Multiple Electrolytes pH 5.5
Multiple Electrolytes Injection, Type 1, USP, pH 5.5 in FREEFLEX Plastic Container
Approved
Approval ID
cf1f5f15-d31d-4a02-8f7e-b289d5ad4b5c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2022
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 013547657
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 Code65219-387
Application NumberANDA215370
Product Classification
M
Marketing Category
C73584
G
Generic Name
sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 1, 2021
FDA Product Classification
INGREDIENTS (6)
SODIUM GLUCONATEActive
Quantity: 502 mg in 100 mL
Code: R6Q3791S76
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 526 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
MAGNESIUM CHLORIDEActive
Quantity: 30 mg in 100 mL
Code: 02F3473H9O
Classification: ACTIB
SODIUM ACETATEActive
Quantity: 368 mg in 100 mL
Code: 4550K0SC9B
Classification: ACTIB
Hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
POTASSIUM CHLORIDEActive
Quantity: 37 mg in 100 mL
Code: 660YQ98I10
Classification: ACTIB