Ionosol MB and Dextrose
Ionosol MB and 5% Dextrose Injection
Approved
Approval ID
1b457b1d-0e80-4578-ba6f-dedf513fc962
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 8, 2021
Manufacturers
FDA
ICU Medical Inc.
DUNS: 118380146
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DEXTROSE MONOHYDRATE, SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, and SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0990-7372
Application NumberNDA019513
Product Classification
M
Marketing Category
C73594
G
Generic Name
DEXTROSE MONOHYDRATE, SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, and SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 8, 2021
FDA Product Classification
INGREDIENTS (8)
DEXTROSE MONOHYDRATEActive
Quantity: 5 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
SODIUM LACTATEActive
Quantity: 260 mg in 100 mL
Code: TU7HW0W0QT
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 141 mg in 100 mL
Code: 660YQ98I10
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEActive
Quantity: 25 mg in 100 mL
Code: 593YOG76RN
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MAGNESIUM CHLORIDEActive
Quantity: 30 mg in 100 mL
Code: 02F3473H9O
Classification: ACTIB
MONOBASIC POTASSIUM PHOSPHATEActive
Quantity: 15 mg in 100 mL
Code: 4J9FJ0HL51
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT