Last Updated: September 24, 2026

Details for New Drug Application (NDA): 218469


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NDA 218469 describes SODIUM ACETATE, which is a drug marketed by Amneal, Extrovis, Fresenius Kabi Usa, Hikma, Hospira, Milla Pharms, and Somerset Theraps Llc, and is included in seven NDAs. It is available from six suppliers. Additional details are available on the SODIUM ACETATE profile page.

The generic ingredient in SODIUM ACETATE is sodium acetate. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the sodium acetate profile page.
Summary for 218469
Tradename:SODIUM ACETATE
Applicant:Amneal
Ingredient:sodium acetate
Patents:0
Suppliers and Packaging for NDA: 218469
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM ACETATE sodium acetate SOLUTION;INTRAVENOUS 218469 ANDA Amneal Pharmaceuticals Private Limited 80830-2435 80830-2435-2 25 BOTTLE, PLASTIC in 1 CARTON (80830-2435-2) / 20 mL in 1 BOTTLE, PLASTIC (80830-2435-1)
SODIUM ACETATE sodium acetate SOLUTION;INTRAVENOUS 218469 ANDA Amneal Pharmaceuticals Private Limited 80830-2436 80830-2436-2 25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (80830-2436-2) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (80830-2436-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength100MEQ/50ML (2MEQ/ML)
Approval Date:Aug 8, 2025TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength200MEQ/100ML (2MEQ/ML)
Approval Date:Aug 8, 2025TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength40MEQ/20ML (2MEQ/ML)
Approval Date:Mar 2, 2026TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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