Last Updated: September 24, 2026

Details for New Drug Application (NDA): 216920


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NDA 216920 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 216920
Tradename:SODIUM ACETATE
Applicant:Hikma
Ingredient:sodium acetate
Patents:0
Pharmacology for NDA: 216920
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Large Intestinal Motility
Inhibition Large Intestine Fluid/Electrolyte Absorption
Suppliers and Packaging for NDA: 216920
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM ACETATE sodium acetate SOLUTION;INTRAVENOUS 216920 ANDA Hikma Pharmaceuticals USA Inc. 0641-6261 0641-6261-01 1 VIAL in 1 CARTON (0641-6261-01) / 20 mL in 1 VIAL
SODIUM ACETATE sodium acetate SOLUTION;INTRAVENOUS 216920 ANDA Hikma Pharmaceuticals USA Inc. 0641-6262 0641-6262-01 1 VIAL in 1 CARTON (0641-6262-01) / 50 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength40MEQ/20ML (2MEQ/ML)
Approval Date:Mar 15, 2024TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength100MEQ/50ML (2MEQ/ML)
Approval Date:Mar 15, 2024TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength200MEQ/100ML (2MEQ/ML)
Approval Date:Mar 15, 2024TE:APRLD:No

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Preferred Citation:

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