isolyte S
Isolyte S(Multi-Electrolyte Injection)
Approved
Approval ID
7e8fe27f-ff82-48c1-9bf6-3c589c8e985d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 14, 2020
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, and MAGNESIUM CHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0264-7703
Application NumberNDA019711
Product Classification
M
Marketing Category
C73594
G
Generic Name
SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 17, 2018
FDA Product Classification
INGREDIENTS (6)
SODIUM GLUCONATEActive
Quantity: 0.5 g in 100 mL
Code: R6Q3791S76
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 0.037 g in 100 mL
Code: 660YQ98I10
Classification: ACTIB
SODIUM ACETATEActive
Quantity: 0.37 g in 100 mL
Code: 4550K0SC9B
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 0.53 g in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
MAGNESIUM CHLORIDEActive
Quantity: 0.03 g in 100 mL
Code: 02F3473H9O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT