SODIUM ACETATE 164 mg/mL Injection, Solution, Concentrate — NDC 80830-2437-2 (Billing 80830-2437-02)
This is a package of SODIUM ACETATE 164 mg/mL Injection, Solution, Concentrate from Amneal Pharmaceuticals Private Limited, marketed since Aug 2025 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 80830-2437-2 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 80830 labeler · 2437 product · 2 package
- Package marketed since
- Aug 12, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 8083024372 4
- FDA record last changed
- Jul 24, 2026
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): 001205
- GCN: 02922
- GPI-14 (Medi-Span): 79050010002005
- HICL (First Databank): 000536
- AHFS class code: 40:12.00.00
- RxCUI (RxNorm): 237371
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 | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| 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 · refreshed Oct 5, 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 |
|---|---|---|---|---|
| 80830-2437-02 You're viewing this Main listing | 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE | 2025-08-12 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sodium Acetate 164 mg/mL 00409-3299-25 | Hospira, | 25 vials | — | AP | FDA listed | — |
| Sodium Acetate 164 mg/mL 00641-6262-01 | Hikma | 1 vial | — | AP | FDA listed | — |
| Sodium Acetate 164 mg/mL 00641-6263-10 | Hikma | 10 vials | — | AP | FDA listed | — |
| Sodium acetate anhydrous 164 mg/mL 70069-0047-25 | Somerset | 25 vials | — | AP | FDA listed | — |
| Sodium acetate anhydrous 164 mg/mL 70069-0048-20 | Somerset | 20 vials | — | AP | FDA listed | — |
| Sodium Acetate 164 mg/mL 71357-0007-10 | MILLA | 10 vials | — | AP | FDA listed | — |
| Sodium Acetate 200 meq/100mL 71357-0008-10 | MILLA | 10 vials | — | AP | FDA listed | — |
| Sodium Acetate 164 mg/mL 80830-2436-02 | Amneal | 25 vials | — | AP | FDA listed | — |
| Sodium Acetate 164 mg/mLthis 80830-2437-02 | Amneal | 10 vials | — | AP | FDA listed | — |
| Sodium Acetate 164 mg/mL 00641-6261-01 | Hikma | 1 vial | — | AP | FDA listed | — |
| Sodium Acetate 164 mg/mL 80830-2435-02 | Amneal | 25 bottles | — | 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
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 Amneal Pharmaceuticals Private Limited labeler code 80830
- CALCIUM GLUCONATE 20 mg/mL Injection, Solution NDC 80830-2362-2
- CALCIUM GLUCONATE 20 mg/mL Injection, Solution NDC 80830-2363-2
- PROPOFOL 10 mg/mL Injection, Emulsion NDC 80830-2364-8
- PROPOFOL 10 mg/mL Injection, Emulsion NDC 80830-2365-7
- Sodium Acetate 164 mg/mL Injection, Solution, Concentrate NDC 80830-2435-2
- SODIUM ACETATE 164 mg/mL Injection, Solution, Concentrate NDC 80830-2436-2
- Metronidazole 500 mg/100mL Injection, Solution NDC 80830-2465-9
- Iohexol 300 mg/mL Injection, Solution NDC 80830-2466-2
- Iohexol 300 mg/mL Injection, Solution NDC 80830-2467-2
- Iohexol 300 mg/mL Injection, Solution NDC 80830-2468-2
- Iohexol 350 mg/mL Injection, Solution NDC 80830-2471-2
- Iohexol 350 mg/mL Injection, Solution NDC 80830-2472-2
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, 2 mEq/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, 2 mEq/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, 2 mEq/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 Admixtures Service only. For hanger application, Pharmacy Bulk Package has been provided with integrated hanger within the label for your use.
Simply pull the tab and hang. The vials should be suspended as a unit in the laminar flow hood. A single entry through the vial closure should be made with a sterile dispensing set or transfer device.
Transfer individual doses to appropriate intravenous infusion solutions. Use of a syringe with needle is not recommended as it may cause leakage and multiple entries will increase the potential of microbial and particulate contamination. The above process should be carried out under a laminar flow hood using aseptic technique.
Discard any unused portion within 4 hours after initial closure entry.
⛔ Contraindications ▾
CONTRAINDICATIONS Sodium acetate injection, 2 mEq/mL is contraindicated in patients with hypernatremia or fluid retention.
⚠️ Warnings ▾
WARNINGS Sodium acetate injection, 2 mEq/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 ).
🆘 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/liter. 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, 100 mEq/50 mL and 200 mEq/100 mL (2 mEq/mL) is sterile, clear, colorless solution filled in 50 mL and 100 mL clear moulded vials with grey rubber stopper and dark red flip top seal and it is supplied in Pharmacy Bulk Packages as follows: Total Amounts NDC No. Fill Volume Na + Acetate Concentration 80830-2436-2 Carton containing 25 vials 50 mL 100 mEq 100 mEq 16.4% 80830-2437-2 Carton containing 10 vials 100 mL 200 mEq 200 mEq 16.4% Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd.
Ahmedabad 382110, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 05-2025-00
📋 Description ▾
DESCRIPTION Sodium acetate injection, USP (2 mEq/mL) is a sterile, clear, colorless, 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 164 mg of sodium acetate, USP (anhydrous) which provides 2 mEq each of sodium (Na + ) and acetate (CH 3 COO - ). The solution contains no bacteriostat, antimicrobial agent or added buffer. May contain acetic acid for pH adjustment; the pH is 6.5 (6.0 to 7.0).
The osmolar concentration is 4 mOsmol/mL (calc.); specific gravity 1.081. 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 CH 3 COONa, a hygroscopic powder freely 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.
Animal reproduction studies have not been conducted with sodium acetate injection. It is also not known whether sodium acetate injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium acetate injection 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 ▾
PRINCIPAL DISPLAY PANEL NDC 80830-2436-1 Sodium Acetate Injection USP, 100 mEq/50 mL (2 mEq/mL) 50 mL Vial Label Rx only Amneal Pharmaceuticals LLC NDC 80830-2436-2 Sodium Acetate Injection USP, 100 mEq/50 mL (2 mEq/mL) Carton Label (25 x 50 mL Pharmacy Bulk Package Vials) Rx only Amneal Pharmaceuticals LLC NDC 80830-2437-1 Sodium Acetate Injection USP, 200 mEq/100 mL (2 mEq/mL) 100 mL Vial Label Rx only Amneal Pharmaceuticals LLC NDC 80830-2437-2 Sodium Acetate Injection USP, 200 mEq/100 mL (2 mEq/mL) Carton Label (10 x 100 mL Pharmacy Bulk Package Vials) Rx only Amneal Pharmaceuticals LLC 1 2 3 2
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) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |