Sodium Acetate
Sodium acetate is an intravenous (IV) additive that supplies sodium to prevent or correct low blood sodium (hyponatremia) in people who can't take enough by mouth.
🧬 Where this information comes from
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 10 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Sodium acetate is a standard hospital IV additive, on the market since about 1986 and available generically, that pharmacies mix into larger fluid bags to prevent or correct low blood sodium (hyponatremia) when someone cannot take enough by mouth; the liver turns its acetate into bicarbonate. Given properly, most people notice nothing; too much causes swelling or shortness of breath from fluid in the lungs. Its boxed warning, Pharmacy Bulk Package, not for direct infusion, means pharmacy staff dilute it first; it never runs straight into a vein. Blood sodium checks guide dosing, and heart failure, kidney disease, severe liver problems or fluid retention call for extra caution.
Clinical pearls
- Clinicians often choose it over sodium chloride when they want to give sodium without adding more chloride.
- Because acetate becomes bicarbonate, it is used with great care when the blood is already too alkaline (alkalosis).
- It carries no potassium, so heavy use of potassium-free fluids can lower potassium, which is why potassium gets checked alongside sodium.
- It contains aluminum, which can build up with long-term IV use, especially with weak kidneys or in premature newborns.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
This is a Pharmacy Bulk Package and is not for direct infusion. It is a large container meant only for pharmacy staff to prepare IV mixtures. It must never be given to a patient straight from the container.
Patient Information Guide A plain-language walkthrough of Sodium Acetate, written from its FDA label.
What Sodium Acetate Is Used For
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Sodium acetate is an IV sodium source with these supported uses:
- Sodium acetate injection (2 mEq/mL) is added to large-volume IV fluids to prevent or correct hyponatremia in patients with restricted or no oral intake.
- Sodium Acetate Injection, USP (4 mEq per mL) has the same use.
- Both are also additives for preparing specific IV fluid formulas when standard electrolyte or nutrient solutions can't meet a patient's needs.
How Sodium Acetate Works
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Sodium is the main cation (positively charged particle) in the fluid outside cells. It plays a primary role in controlling total body water and how it is distributed.
Acetate accepts hydrogen ions. The liver also converts it to bicarbonate, which has been shown to work even in severe liver disease.
Sodium Acetate Dosage
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Sodium acetate is given only into a vein, by trained staff, after dilution in a larger volume of IV fluid. Dose and rate depend on the individual patient, and serum sodium is monitored as a guide.
- The pharmacy bulk package is for pharmacy admixture use only, under a laminar flow hood with aseptic technique.
- Unused portions are discarded within 4 hours after the container is first entered.
- Mixed solutions are refrigerated and used within 24 hours.
- The solution is checked for particles and discoloration before use.
Dosing details from the FDA-approved label
From the Sodium Acetate prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Sodium acetate injection (2 mEq/mL and 4 mEq per mL), all patients (no condition-specific regimen given)
- Administered intravenously only after dilution in a larger volume of fluid
- The dose and rate of administration are dependent upon the individual needs of the patient
- Using aseptic technique, transfer the desired amount to other intravenous fluids to provide the appropriate number of milliequivalents (mEq) of sodium acetate
- Serum sodium should be monitored as a guide to dosage. Admixtures must be stored under refrigeration and used within 24 hours after compounding.
