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Sodium Chloride 3 g/100mL Injection, Solution — NDC 00338-0054-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sodium Chloride 3 g/100mL Injection, Solution — NDC 0338-0054-03 (Billing 00338-0054-03)

by Baxter Healthcare Corporation · 24 BAG in 1 CARTON / 500 mL in 1 BAG

This is a package of Sodium Chloride 3 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 00338-0054-03
🏷️ FDA NDC (as labeled) 0338-0054-03 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 0338-0054-03 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0338 labeler · 0054 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 0338005403 9
Medicaid fills, this package
532 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Sodium Chloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Aug 17, 2026 — Presence of particulate matter: Particulates identified as fiberglass (Baxter Healthcare Corporation) · FDA recall D-0849-2026
Class II · Apr 2, 2026 — Lack of Assurance of Sterility (Huons Co., Ltd.) · FDA recall D-0531-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0427-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0424-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0432-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0426-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0338-0054-03
Product NDC 0338-0054
11-digit billing NDC 00338005403
NCPDP billing unit ML — per mL (volume)
RxCUI 730781, 730782
UNII 451W47IQ8X
Application # NDA019022
SPL Set ID 181705c7-40e4-4d7d-b9ea-ada99380e7a9
Established class (EPC) Osmotic Laxative
Mechanism of action Osmotic Activity
Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1983-11-01
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance SODIUM CHLORIDE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 79750010002030
GPI class Sodium Chloride
GCN Seq No 001211
GCN 02964
HICL code 008256
Ingredient (HICL) Sodium Chloride 3 %
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C1
Therapeutic class — intermediate (HIC2) Drugs Affecting Electrolyte Balance
HIC3 code C1B
Therapeutic class — specific (HIC3) Sodium/Saline Preparations
AHFS code 40:12.00.00
AHFS class Replacement Preparations
FDB label name SODIUM CHLORIDE 3% IV SOLN
FDB brand name Sodium Chloride
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 001211
  • GCN: 02964
  • GPI-14 (Medi-Span): 79750010002030
  • HICL (First Databank): 008256
  • AHFS class code: 40:12.00.00
  • RxCUI (RxNorm): 730781
Why two NDCs? The FDA registers this code as 0338-0054-03 — a 4-4-2 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 labeler segment → 00338-0054-03. 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 Sodium class.

Drug family (ATC) Sodium, Salt solutions, 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.

Clinical

Label name SODIUM CHLORIDE 3% IV SOLN Ingredient Sodium Chloride 3 %
📗 Our plain-language guide HelloPharmacist
  • 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?
📖 Read our full Sodium Chloride guide →
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.

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 $2.19 $26,253.60 / 12000 ml
Medicare drug plans payPart D · Q2 2026 $0.0144 $172.80 / 12000 ml
Medicare Part B allowsASP · J7799 No ASP payment limit on file for J7799 this quarter.
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.

Billing & reimbursement

FDA NDC (as labeled)0338-0054-03
11-digit billing NDC00338-0054-03
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ7799
DescriptorNOC DRUGS, OTHER THAN INHALATION DRUGS, ADMINISTERED THROUGH DME
Billing units / pkg1 units
How the units are derivedThis package is 500 ML; the HCPCS unit is 1 EA, so one package = 1 billing unit.
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00338-0054-03 You're viewing this Main listing 24 BAG in 1 CARTON / 500 mL in 1 BAG 1983-11-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sodium Chloride 3 g/100mL 00264-7805-10 B. 500 ml — AP FDA listed —
Sodium Chloride 3 g/100mLthis 00338-0054-03 Baxter 500 ml — AP FDA listed —
3% Sodium Chloride 3 g/100mL 17271-0703-06 Becton 500 ml — AP FDA listed —
Sodium Chloride 3 g/100mL 63323-0530-75 Fresenius 500 ml — AP FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
1983
On the market since
Nov 1983
📍
2026
Currently FDA-listed
43 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

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?
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.

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 QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 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.

Manufacturer & labeler

LabelerBaxter Healthcare Corporation
Application holderBAXTER HEALTHCARE CORP
FDA applicationNDA019022 (NDA)
Labeler code00338
First marketedNov 1983
Product typeHuman Prescription Drug
Portfolio283 products on file

More NDCs from Baxter Healthcare Corporation labeler code 00338

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.

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 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 19 words ▾

INDICATIONS AND USAGE 3% and 5% Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.

⏱️ Dosage and Administration 190 words ▾

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 3 words ▾

CONTRAINDICATIONS None known.

⚠️ Warnings ~1 min read ▾

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 90 words ▾

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 78 words ▾

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 78 words ▾

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 48 words ▾

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 144 words ▾

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 64 words ▾

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 32 words ▾

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 74 words ▾

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 207 words ▾

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.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed. Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.

Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers. 3% and 5% Sodium Chloride Injection, USP is hypertonic with an osmolarity of 1027 mOsmol/L and 1711 mOsmol/L, respectively.

Administration of hypertonic solutions may cause venous damage and thus should be administered through a large vein, for rapid dilution. Do not mix or administer 3% and 5% Sodium Chloride Injection, USP solutions through the same administration set with whole blood or cellular blood components. Rapid correction of hypo- and hypernatremia is potentially dangerous (risk of serious neurologic complications).

Dosage, rate, and duration of administration should be determined by a physician experienced in intravenous fluid therapy. 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 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. Nursing Mothers It is not known whether this drug is excreted present in human milk.

Because many drugs are excreted present in human milk, caution should be exercised when 3% and 5% Sodium Chloride Injection, USP is administered to a nursing woman. 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 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.

🍼 Nursing Mothers 42 words ▾

Nursing Mothers It is not known whether this drug is excreted present in human milk. Because many drugs are excreted present in human milk, caution should be exercised when 3% and 5% Sodium Chloride Injection, USP is administered to a nursing woman.

📄 Package Label / Principal Display Panel ~2 min read ▾

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL LOT EXP 2B1353 NDC 0338-0054-03 Hypertonic Saline 3% Sodium Chloride Injection USP 500mL EACH 100 mL CONTAINS 3 g SODIUM CHLORIDE USP pH MAY HAVE BEEN ADJUSTED WITH HYDROCHLORIC ACID pH 5.0 (4.5 TO 7.0) mEq/L SODIUM 513 CHLORIDE 513 OSMOLARITY 1027 mOsmol/L (CALC) HYPERTONIC MAY CAUSE VEIN DAMAGE STERILE NONPYROGENIC SINGLE DOSE CONTAINER ADDITIVES MAY BE INCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE WHEN INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE MIX THOROUGHLY DO NOT STORE DOSAGE INTRAVENOUSLY AS DIRECTED BY A PHYSICIAN SEE DIRECTIONS CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND MUST NOT BE USED IN SERIES CONNECTIONS DO NOT USE UNLESS SOLUTION IS CLEAR RX ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT VIAFLEX CONTAINER PL 146 PLASTIC BAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC FOR PRODUCT INFORMATION 1-800-933-0303 Baxter Logo BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA LOT EXP 2B1373 NDC 0338-0056-03 Hypertonic Saline 5% Sodium Chloride Injection USP 500mL EACH 100 mL CONTAINS 5 g SODIUM CHLORIDE USP pH MAY HAVE BEEN ADJUSTED WITH HYDROCHLORIC ACID pH 5.0 (4.5 TO 7.0) mEq/L SODIUM 856 CHLORIDE 856 OSMOLARITY 1711 mOsmol/L (CALC) HYPERTONIC MAY CAUSE VEIN DAMAGE STERILE NONPYROGENIC SINGLE DOSE CONTAINER ADDITIVES MAY BE INCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE WHEN INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE MIX THOROUGHLY DO NOT STORE DOSAGE INTRAVENOUSLY AS DIRECTED BY A PHYSICIAN SEE DIRECTIONS CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND MUST NOT BE USED IN SERIES CONNECTIONS DO NOT USE UNLESS SOLUTION IS CLEAR RX ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT VIAFLEX CONTAINER PL 146 PLASTIC BAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC FOR PRODUCT INFORMATION 1-800-933-0303 Baxter Logo BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA 500 mL Container Label Representative Container Label 0338-0056-03

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
532
Units reimbursed last 4 qtrs
137K
Gross reimbursed last 4 qtrs
$299.6K
Avg / prescription
$563.23
Avg / unit
$2.1878
Latest quarter Q1 2026
161Rx
Fee-for-service vs managed care ⓘ
98% FFS
Fee-for-service · 519 Rx Managed care · 13 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: 11,039 units · 975 per 100k residents MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: 1,794 units · 128 per 100k residents NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 109,469 units · 281 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 11,000 units · 178 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 3,654 units · 59.1 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
59.1975
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Montana 975 /100k
2 California 281 /100k
3 Missouri 178 /100k
4 New Hampshire 128 /100k
5 Maryland 59.1 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Sodium Chloride — the program that covers self-administered drugs. 9 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 Chloride. 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
$2.42M
Claims incl. refills
105K
Beneficiaries
50.3K
Spend / beneficiary
$48.15
Spend / claim
$23.08
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.

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 ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Baxter Healthcare Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Baxter Healthcare Corporation 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J7799 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
← 00338-0051-44 · Baxter 00338-0056-03 · Baxter →
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.