Sodium Chloride 5 g/100mL Injection, Solution — NDC 0338-0056-03 (Billing 00338-0056-03)
This is a package of Sodium Chloride 5 g/100mL Injection, Solution from Baxter Healthcare Corporation, marketed since Nov 1983 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 0338-0056-03 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0338 labeler · 0056 product · 03 package
- Package marketed since
- Nov 1, 1983
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 0338005603 3
- FDA record last changed
- Jul 24, 2026
Other active recalls for Sodium Chloride (different manufacturers) — 6 · tap to view
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): 001213
- GCN: 02965
- GPI-14 (Medi-Span): 79750010002040
- HICL (First Databank): 008257
- AHFS class code: 40:12.00.00
- RxCUI (RxNorm): 730781
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 Sodium class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It depends on the product. IV forms replace fluid and salt, while injection diluents dissolve other drugs. Other forms are used for rinsing, nasal congestion and nasal care, or to...
- Follow the directions on your product. Many are used as often as needed by adults and children 4 and over. Do not share the bottle, because that can spread infection.
- Some people get fever, irritation or infection at the IV site, or too much fluid in the body. Tell your nurse right away if the IV site hurts or looks red.
- What side effects should I expect with IV sodium chloride?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Sodium Chloride — tap one for details:
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 · Q2 2026 | $0.0178 | $213.60 / 12000 ml |
| Medicare Part B allowsASP · J7799 | No ASP payment limit on file for J7799 this quarter. | |
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
Billing & reimbursement
Where does this data come from?
- CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
- DMEPDAC NDC-HCPCS crosswalk
- openFDA NSDE billing units · refreshed Sep 7, 2026
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00338-0056-03 You're viewing this Main listing | 24 BAG in 1 CARTON / 500 mL in 1 BAG | 1983-11-01 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sodium Chloride 5 g/100mL 00264-7806-10 | B. | 500 ml | — | AP | FDA listed | — |
| Sodium Chloride 5 g/100mLthis 00338-0056-03 | Baxter | 500 ml | — | 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
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?
- 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.
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.- 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 Baxter Healthcare Corporation labeler code 00338
- Sodium Chloride 900 mg/100mL Irrigant NDC 0338-0047-27
- SODIUM CHLORIDE 900 mg/100mL Irrigant NDC 0338-0048-02
- Sodium Chloride 9 g/1000mL Injection, Solution NDC 0338-0049-01
- Sodium Chloride 900 mg/100mL Solution NDC 0338-0050-47
- Sodium Chloride 9 g/1000mL Irrigant NDC 0338-0051-44
- Sodium Chloride 3 g/100mL Injection, Solution NDC 0338-0054-03
- DEXTROSE 5 g/100mL Injection, Solution NDC 0338-0062-30
- DOXIL doxorubicin hydrochloride 2 mg/mL Injection, Suspension, Liposomal NDC 0338-0063-01
- DEXTROSE 5 g/100mL Injection, Solution NDC 0338-0066-20
- DOXIL doxorubicin hydrochloride 2 mg/mL Injection, Suspension, Liposomal NDC 0338-0067-01
- KETOROLAC TROMETHAMINE 15 mg/mL Injection, Solution NDC 0338-0069-10
- DEXTROSE 5 g/100mL Injection, Solution NDC 0338-0070-10
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 3% and 5% Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION As directed by a physician. Dosage, rate, and duration of administration are to be individualized and depend upon the indication for use, the patient’s age, weight, clinical condition, concomitant treatment, and on the patient’s clinical and laboratory response to treatment. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Use of a final filter is recommended during administration of all parenteral solutions, where possible. Do not administer unless solution is clear and seal is intact. All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile and nonpyrogenic equipment.
Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used.
Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced.
Do not store solutions containing additives. After opening the container, the contents should be used immediately and should not be stored for a subsequent infusion. Do not reconnect any partially used containers.
Discard any unused portion.
⛔ Contraindications ▾
CONTRAINDICATIONS None known.
⚠️ Warnings ▾
WARNINGS Hypersensitivity/infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus may occur with 3% and 5% Sodium Chloride Injection, USP. Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing. Appropriate therapeutic countermeasures must be instituted as clinically indicated.
Depending on the volume and rate of infusion, the intravenous administration of 3% and 5% Sodium Chloride Injection, USP can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration/hypervolemia, congested states, pulmonary edema, or acid-base imbalance. The risk of dilutive states is inversely proportional to the electrolyte concentration of the injection. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injection.
Monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation. Administer 3% and 5% Sodium Chloride Injection, USP with particular caution to patients with or at risk for hypernatremia, hyperchloremia, hypervolemia or with conditions that may cause sodium retention, fluid overload and edema; such as patients with primary hyperaldosteronism, or secondary hyperaldosteronism (for example, associated with hypertension, congestive heart failure, liver disease (including cirrhosis), renal disease (including renal artery stenosis, nephrosclerosis) or pre-eclampsia).
Certain medications may increase risk of sodium and fluid retention, see DRUG INTERACTIONS. Administer 3% and 5% Sodium Chloride Injection, USP with particular caution to patients with severe renal impairment. In such patients administration of Sodium Chloride Injection, USP may result in sodium retention.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Post-Marketing Adverse Reactions The following adverse reactions have not been reported with 3% and 5% Sodium Chloride Injection, USP but may occur: • hyperchloremia • hyperchloremic metabolic acidosis, • hypersensitivity/infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus, • Infusion site reactions, such as thrombosis, phlebitis, irritation, infusion site erythema, injection site streaking, burning sensation, infusion site urticaria. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.
🔄 Drug Interactions ▾
Drug Interactions Caution must be exercised in the administration of 3% and 5% Sodium Chloride Injection, USP to patients treated with drugs that may increase the risk of sodium and fluid retention, such as corticosteroids. Caution is advised in patients treated with lithium. Renal sodium and lithium clearance may be increased during the administration of 3% and 5% Sodium Chloride Injection, USP.
Administration of 3% and 5% Sodium Chloride Injection, USP may, therefore, result in decreased lithium levels.
🤰 Pregnancy ▾
Pregnancy There are no adequate and well controlled studies with 3% and 5% Sodium Chloride Injection, USP in pregnant women and animal reproduction studies have not been conducted with this drug. Therefore, it is not known whether 3% and 5% Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman. 3% and 5% Sodium Chloride Injection, USP should be given during pregnancy only if the potential benefit justifies the potential risks to the fetus.
🧒 Pediatric Use ▾
Pediatric Use The use of 3% and 5% Sodium Chloride Injection, USP in pediatric patients is based on clinical practice. (See DOSAGE AND ADMINISTRATION ) Plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes.
🧓 Geriatric Use ▾
Geriatric Use Clinical studies of 3% and 5% Sodium Chloride Injection, USP, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the 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.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug 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 Excessive administration of 3% and 5% Sodium Chloride Injection, USP may lead to hypernatremia (which can lead to CNS manifestations, including seizures, coma, cerebral edema and death) and sodium overload (which can lead to central and/or peripheral edema). When assessing an overdose, any additives in the solution must also be considered. The effects of an overdose may require immediate medical attention and treatment.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY 3% and 5% Sodium Chloride Injection, USP has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED 3% and 5% Sodium Chloride Injection, USP in VIAFLEX plastic container is available as follows: Code Size (mL) NDC Product Name 2B1353 500 0338-0054-03 3% Sodium Chloride Injection, USP 2B1373 500 0338-0056-03 5% Sodium Chloride Injection, USP Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F); brief exposure up to 40°C /104°F does not adversely affect the product.
📋 Description ▾
DESCRIPTION 3% and 5% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, hypertonic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. The pH may have been adjusted with hydrochloric acid. It contains no antimicrobial agents.
Composition, ionic concentration, osmolarity, and pH are shown in Table 1 . Table 1 size (mL) Composition (g/L) Ionic Concentration (mEq/L) Normal physiological osmolarity range is approximately 280 to 310 mOsmol/L. Osmolarity (mOsmol/L) (calc) pH Sodium Chloride USP (NaCl) Sodium Chloride 3% Sodium Chloride Injection, USP 500 30 513 513 1027 5.0 (4.5 to 7.0) 5% Sodium Chloride Injection, USP 500 30 856 856 1711 5.0 (4.5 to 7.0) The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic).
The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.
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) | — 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 | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |