FDA-filed SPL labeling · retrieved through openFDA

Sodium Acetate

Sodium Acetate is an intravenous electrolyte additive used to prevent or correct low sodium levels (hyponatremia) in patients who cannot take sodium by mouth.

Brand names Sodium acetate anhydrousSodum Acetate
Rx Form 1 Route Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 27, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 12 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 →

At a glance
Linked label effectiveMar 26, 2026
Clinical labels in scope 12
AvailabilityRx
Earliest approval/marketing year 1971
FDA-listed product records 37
Boxed warningYes
How we combine label and product data →
Sodium Acetate at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Sodium Acetate Injection is a hospital-use electrolyte additive that corrects or prevents low sodium levels in patients on IV fluids. It must always be diluted before use and is dosed and monitored carefully by healthcare providers. Patients with heart failure, kidney disease, or liver problems require extra caution.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

This product is a Pharmacy Bulk Package — it is NOT for direct infusion into a patient. It must be prepared and diluted by pharmacy staff before being added to an IV fluid for administration. It is intended for use only in a pharmacy admixture setting and should never be infused directly as supplied.

Read the full warning on DailyMed →

📖 Sodium Acetate: Patient Information Guide

A plain-language walkthrough of Sodium Acetate — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Sodium Acetate Injection is an intravenous electrolyte used in hospital and clinical settings to manage sodium levels in patients who cannot take sodium by mouth. Supported uses include:

  • Preventing or correcting hyponatremia (low blood sodium) in patients with restricted or no oral intake — supported by Sodium Acetate Injection (2 mEq/mL) and Sodium Acetate Injection, USP (4 mEq per mL)
  • Serving as a sodium additive for preparing customized IV fluid formulas when standard electrolyte or nutrient solutions are not sufficient — supported by both formulations
⚙️How it works

Sodium is the body's primary electrolyte outside of cells, making up more than 90% of the positively charged particles in the fluid that surrounds your cells. It directly controls total body water and how that water is distributed. When sodium levels drop too low, the body's fluid balance is disrupted. The acetate component acts as a buffer — it accepts excess hydrogen ions (acid) and is converted by the liver into bicarbonate, which helps keep the blood's acid-base balance in the normal range. Notably, this conversion occurs even when the liver is significantly stressed.

💊How it's taken

Sodium Acetate Injection is given intravenously (by IV) only — and only after it has been properly diluted into a larger volume of IV fluid. It is never infused directly from the vial. The dose and rate of infusion are individualized by a healthcare provider and guided by regular monitoring of blood sodium levels.

  • Pharmacy Bulk Package vials are for pharmacy admixture preparation only, handled under sterile conditions
  • Prepared admixtures must be refrigerated and used within 24 hours; once a vial is opened, unused portions must be discarded within 4 hours
  • Only clear solutions with an intact seal should be administered
🤒Side effects — in detail

The main side effect to be aware of with Sodium Acetate Injection is sodium overload if too much is given too quickly.

  • Sodium overload: swelling, fluid retention, high blood pressure, or fluid in the lungs
  • Overhydration or dilution of other electrolytes in the blood
  • Low potassium (hypokalemia) if potassium-free solutions are given excessively

If you or your care team notice signs of swelling, breathing difficulty, or unusual weakness, escalate immediately — these can be signs of serious fluid or electrolyte imbalances.

⚠️Warnings & precautions
  • Must be diluted: This product is a Pharmacy Bulk Package — never for direct infusion. Always diluted before reaching the patient.
  • Sodium overload risk: Infuse slowly. Too much sodium too fast can cause fluid retention and overhydration, particularly dangerous in patients with congestive heart failure, severe kidney insufficiency, or edema.
  • Alkalosis risk: Acetate-containing solutions must be used very carefully in patients with metabolic or respiratory alkalosis (excess base in the blood) or impaired acetate utilization.
  • Liver disease caution: Use with great care in severe hepatic (liver) insufficiency, as the body may not properly convert acetate.
  • Aluminum toxicity: This product contains aluminum. With prolonged IV use in patients with impaired kidney function — especially premature newborns — aluminum can accumulate to toxic levels, potentially causing nervous system and bone damage. Patients receiving more than 4–5 mcg/kg/day of parenteral aluminum are at risk.
  • Kidney disease: Reduced kidney function can lead to sodium retention; monitor carefully.
🔀What it interacts with

The FDA label does not list specific drug-drug interactions for Sodium Acetate Injection, but important clinical considerations include:

  • Sodium-retaining conditions or medications: Using sodium-containing solutions alongside other factors that cause fluid or sodium retention increases the risk of overload
  • Potassium-free IV solutions: Excessive use without potassium replacement can lead to hypokalemia (low potassium), which can affect heart rhythm and muscle function

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Hypernatremia (too much sodium): Do not use — this medication adds sodium and would worsen the condition
  • Fluid retention: Contraindicated — extra sodium worsens water retention
  • Congestive heart failure: Use with great caution; sodium can worsen fluid overload
  • Severe kidney insufficiency: Use with great caution; impaired kidneys may not clear sodium or aluminum
  • Metabolic or respiratory alkalosis: Acetate worsens high-base states — use very carefully
  • Severe liver disease: The liver converts acetate to bicarbonate; impaired conversion may affect acid-base balance
  • Premature newborns: At highest risk for aluminum toxicity due to immature kidneys and high calcium/phosphate requirements
  • Any patient with impaired kidney function: At elevated risk for aluminum accumulation with prolonged use
🚑If you take too much

If too much Sodium Acetate is infused, the IV should be stopped immediately. Treatment focuses on lowering elevated blood sodium levels and restoring normal acid-base balance. A healthcare team will manage this in a clinical setting based on the patient's specific condition.

📡Pharmacodynamics — effects in the body

Sodium Acetate Injection raises sodium levels in the blood, helping to restore normal fluid distribution throughout the body. The acetate is converted by the liver into bicarbonate, which can help correct or prevent acidosis (excess acid in the blood). Because sodium controls how water moves between compartments in the body, restoring sodium levels also helps normalize hydration and blood volume.

📦How to store it

Store at 20° to 25ºC (68° to 77ºF).

📄 Written from Sodium Acetate’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

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 Injection actually used for?
It's used in a hospital or clinical setting to raise sodium levels in patients whose sodium has dropped too low — a condition called hyponatremia. This usually happens when someone can't eat or drink normally and is relying entirely on IV fluids. It can also be added to custom IV formulas when a standard solution isn't enough to meet your body's needs.
How is this medication given — do I swallow it or get a shot?
Neither, exactly. It's given through an IV line directly into a vein, but only after it's been carefully diluted by pharmacy staff into a larger bag of IV fluid. It's never injected directly from the vial — that would be unsafe. You'd receive it in a hospital or clinical setting, with your sodium levels monitored throughout.
What side effects should I watch for?
The main concern is getting too much sodium, which can cause swelling, fluid buildup, or in serious cases, fluid in the lungs. Your care team monitors your sodium levels closely to prevent this. If you notice sudden swelling, weight gain, or have trouble breathing during or after your infusion, let the nursing staff know right away.
Is there anyone who shouldn't receive this medication?
Yes. If you already have too much sodium in your blood (hypernatremia) or if your body is already retaining too much fluid, this medication should not be used. People with congestive heart failure, severe kidney disease, or certain acid-base imbalances need extra caution — your doctor will weigh the risks carefully before using it.
I've heard this medication contains aluminum — should I be worried?
This is a real concern for certain patients, particularly premature babies and anyone with significant kidney problems. When the kidneys aren't working well, aluminum from IV medications can build up over time and potentially affect the nervous system and bones. Your care team is aware of this and takes it into account, especially with long-term IV therapy.
Why does the label say 'not for direct infusion'?
The vial is what's called a Pharmacy Bulk Package — it's a concentrated solution meant to be used by pharmacists to prepare individual IV doses for multiple patients. It has to be diluted and transferred into appropriate IV fluids before it's safe to give. Infusing it directly and undiluted would deliver too much sodium too fast and could be harmful.
Is Sodium Acetate available over the counter?
Sodium Acetate is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Sodium Acetate first available?
Sodium Acetate has been available in the United States since at least 1971, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Sodium Acetate?
Sodium Acetate is supplied by 15 manufacturers listed in the FDA NDC Directory, including Hospira, Inc., Woodward Pharma Services LLC, Amneal Pharmaceuticals Private Limited.

💬 Answers drafted from Sodium Acetate’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Sodium Acetate 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.

Injection

Into a vein
Brands Sodium acetate anhydrous Sodum Acetate
How this form is used
What it may be used for
  • Sodium Acetate Injection is used as a source of sodium added to large-volume IV fluids to prevent or correct hyponatremia (low sodium) in patients with restricted or no oral intake
  • Sodium Acetate Injection is used as an additive for preparing specific IV fluid formulas when standard solutions cannot meet the patient's needs
Important instructions
  • Sodium Acetate Injection must always be diluted in a larger volume of IV fluid before administration — never infuse directly
  • Sodium acetate anhydrous (2 mEq/mL) and Sodium Acetate Injection, USP (4 mEq per mL) Pharmacy Bulk Packages are for pharmacy admixture use only, prepared under aseptic conditions in a laminar flow hood
  • Admixtures must be stored under refrigeration and used within 24 hours after compounding; discard any unused portion within 4 hours of initial vial entry
  • Dose and infusion rate are based on individual patient needs and are guided by monitoring of serum sodium levels
Available strengths 5 strengths
27 FDA-listed product records

📊 Sodium Acetate across the U.S. market

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.

1
Dose forms
15
Manufacturers
3
Brand names
37
FDA-listed product records
1971
First marketed

Also listed with the FDA, not a patient dose form: Crystal (5) · Powder (4) · Granule (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Hospira, Inc.22%
Woodward Pharma Services LLC14%
Amneal Pharmaceuticals Private Limited8%
Avantor Performance Materials, LLC8%
Hikma Pharmaceuticals USA Inc.8%
Fresenius Kabi USA, LLC5%
Other makers35%

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

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.

20,278
Medicaid prescriptions filled (Q1–Q4 2025)
$8.5M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Sodium Acetate prescribed? Of the 1,596 medications we measure, Sodium Acetate ranks #792 by Medicaid prescriptions — more than 50% of them.

Where Sodium Acetate ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

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.

The 2 mEq/mL injectable solution is the most-dispensed Sodium Acetate product — about 84% of these Medicaid prescriptions.

sodium acetate 2 MEQ/ML Injectable Solution Most dispensed

17,069 Medicaid prescriptions (Q1–Q4 2025) 84% of Sodium Acetate prescriptions shown $7.8M gross reimbursement (before rebates) ≈ $455 per prescription (gross)

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

1,709 Medicaid prescriptions (Q1–Q4 2025) 8% of Sodium Acetate prescriptions shown $357,181 gross reimbursement (before rebates) ≈ $209 per prescription (gross)

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

1,500 Medicaid prescriptions (Q1–Q4 2025) 7% of Sodium Acetate prescriptions shown $416,580 gross reimbursement (before rebates) ≈ $278 per prescription (gross)

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.)

Showing 37 of 37 products — FDA National Drug Code Directory. See every product, package size and price: browse all 37 Sodium Acetate NDCs →

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.

Ingredient (IN) Sodium Acetate RxCUI 56443 2 dose forms · 4 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 373892 In current FDA listings
    Clinical drug / strength (SCD) 2 MEQ/ML RxCUI 237371 4 MEQ/ML RxCUI 312965
  2. Dose form (SCDF) Injection RxCUI 1859489 In current FDA listings
    Clinical drug / strength (SCD) 20 ML sodium acetate 2 MEQ/ML RxCUI 1859490 50 ML sodium acetate 4 MEQ/ML RxCUI 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.

🏷️ Sold under these brand names

Sodium acetate anhydrous Sodum Acetate

🏭 Manufacturers & labelers

Hospira, Inc. 8 Woodward Pharma Services LLC 5 Amneal Pharmaceuticals Private Limited 3 Avantor Performance Materials, LLC 3 Hikma Pharmaceuticals USA Inc. 3 Fresenius Kabi USA, LLC 2 Macco Organiques Inc 2 Merck Life Science Technologies (Nantong) Co., Ltd. 2 Milla Pharmaceuticals Inc. 2 Somerset Therapeutics, LLC 2 American Regent, Inc. 1 Exela Pharma Sciences, LLC 1 Jost Chemical Co 1 Maeda Inc 1 Spectrum Laboratory Products, Inc. 1

RxNorm drug class

Sodium Acetate belongs to the Electrolyte solutions class.

Drug family (ATC) Electrolyte solutions

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.

🔬 Where this comes from

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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Mar 26, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Sodium Acetate.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Sodium Acetate after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
12
NDC products indexed
37
Distinct labelers/manufacturers represented
15
Linked representative label
Hospira, Inc.
Linked label effective
Mar 26, 2026
Composite sections available
13
Linked SPL Set ID
c3be2468-45e8-4ecc-a30b-e966743a563f
Linked SPL Document ID
b7a713f4-3c97-484b-b182-2824e1e944bb
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 12 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Hospira, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.