Active substance
Sodium acetate
- US FDA 7
- Health Canada 2
- Safety 4
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| SODIUM ACETATE | 40MEQ/20ML (2MEQ/ML); 100MEQ/50ML (2MEQ/ML); 200MEQ/100ML (2MEQ/ML) | solution · intravenous | HOSPIRA | Prescription | 4 May 1983 |
| SODIUM ACETATE | 400MEQ/100ML (4MEQ/ML) | solution · intravenous | FRESENIUS KABI USA | Prescription | 30 Oct 2017 |
| SODIUM ACETATE | 100MEQ/50ML (2MEQ/ML); 400MEQ/100ML (4MEQ/ML); 200MEQ/100ML (2MEQ/ML); 40MEQ/20ML (2MEQ/ML) | solution · intravenous | MILLA PHARMS | Prescription | 4 May 2021 |
| SODIUM ACETATE | 40MEQ/20ML (2MEQ/ML); 100MEQ/50ML (2MEQ/ML); 200MEQ/100ML (2MEQ/ML) | solution · intravenous | HIKMA | Prescription | 15 Mar 2024 |
| SODIUM ACETATE | 100MEQ/50ML (2MEQ/ML); 200MEQ/100ML (2MEQ/ML); 40MEQ/20ML (2MEQ/ML) | solution · intravenous | AMNEAL | Prescription | 8 Aug 2025 |
| SODIUM ACETATE | 100MEQ/50ML (2MEQ/ML); 200MEQ/100ML (2MEQ/ML) | solution · intravenous | SOMERSET THERAPS LLC | Prescription | 18 Sep 2025 |
| SODIUM ACETATE | 100MEQ/50ML (2MEQ/ML); 200MEQ/100ML (2MEQ/ML) | solution · intravenous | DR REDDYS | Prescription | 17 Apr 2026 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| SODIUM ACETATE INJECTION USP | 02181746 | 328 MG / ML | SOLUTION · INTRAVENOUS | OMEGA LABORATORIES LIMITED |
| SODIUM ACETATE INJECTION, USP | 02139529 | 328 MG / ML | SOLUTION · INTRAVENOUS | FRESENIUS KABI CANADA LTD |
Safety signals and safety-related labeling changes
- US FDA 24 Jul 2025 KABIVEN IN PLASTIC CONTAINER — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 24 Jul 2025 PERIKABIVEN IN PLASTIC CONTAINER — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 5 Aug 2019 PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations - US FDA 5 Aug 2019 PLASMA-LYTE A IN PLASTIC CONTAINER — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations
Combinations containing Sodium acetate
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.