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Normosol-R and Dextrose

Normosol-R and 5% Dextrose Injection

Approved
Approval ID

ead1fca3-eff4-478f-8a8f-67510f80151a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 6, 2020

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, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium Chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0990-7968
Application NumberNDA017609
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium Chloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 6, 2020
FDA Product Classification

INGREDIENTS (8)

DEXTROSE, UNSPECIFIED FORMActive
Quantity: 5 g in 100 mL
Code: IY9XDZ35W2
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 526 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 37 mg in 100 mL
Code: 660YQ98I10
Classification: ACTIB
SODIUM GLUCONATEActive
Quantity: 502 mg in 100 mL
Code: R6Q3791S76
Classification: ACTIB
SODIUM ACETATE ANHYDROUSActive
Quantity: 222 mg in 100 mL
Code: NVG71ZZ7P0
Classification: ACTIB
MAGNESIUM CHLORIDEActive
Quantity: 30 mg in 100 mL
Code: 02F3473H9O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

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