Prescription medicine
Sodium acetate
Sodium acetate is a prescription medicine with an FDA approval on record since 1983. FDA's NDC Directory lists it from 5 generic labelers.
- Generic listed
- In shortage
Check it at the source: the sodium acetate FDA label on DailyMed (effective March 26, 2026, Hospira, Inc.); the NDA 18893 record on Drugs@FDA; every sodium acetate label on DailyMed.
Highlights of the record
FDA label of March 26, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageSodium Acetate Injection, USP 40 mEq is indicated as a source of sodium, for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake.
Forms and strengths
- 3.28 g/20ml
- 4 meq/100ml
- 164 mg/ml
- 200 meq/100ml
- 400 meq/100ml
Injection (solution) (concentrate); injection; solution (concentrate).
On the market
- Earliest approval on file
- May 4, 1983 Sodium Acetate, Hospira; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first October 30, 2017; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 5 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- 2 of 15 presentations limited or unavailable updated October 1, 2026
- Recalls by its makers (FDA)
- 2 since 2013 1 Class I among all firms' recalls; latest March 4, 2022
- FAERS reports
- 275 through July 30, 2026
What is sodium acetate used for?
From the label: indications and usageSodium Acetate Injection, USP 40 mEq is indicated as a source of sodium, for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.
FDA pharmacologic class: Osmotic Laxative.
Source: FDA drug label (Sodium Acetate), Hospira, Inc., effective March 26, 2026 (SPL set ce9a7469-c4ba-4f60-8f7a-47ef0974316e), via openFDA; the full label on DailyMed
Is there a generic for sodium acetate?
The FDA approved the first generic sodium acetate on October 30, 2017. 6 generic applications are approved; 6 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists sodium acetate from 5 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1983 earliest approval on file
- 2017 first generic approved
- 2016 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is sodium acetate in shortage?
The FDA Drug Shortage Database lists 2 of 15 sodium acetate presentations as limited or unavailable (updated October 1, 2026); the first entry was posted on February 3, 2016. 13 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Sodium Acetate, Injection, 100 mEq/50 mL (2 mEq/mL) (NDC 0409-3299-05) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Sodium Acetate, Injection, 100 mEq/50 mL (2 mEq/mL) (NDC 0409-3299-26) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Sodium Acetate, Injection, 100 mEq/50mL (2 mEq/mL) (NDC 0641-6262-01) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Sodium Acetate, Injection, 100 mEq/50mL (2 mEq/mL) (NDC 71357-007-10) | Milla Pharmaceuticals | Current | October 1, 2026 |
| Sodium Acetate, Injection, 164 mg/1 mL (NDC 70069-047-25) | Somerset Therapeutics, LLC | Current | September 11, 2026 |
| Sodium Acetate, Injection, 164 mg/1 mL (NDC 70069-048-20) | Somerset Therapeutics, LLC | Current | September 11, 2026 |
| Sodium Acetate, Injection, 200 mEq/100 mL (2 mEq/mL) (NDC 0409-3299-06) | Hospira, Inc., a Pfizer Company | Current | August 24, 2026 |
| Sodium Acetate, Injection, 200 mEq/100 mL (2 mEq/mL) (NDC 0409-3299-25) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
Every sodium acetate presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has sodium acetate been recalled?
The FDA's Enforcement Report lists 2 recalls naming sodium acetate since 2013: 1 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 4, 2022 | Class I | Fresenius Kabi USA, LLC | Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium … |
| February 26, 2013 | Class II | Hospira Inc. | Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for sodium acetate?
The FDA Adverse Event Reporting System holds 275 reports that list sodium acetate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 56 are coded as a death and 126 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other osmotic laxatives
- the pharmacologic class, with prices and generics
- Sodium acetate side effects
- the label's list beside FAERS reports
- Sodium acetate shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other