SODIUM ACETATE INJECTION, USP 200 mEq/100 mL (2 mEq/mL)

Sodium Acetate by

Drug Labeling and Warnings

Sodium Acetate by is a Prescription medication manufactured, distributed, or labeled by Exela Pharma Sciences, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SODIUM ACETATE- sodium acetate injection, solution 
Exela Pharma Sciences, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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SODIUM ACETATE INJECTION, USP 200 mEq/100 mL (2 mEq/mL)

DOSAGE AND ADMINISTRATION

Sodium Acetate Injection, USP (2 mEq/mL) is administered intravenously only after dilution in a larger volume of fluid. The dose and rate of administration are dependent upon the individual needs of the patient. Serum sodium should be monitored as a guide to dosage. Using aseptic technique, all or part of the contents of one or more vials may be added to other intravenous fluids to provide any desired number of milliequivalents (mEq) of sodium (Na+) with an equal number of acetate (CH3COO−).

Sodium Acetate Injection, USP (2 mEq/mL) in the Pharmacy Bulk Package is designed for use with manual, gravity flow operations and automated compounding devices for preparing intravenous nutritional admixtures. Admixtures must be stored under refrigeration and used within 24 hours after compounding.

A single entry through the vial closure should be made with a sterile dispensing set or transfer device. Transfer individual doses to appropriate intravenous infusion solutions. Use of a syringe with a needle is not recommended. The above process should be carried out under a laminar flow hood using aseptic technique.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

SODIUM ACETATE INJECTION, USP

NDC: 51754-9995-1

200 mEq/100 mL (2 mEq/mL) Rx Only

Pharmacy Bulk Package. Not for Direct Infusion.

CAUTION: MUST BE DILUTED

FOR INTRAVENOUS USE ONLY. PRESERVATIVE FREE.

Sterile, Nonpyrogenic Use only if solution is clear and seal is intact.

Volume: 100 mL/Vial

SODIUM ACETATE 
sodium acetate injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 51754-9995
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM ACETATE ANHYDROUS (UNII: NVG71ZZ7P0) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM ACETATE ANHYDROUS	200 meq  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51754-9995-5	20 in 1 CARTON	07/01/2022
1	NDC: 51754-9995-1	100 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		07/01/2022	07/01/2022

Labeler - Exela Pharma Sciences, LLC (831274399)

Establishment
Name	Address	ID/FEI	Business Operations
Exela Pharma Sciences, LLC		831274399	MANUFACTURE(51754-9995) , PACK(51754-9995) , LABEL(51754-9995)

Revised: 6/2022

Document Id: 811e32a7-df1a-485d-8ac8-5bc92223890e

34391-3

Set id: e11ab1a1-8cc7-4d3b-ad29-af4c9aaa3ed4

Version: 2

Effective Time: 20220616