NORMOSOL-M AND DEXTROSE
NORMOSOL™-M and 5% DEXTROSE InjectionMULTIPLE ELECTROLYTES AND 5% DEXTROSE INJECTION TYPE 1, USP
Approved
Approval ID
aba60c84-94d9-46d0-bdbb-25e0c4e8cc41
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 13, 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 chloride, potassium acetate, and magnesium acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0990-7965
Application NumberNDA017610
Product Classification
M
Marketing Category
C73594
G
Generic Name
dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 13, 2021
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEActive
Quantity: 234 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
MAGNESIUM ACETATEActive
Quantity: 21 mg in 100 mL
Code: 0E95JZY48K
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DEXTROSE MONOHYDRATEActive
Quantity: 5 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
POTASSIUM ACETATEActive
Quantity: 128 mg in 100 mL
Code: M911911U02
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT