SODIUM ACETATE 4 meq/100mL Injection, Solution, Concentrate — NDC 63323-032-00 (Billing 63323-0032-00)
This is a package of SODIUM ACETATE 4 meq/100mL Injection, Solution, Concentrate from Fresenius Kabi USA, LLC, marketed since Oct 2017 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 63323-032-00 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 63323 labeler · 032 product · 00 package
- Package marketed since
- Oct 30, 2017
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 6332303200 5
- Medicaid fills, this package
- 1,440 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Past resolved recalls for this product (1)
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 001206
- GCN: 02923
- GPI-14 (Medi-Span): 79050010002010
- HICL (First Databank): 000536
- AHFS class code: 40:12.00.00
- RxCUI (RxNorm): 312965
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Electrolyte solutions class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It adds sodium to your IV fluids to prevent or correct low blood sodium when you can't eat or drink enough. It's also used to build custom IV fluid mixes when standard ones don't f...
- Only through a vein, after the pharmacy dilutes it in a larger bag of IV fluid. You'll never get it straight from the vial. Your care team sets the dose and speed based on you.
- Blood sodium levels guide how much you need. This helps avoid giving too little or too much.
- The main concern is too much sodium or fluid. Tell your nurse right away if you notice swelling or trouble breathing, since fluid overload can affect the lungs.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $1.61 | $3,225.20 / 2000 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 63323-0032-00 You're viewing this Main listing | 20 VIAL, PHARMACY BULK PACKAGE in 1 TRAY / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE | 2017-10-30 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sodium Acetate 4 meq/100mLthis 63323-0032-00 | Fresenius | 20 vials | — | AP | FDA listed | — |
| Sodium Acetate 400 meq/100mL 71357-0009-10 | MILLA | 10 vials | — | AP | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Sodium Acetate inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII Q40Q9N063P
Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
2 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Fresenius Kabi USA, LLC labeler code 63323
- Gentamicin 40 mg/mL Injection, Solution NDC 63323-010-02
- Chloramphenicol Sodium Succinate 1 g/10mL Injection, Powder, Lyophilized, For Solution NDC 63323-011-15
- Oxytocin 10 [USP'U]/mL Injection, Solution NDC 63323-012-01
- Thiamine 100 mg/mL Injection, Solution NDC 63323-013-02
- Mannitol 250 mg/mL Injection, Solution NDC 63323-024-25
- Chorionic Gonadotropin Kit NDC 63323-030-11
- Cyanocobalamin 1000 ug/mL Injection, Solution NDC 63323-044-01
- Heparin Sodium 5000 [USP'U]/mL Injection, Solution NDC 63323-047-10
- Magnesium Sulfate 500 mg/mL Injection, Solution NDC 63323-064-02
- Sodium Bicarbonate 42 mg/mL Injection, Solution NDC 63323-083-05
- Sodium Chloride 234 mg/mL Injection, Solution NDC 63323-088-61
- Sodium Bicarbonate 84 mg/mL Injection, Solution NDC 63323-089-50
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE: Sodium Acetate Injection, USP (4 mEq per mL) 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.
⏱️ Dosage and Administration ▾
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
⛔ Contraindications ▾
CONTRAINDICATIONS: Sodium Acetate Injection, USP (4 mEq per mL) is contraindicated in patients with hypernatremia or fluid retention.
⚠️ Warnings ▾
WARNINGS: Sodium Acetate Injection, USP (4 mEq per mL) must be diluted before use. To avoid sodium overload and water retention, infuse sodium-containing solutions slowly. Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention.
In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention. Solutions containing acetate ions should be used with great care in patients with metabolic or respiratory alkalosis. Acetate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency.
The intravenous administration of this solution (after appropriate dilution) can cause fluid and/or solute overloading resulting in dilution of other serum electrolyte concentrations, overhydration, congested states or pulmonary edema. Excessive administration of potassium free solutions may result in significant hypokalemia. WARNING: This product contains aluminum that may be toxic.
Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity.
Tissue loading may occur at even lower rates of administration.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS: Sodium overload can occur with intravenous infusion of excessive amounts of sodium-containing solutions (see WARNINGS and PRECAUTIONS ).
🤰 Pregnancy ▾
Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with Sodium Acetate Injection, USP. It is also not known whether Sodium Acetate Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Acetate Injection, USP should be given to a pregnant woman only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness have been established in the age groups infant to adolescent.
🧓 Geriatric Use ▾
Geriatric Use An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Sodium ions are known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
🆘 Overdosage ▾
OVERDOSAGE: In the event of overdosage, discontinue infusion containing sodium acetate immediately and institute corrective therapy as indicated to reduce elevated serum sodium levels, and restore acid-base balance if necessary (see WARNINGS , PRECAUTIONS and ADVERSE REACTIONS ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY: Sodium is the principal cation of extracellular fluid. It comprises more than 90% of total cations at its normal plasma concentration of approximately 140 mEq/L. The sodium ion exerts a primary role in controlling total body water and its distribution.
Acetate (CH 3 COO - ) is a hydrogen ion acceptor. It also serves as an alternate source of bicarbonate (HCO 3 - ) by metabolic conversion in the liver. This conversion has been shown to proceed readily, even in the presence of severe liver disease.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Sodium Acetate Injection, USP is packaged in a pharmacy bulk package vial, 20 vials per tray, and is available as follows: Product No. NDC No. Sodium Acetate Content (%) Na + (sodium) mEq/mL CH 3 COO - (acetate) mEq/mL mOsmol/mL Fill Vol. (mL) 322100 63323-032-00 32.8 4 4 8 100 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451406 Issued: December 2017 Figure
📋 Description ▾
DESCRIPTION: Sodium Acetate Injection, USP (4 mEq per mL) is a sterile, nonpyrogenic, concentrated solution of sodium acetate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted.
Each mL contains: 328 mg sodium acetate (anhydrous) which provides 4 mEq each of sodium (Na + ) and acetate (CH 3 COO - ). The solution contains no bacteriostat, antimicrobial agent or added buffer. The pH may have been adjusted with glacial acetic acid to 6.5 (6.0 to 7.0).
The osmolar concentration is 8 mOsmol/mL (calc); specific gravity 1.1511. The solution is intended as an alternative to sodium chloride to provide sodium ion (Na + ) for addition to large volume infusion fluids for intravenous use. Sodium acetate, USP anhydrous is chemically designated as CH 3 COONa, a hygroscopic powder very soluble in water.
A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion.
⚠️ Precautions ▾
PRECAUTIONS: Do not administer unless solution is clear and seal is intact. Discard unused portion. Sodium replacement therapy should be guided primarily by the serum sodium level.
Caution should be exercised in administering sodium-containing solutions to patients with severe renal function impairment, cirrhosis, cardiac failure or other edematous or sodium-retaining states, as well as in patients with oliguria or anuria. Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin. Solutions containing acetate ions should be used with caution as excess administration may result in metabolic alkalosis.
Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with Sodium Acetate Injection, USP. It is also not known whether Sodium Acetate Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Acetate Injection, USP should be given to a pregnant woman only if clearly needed.
Pediatric Use Safety and effectiveness have been established in the age groups infant to adolescent. Geriatric Use An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Sodium ions are known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Acetate 400 mEq per 100 mL Vial Label NDC 63323-032-04 Sodium Acetate Injection, USP 400 mEq per 100 mL (4 mEq per mL) PHARMACY BULK PACKAGE– NOT FOR DIRECT INFUSION CAUTION: MUST BE DILUTED For Intravenous Use Only 100 mL Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Acetate 400 mEq per 100 mL Vial Label
PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Acetate 400 mEq per 100 mL Tray Label NDC 63323-032-00 Sodium Acetate Injection, USP 400 mEq per 100 mL (4 mEq per mL) PHARMACY BULK PACKAGE– NOT FOR DIRECT INFUSION For Intravenous Use Only 20 (1 x 20) 100 mL Vials Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Acetate 400 mEq per 100 mL Tray Label
Medicaid utilization & spend
Medicare Part D spend CMS · PART D · 2026 (Q1)
About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |