Sodium Chloride 234 mg/mL Injection, Solution
Other active recalls for Sodium Chloride (different manufacturers) — 6 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Sodium class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- Yes, exactly. Saline is just sodium chloride dissolved in water — it's essentially a sterile salt-water solution. Depending on the concentration and form, it can be used as an IV f...
- I've heard of saline solution — is that the same thing as sodium chloride?
- In some situations — like after surgery, during serious illness, or when someone can't take anything by mouth — the body needs fluids and electrolytes delivered directly into the b...
- Why would someone need sodium chloride through an IV? Can't you just drink water?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Sodium Chloride — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 | $0.0953 | $95.30 / 1000 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J7799 | No ASP payment limit on file for J7799 this quarter. | |
Where does this data come from?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sodium Chloride 234 mg/mL 00409-1141-02 | Hospira, | 25 vials | — | AP | FDA listed | — |
| Sodium Chloride 234 mg/mLthis 63323-0088-61 | Fresenius | 10 vials | — | — | FDA listed | — |
| Sodium Chloride 4 meq/mL 63323-0095-61 | Fresenius | 20 vials | — | — | FDA listed | — |
| Sodium Chloride 4 meq/mL 63323-0099-63 | Fresenius | 10 vials | — | AP | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63323-0088-61 You're viewing this | 10 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-088-61) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE | 2001-01-12 | Active |
| 63323-0088-63 | 10 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-088-63) / 200 mL in 1 VIAL, PHARMACY BULK PACKAGE | 2001-01-12 | Active |
This pack accounts for about 23% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in NDC 63323-0088-61?
What NDC number is used to bill for this package of Sodium Chloride 234 mg/mL Injection, Solution?
🧭 About this NDC listing & data coverage
Listed without an FDA application
This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.
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) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
Is this NDC FDA-approved?
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Sodium Chloride Injection, USP is indicated for parenteral restoration of sodium ion in patients with restricted oral intake. Sodium replacement is specifically indicated in patients with hyponatremia or low salt syndrome. Sodium chloride injection may also be added to compatible carbohydrate solutions such as dextrose in water to provide electrolytes.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Sodium chloride injection is administered intravenously only after addition to a larger volume of fluid. The dose, dilution and rate of injection are dependent upon the individual needs of each patient. All or part of the contents of one or more additive containers may be added to an intravenous solution container. Concentrations of up to 5% sodium chloride have been administered.
⛔ Contraindications ▾
CONTRAINDICATIONS Sodium chloride injection is contraindicated in patients with hypernatremia or fluid retention.
⚠️ Warnings ▾
WARNINGS 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. 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 may result in sodium retention. 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.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS None known.
🆘 Overdosage ▾
OVERDOSAGE In the event of overhydration or solute overload, reevaluate the patient and institute appropriate corrective measures. (See WARNINGS and PRECAUTIONS .)
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Sodium chloride in water dissociates to provide sodium (Na + ) and chloride (CI — ) ions. These ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance. Sodium is the principal cation of extracellular fluid.
It comprises more than 90% of the total cations at its normal plasma concentration of approximately 142 mEq/L. While the sodium ion can diffuse across cell membranes, intracellular sodium is maintained at a much lower concentration than extracellular sodium through the expenditure of energy by the cell (so-called ‘‘sodium cation pump’’). Loss of intracellular potassium ion is usually accompanied by an increase in intracellular sodium ion.
When serum sodium concentration is low, the secretion of antidiuretic hormone (ADH) by the pituitary is inhibited, thereby preventing water reabsorption by the distal renal tubules. On the other hand, adrenal secretion of aldosterone increases renal tubular reabsorption of sodium in an effort to reestablish normal serum sodium concentration. Chloride (CI — ) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells.
The distribution and excretion of sodium (Na + ) and chloride (CI — ) are largely under the control of the kidney which maintains a balance between intake and output.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Sodium Chloride Injection, USP is available in flip-top glass vials. Product No. NDC No. % NaCI Na + mEq/mL CI – mEq/mL mOsmol/ mL Fill Volume mL 88B1 63323-088-61 23.4 4 4 8 100 88B2 63323-088-63 23.4 4 4 8 200 Packaged in 20 and 10 vials per tray, respectively. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not permit to freeze.
📋 Description ▾
DESCRIPTION Sodium Chloride Injection, USP is a sterile, nonpyrogenic, concentrated solution for intravenous administration ONLY AFTER DILUTION to replenish electrolytes. The preparation contains 4 mEq/mL (23.4%) sodium chloride, in Water for Injection. The solution contains no bacteriostat, antimicrobial agent or added buffer; pH of the solution ranges from 4.5 to 7.0.
Each mL contains: Sodium chloride 234 mg; Water for Injection q.s. pH may have been adjusted with hydrochloric acid. The osmolar concentration of the 4 mEq/mL solution is 8 mOsmol/mL (calculated). Sodium chloride is chemically designated NaCI, a white crystalline compound freely soluble in water.
A pharmacy bulk package is a sterile dosage form containing many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for IV infusion.