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION: Sodium Acetate Injection, USP (4 mEq per mL) is administered intravenously only after dilution in a larger volume of fluid. The dose and rate of administration are dependent upon the individual needs of the patient. Serum sodium should be monitored as a guide to dosage. Using aseptic technique, transfer the desired amount to other intravenous fluids to provide the appropriate number of milliequivalents (mEq) of sodium acetate. Sodium Acetate Injection, USP (4 mEq per mL) in the Pharmacy Bulk Package is designed for use with manual, gravity flow operations and automated compounding devices for preparing intravenous nutritional admixtures. Admixtures must be stored under refrigeration and used within 24 hours after compounding. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration (see PRECAUTIONS ). Directions for Dispensing from Pharmacy Bulk Package The Pharmacy Bulk Package is for use in the Pharmacy Admixture Service only in a laminar flow hood. It should be inserted into the ring sling (plastic hanging device) provided and suspended as a unit in the laminar flow hood. The container closure should be penetrated only one time utilizing a suitable sterile dispensing set which allows measured distribution of the contents. Swab vial stopper with an antiseptic solution. Insert the dispensing set into the vial using aseptic technique (see graphic illustration below ). Once the sterile dispensing set has been inserted into the container, withdrawal of the contents should be accomplished without delay. However, if this is not possible, a maximum time of 4 hours from the initial entry may be allowed to complete fluid aliquoting/transferring operations. Discard the container no later than 4 hours after initial closure puncture. Do not administer unless solution is clear and seal is intact. Figure
Read the full Dosage and Administration section on DailyMed →
Sodium Acetate Side Effects
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The label names one main adverse reaction:
Common side effects
- Sodium overload if too much sodium-containing fluid is given
- Fluid overload or overhydration
- Water retention
- Diluted levels of other blood salts (electrolytes)
- Low potassium (hypokalemia) with excess potassium-free solutions
When to get medical help
- Signs of fluid overload, such as swelling or shortness of breath (pulmonary edema, fluid in the lungs), need urgent attention
- Signs of too much sodium or water retention should be reported to your care team right away
- Tell your care team if you have worsening kidney problems while receiving sodium-containing fluids
- Aluminum can build up with prolonged IV use, especially in people with poor kidney function and in premature newborns
Sodium Acetate Warnings and Precautions
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- Dilute first and infuse slowly to avoid sodium overload and water retention.
- Use with great care, if at all, in heart failure, severe kidney impairment and edema with sodium retention.
- Use great care in alkalosis and severe liver insufficiency.
- Fluid overload can dilute other electrolytes and cause pulmonary edema.
- Potassium-free solutions in excess can cause low potassium.
- Aluminum content may be toxic with prolonged use, especially with poor kidney function and in premature newborns.
Before Taking Sodium Acetate
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- Not for people with hypernatremia (high blood sodium) or fluid retention (4 mEq per mL product).
- Extra caution with heart failure, kidney problems, or edema with sodium retention.
- Extra caution with metabolic or respiratory alkalosis.
- Extra caution with severe liver insufficiency.
- Premature newborns and people with poor kidney function are at higher risk from aluminum.
Sodium Acetate Overdose
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Too much can raise blood sodium and upset acid-base balance. The label says to stop the sodium acetate infusion immediately. Treatment is then given to lower sodium and restore acid-base balance if needed.
What Sodium Acetate Does in the Body
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Sodium makes up more than 90% of the positively charged particles in blood plasma, at a normal level of about 140 mEq/liter. It controls total body water and its distribution. Acetate accepts hydrogen ions and serves as an alternate source of bicarbonate.
How Your Body Processes Sodium Acetate
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Acetate is converted to bicarbonate by the liver. The label says this conversion proceeds readily, even in the presence of severe liver disease.
How to Store Sodium Acetate
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Store at 20° to 25ºC (68° to 77ºF).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Sodium Acetate: Pharmacist Answers to Common Questions
Quick, plain-English answers to the questions patients ask most about Sodium Acetate — the kind of thing our pharmacy team would talk through with you at the counter.
What is sodium acetate used for?
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How will I receive it?
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Why do they check my blood sodium?
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What side effects should I watch for?
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Who should be extra careful with it?
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Does the aluminum in it matter?
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Is Sodium Acetate available over the counter?
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When was Sodium Acetate first available?
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Who makes Sodium Acetate?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More About Sodium Acetate on HelloPharmacist
Sodium Acetate Forms and Strengths (How It Comes)
Sodium Acetate is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Sodium Acetate inactive ingredients by manufacturer.
Injection
How this form is used
- Sodium acetate injection (2 mEq/mL) is a sodium source added to large-volume IV fluids to prevent or correct hyponatremia.
- Sodium Acetate Injection, USP (4 mEq per mL) is a sodium source added to large-volume IV fluids to prevent or correct hyponatremia.
- Sodium acetate injection is also an additive for specific IV fluid formulas when standard solutions can't meet patient needs.
- Sodium acetate injection (2 mEq/mL) is given intravenously only after dilution in a larger volume of fluid.
- Sodium Acetate Injection, USP (4 mEq per mL) is given intravenously only after dilution, with serum sodium monitored.
- Sodium acetate pharmacy bulk packages are for pharmacy admixture use only, using aseptic technique.
- Sodium acetate admixtures must be refrigerated and used within 24 hours after compounding.
Sodium Acetate on the U.S. Market: Products, Makers and Brands
How Sodium Acetate appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
6 companies list 13 Sodium Acetate product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 1971. Brand names on the directory include Sodium acetate anhydrous; the rest are generics.
Also listed with the FDA, not a patient dose form: Crystal (5) · Powder (4) · Granule (1) — bulk drug substance and unfinished product sold to compounders and other manufacturers to finish, and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How Widely Sodium Acetate Is Used (Medicaid Data)
A general measure of how commonly Sodium Acetate is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Sodium Acetate is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Sodium Acetate prescribed? Of the 1,603 medications we measure, Sodium Acetate ranks #793 by Medicaid prescriptions — more than 51% of them.
Utilization by Sodium Acetate product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
sodium acetate 2 MEQ/ML Injectable Solution Most dispensed
Summed across the 6 of 27 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 237371
20 ML sodium acetate 2 MEQ/ML Injection
Summed across the 2 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1859490
sodium acetate 4 MEQ/ML Injectable Solution
Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312965
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Sodium Acetate, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 9 of 41 listed Sodium Acetate NDCs with Medicaid activity.
Compare Sodium Acetate Products
A representative set of FDA-listed product records for Sodium Acetate — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 164 mg/mL | Intravenous | Amneal Pharmaceuticals Private Limited × 3 listings | ANDA | View NDC → |
| 4 mEq/100 mL | Intravenous | Fresenius Kabi USA, LLC | ANDA | View NDC → |
| 164 mg/mL | Intravenous | Hikma Pharmaceuticals USA Inc. × 3 listings | ANDA | View NDC → |
| 164 mg/mL | Intravenous | Hospira, Inc. | NDA | View NDC → |
| 3.28 g/20 mL | Intravenous | Hospira, Inc. | NDA | View NDC → |
| 164 mg/mL | Intravenous | Milla Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
| 164 mg/mL | Intravenous | Somerset Therapeutics, LLC × 2 listings | ANDA | View NDC → |
Showing 13 of 13 products — FDA National Drug Code Directory. See every product, package size and price: browse all 13 Sodium Acetate NDCs →
Sodium Acetate Side Effects Reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Sodium Acetate — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Sodium Acetate in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Sodium Acetate FDA Approval History
How Sodium Acetate went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Sodium Acetate Recall History
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list one Sodium Acetate recall since July 2021. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032-00), each vial: 100 mL fill in a 100 mL vial (NDC 63323-032-04), Rx Only, Fres… Lots: Lot #: 6124193, 6124196, 6124226, Exp 05/2022; 6124532, Exp 06/2022; 6125333, Exp 12/2022; 6125678, Exp 01/2023; 6126846, Exp 08/2023 FDA record D-0750-2022 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Oct 8, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 56443 2 dose forms · 4 strengths
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Dose form (SCDF) Injectable Solution RxCUI 373892In current FDA listings -
Dose form (SCDF) Injection RxCUI 1859489In current FDA listingsClinical drug / strength (SCD) 20 ML sodium acetate 2 MEQ/MLRxCUI 185949050 ML sodium acetate 4 MEQ/MLRxCUI 1859502
Look up RxCUI 56443 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Sodium Acetate Supply and Shortage Status
Whether Sodium Acetate is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Sodium Acetate Brand Names
Sodium Acetate is sold under one brand name in the FDA directory — Sodium acetate anhydrous. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who Makes Sodium Acetate: Manufacturers and Labelers
6 companies list Sodium Acetate products with the FDA. By number of product records, the largest are Amneal Pharmaceuticals Private Limited, Hikma Pharmaceuticals USA Inc., Hospira, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Sodium Acetate Drug Class (RxNorm)
Sodium Acetate belongs to the Electrolyte solutions class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for This Sodium Acetate Page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Hospira, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →