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Potassium Chloride in Sodium Chloride

Potassium Chloride in Sodium Chloride Injection, USP

Approved
Approval ID

243fe8fc-996a-4855-8daf-069628e547c4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 16, 2023

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.

SODIUM CHLORIDE and POTASSIUM CHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0990-9257
Application NumberANDA078446
Product Classification
M
Marketing Category
C73584
G
Generic Name
SODIUM CHLORIDE and POTASSIUM CHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 16, 2023
FDA Product Classification

INGREDIENTS (2)

SODIUM CHLORIDEActive
Quantity: 4.5 g in 1000 mL
Code: 451W47IQ8X
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 1.49 g in 1000 mL
Code: 660YQ98I10
Classification: ACTIB

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Potassium Chloride in Sodium Chloride - FDA Drug Approval Details