Quick answers
- What is Potassium acetate used for?
- The FDA-approved label (Potassium Acetate, Hospira, Inc., April 27, 2026) says: “Potassium Acetate Injection, USP, 40 mEq is indicated as a source of potassium, for the addition to large volume intravenous fluids, to prevent or correct hypokalemia 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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Potassium acetate have a boxed warning?
- No. None of the 7 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Potassium acetate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Potassium acetate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Potassium acetate?
- 3 companies list prescription products of Potassium acetate in the FDA NDC Directory, including Hospira, Inc., Fresenius Kabi USA, LLC and Exela Pharma Sciences, LLC.
What Potassium acetate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Potassium Acetate Injection, USP, 40 mEq is indicated as a source of potassium, for the addition to large volume intravenous fluids, to prevent or correct hypokalemia 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 label: Potassium Acetate, Hospira, Inc., effective April 27, 2026. Read the full label on DailyMed →
The FDA has 7 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 7 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution, concentrate · Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 5 in the FDA NDC Directory |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Hospira, Inc.4 products
- Fresenius Kabi USA, LLC2 products
- Exela Pharma Sciences, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA018896 POTASSIUM ACETATE | Hospira | July 20, 1984 | 12, latest June 12, 2014 2014: Manufacturing (CMC) · 2002: Manufacturing (CMC) · 2001: Manufacturing (CMC) |
Generic approvals (2)
- ANDA206203Exela Pharma · December 29, 2015
- ANDA217515Fresenius Kabi USA · November 27, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 237381, 1871155 |
|---|---|
| SPL set ID of the quoted label | c7eabefd-2781-439b-b8f4-cb3ea25a4720 |
| FDA labels (SPL) | 7 |
| FDA applications | NDA018896, 2 ANDA |
| Active ingredients (FDA) | POTASSIUM ACETATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Potassium Acetate, Hospira, Inc., effective April 27, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →