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SODIUM ACETATE 164 mg/mL Injection, Solution, Concentrate — NDC 80830-2436-02 package photo

SODIUM ACETATE 164 mg/mL Injection, Solution, Concentrate

by Amneal Pharmaceuticals Private Limited · 25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (80830-2436-2) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (80830-2436-1)
NDC 80830-2436-02
🏷️ FDA NDC (as labeled) 80830-2436-2 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 80830-2436-2
Product NDC 80830-2436
11-digit billing NDC 80830243602
NCPDP billing unit ML — per mL (volume)
RxCUI 237371
UNII NVG71ZZ7P0
Application # ANDA218469
SPL Set ID 338105c0-c645-4b84-a125-4e1ead92b840
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-08-12
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION, CONCENTRATE
Substance SODIUM ACETATE ANHYDROUS
GPI-14 79050010002005
GCN Seq No 001205
GCN 02922
HICL code 000536
Ingredient (HICL) Sodium Acetate
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C0
Therapeutic class — intermediate (HIC2) Affect Fluid/Acid-Base Balance/Metabolic Systems
HIC3 code C0K
Therapeutic class — specific (HIC3) Bicarbonate Producing/Containing Agents
AHFS code 40:12.00.00
AHFS class Replacement Preparations
FDB label name SODIUM ACETATE 100 MEQ/50 ML
FDB brand name Sodium Acetate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 80830-2436-2 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 80830-2436-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Electrolyte solutions class.

Drug family (ATC) Electrolyte solutions
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAmneal Pharmaceuticals Private Limited
Application holderAMNEAL EU LTD
FDA applicationANDA218469 (ANDA)
Labeler code80830
First marketedAug 2025
Product typeHuman Prescription Drug
Portfolio27 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name SODIUM ACETATE 100 MEQ/50 ML Ingredient Sodium Acetate
📗 Our plain-language guide HelloPharmacist
  • 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...
  • What is Sodium Acetate Injection actually used for?
  • 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 injecte...
  • How is this medication given — do I swallow it or get a shot?
📖 Read our full Sodium Acetate guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer mLPer 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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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/mLthis 80830-2436-02 Amneal 25 vials — AP FDA listed —
Sodium Acetate 164 mg/mL 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 —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2025
On the market since
Aug 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Sodium Acetate — the program that covers self-administered drugs. 4 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Sodium Acetate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$8.1K
Claims incl. refills
139
Beneficiaries
32
Spend / beneficiary
$253.98
Spend / claim
$58.47
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
80830-2436-02 You're viewing this 25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (80830-2436-2) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (80830-2436-1) 2025-08-12 Active

🧭 About this NDC listing & data coverage

Finished prescription product
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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 80830-2436-2, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 80830-2436-02, written without dashes as 80830243602. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 80830-2436-02, the first segment (80830) is the labeler code FDA assigned to Amneal Pharmaceuticals Private Limited; the middle segment (2436) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Amneal Pharmaceuticals Private Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Amneal Pharmaceuticals Private Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 63 words ▾

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 ~1 min read ▾

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 15 words ▾

CONTRAINDICATIONS Sodium acetate injection, 2 mEq/mL is contraindicated in patients with hypernatremia or fluid retention.

⚠️ Warnings ~1 min read ▾

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 20 words ▾

ADVERSE REACTIONS Sodium overload can occur with intravenous infusion of excessive amounts of sodium-containing solutions (see WARNINGS and PRECAUTIONS ).

🆘 Overdosage 38 words ▾

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 88 words ▾

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 133 words ▾

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 188 words ▾

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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 80830-2435-02 · Amneal 80830-2437-02 · Amneal →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.