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Sodium Chloride 900 mg/100mL Injection, 50 mL

by Baxter Healthcare Corporation · 50 mL in 1 BAG (0338-0553-11)
NDC 00338-0553-11
🏷️ FDA NDC (as labeled) 0338-0553-11 billing pads the labeler segment with a zero
This package
Contains50 mL Medicaid pays$0.2102 / unit · 12 mo Per package$0.21 / 1 bag · Medicaid Pack sizes2 compare ↓
Also priced by: Part D plans $0.0121/unit — full pricing hub ↓
Also comes in: 100 ml 00338-0553-18
Rx only Brand 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

⚠️
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 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-0433-2026
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-0425-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0429-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0431-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 0338-0553-11
Product NDC 0338-0553
11-digit billing NDC 00338055311
NCPDP billing unit ML — per mL (volume)
RxCUI 1807631, 1807632
UNII 451W47IQ8X
Application # NDA020178
SPL Set ID fbc01464-8885-4075-af41-911ffec5ae92
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 1992-12-07
Route INTRAVENOUS
Dosage form INJECTION
Substance SODIUM CHLORIDE
GPI-14 79750010002021
GPI class Sodium Chloride
GCN Seq No 060476
GCN 26637
HICL code 008255
Ingredient (HICL) 0.9 % Sodium Chloride
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 0.9% SOLUTION
FDB brand name Sodium Chloride
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 0338-0553-11 — 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 → 00338-0553-11. 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.

🏭 Manufacturer & labeler

LabelerBaxter Healthcare Corporation
Application holderBAXTER HEALTHCARE CORP
FDA applicationNDA020178 (NDA)
Labeler code00338
First marketedDec 1992
Product typeHuman Prescription Drug
Portfolio281 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 CHLORIDE 0.9% SOLUTION Ingredient 0.9 % Sodium Chloride
📗 Our plain-language guide HelloPharmacist
  • 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?
📖 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.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured 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?
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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.2102 $0.21 / 1 bag
Medicare drug plans payPart D · Q2 2026 $0.0121 $0.01 / 1 bag
Medicare Part B allowsASP · A4216 No ASP payment limit on file for A4216 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)0338-0553-11
11-digit billing NDC00338-0553-11
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeA4216
DescriptorSTERILE WATER, SALINE AND/OR DEXTROSE, DILUENT/FLUSH, 10 ML
Billing units / pkg0.1 units
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sodium Chloride 900 mg/100mL 00409-7101-02 Hospira, 24 pouches $0.021 AP Availability likely —
Sodium Chloride 900 mg/100mL 51662-1522-01 HF 500 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 00338-0186-04 Baxter 100 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 00338-0162-01 Baxter 100 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 00990-7984-13 ICU 48 pouches — AP FDA listed —
Sodium Chloride 900 mg/100mL 00338-0196-04 Baxter 100 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 00338-9159-30 Baxter 100 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 00338-0166-01 Baxter 100 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 00338-9662-35 Baxter 100 ml — AP FDA listed —
Sodium Chloride 900 mg/100mLthis 00338-0553-11 Baxter 50 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 46163-0300-10 Fresenius 1000 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 49230-0300-10 Fresenius 1000 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 00990-7983-02 ICU 24 pouches — 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

🏛️
1992
On the market since
Dec 1992
📍
2026
Currently FDA-listed
34 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.

🗺️ 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 00338-0553-11, 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 – Q4 2025 · 4 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
29.6K
Units reimbursed last 4 qtrs
8.7M
Gross reimbursed last 4 qtrs
$1.83M
Avg / prescription
$61.80
Avg / unit
$0.2102
Latest quarter Q4 2025
6.4KRx
Fee-for-service vs managed care ⓘ
51% FFS 49% MCO
Fee-for-service · 15,174 Rx Managed care · 14,456 Rx
State Medicaid map
Alaska: no data reported AK Maine: 2,750 units · 197 per 100k residents ME Washington: 13,650 units · 175 per 100k residents WA Idaho: 108,750 units · 5,537 per 100k residents ID Montana: 65,703 units · 5,804 per 100k residents MT North Dakota: no data reported ND Minnesota: 133,516 units · 2,327 per 100k residents MN Wisconsin: no data reported WI Michigan: 32,950 units · 328 per 100k residents MI New York: 1,181,850 units · 6,039 per 100k residents NY Vermont: no data reported VT New Hampshire: 119,773 units · 8,543 per 100k residents NH Oregon: 22,800 units · 539 per 100k residents OR Nevada: 18,100 units · 567 per 100k residents NV Wyoming: 4,500 units · 771 per 100k residents WY South Dakota: 1,492 units · 162 per 100k residents SD Iowa: 65,030 units · 2,028 per 100k residents IA Illinois: 46,200 units · 368 per 100k residents IL Indiana: 330,700 units · 4,819 per 100k residents IN Ohio: 503,012 units · 4,268 per 100k residents OH Pennsylvania: 217,750 units · 1,680 per 100k residents PA New Jersey: 380,303 units · 4,094 per 100k residents NJ Massachusetts: 58,766 units · 839 per 100k residents MA California: 1,690,363 units · 4,338 per 100k residents CA Utah: 1,038,900 units · 30,404 per 100k residents UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 437,501 units · 7,061 per 100k residents MO Kentucky: 145,672 units · 3,219 per 100k residents KY West Virginia: no data reported WV Virginia: 27,093 units · 311 per 100k residents VA Maryland: 75,678 units · 1,225 per 100k residents MD Connecticut: 28,500 units · 788 per 100k residents CT Rhode Island: no data reported RI Arizona: 27,630 units · 372 per 100k residents AZ New Mexico: 222,149 units · 10,508 per 100k residents NM Kansas: no data reported KS Arkansas: 101,921 units · 3,323 per 100k residents AR Tennessee: 231,300 units · 3,246 per 100k residents TN North Carolina: 155,172 units · 1,432 per 100k residents NC South Carolina: 20,200 units · 376 per 100k residents SC Delaware: no data reported DE Oklahoma: 45,700 units · 1,128 per 100k residents OK Louisiana: 8,800 units · 192 per 100k residents LA Mississippi: 70,398 units · 2,394 per 100k residents MS Alabama: 18,200 units · 356 per 100k residents AL Georgia: 4,600 units · 41.7 per 100k residents GA D.C.: no data reported DC Hawaii: 4,320 units · 301 per 100k residents HI Texas: 626,617 units · 2,054 per 100k residents TX Florida: 423,320 units · 1,872 per 100k residents FL
Units reimbursed · per 100k residents
41.730,404
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 Utah 30,404 /100k
2 New Mexico 10,508 /100k
3 New Hampshire 8,543 /100k
4 Missouri 7,061 /100k
5 New York 6,039 /100k
6 Montana 5,804 /100k
7 Idaho 5,537 /100k
8 Indiana 4,819 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 ml00338-0553-18 88,073 Rx · $9,544,639
5 ml this page00338-0553-11 29,630 Rx · $1,831,023
Drug total (last 4 qtrs): 117,703 Rx · 62,607,271 units · $11,375,662 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00338-0553-11 You're viewing this 50 mL in 1 BAG (0338-0553-11) 1992-12-07 Active
00338-0553-18 100 mL in 1 BAG (0338-0553-18) 1992-12-07 Active

You're viewing the smallest of 2 pack sizes for this product.

This pack accounts for about 25% of this product's recent Medicaid fills; most go to the 1 ml pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 00338-0553-11?
NDC 00338-0553-11 contains 50 mL — 50 ml in 1 bag.
What is the difference between NDC 00338-0553-11 and NDC 00338-0553-18?
Both are Sodium Chloride 900 mg/100mL Injection — the drug itself is identical. NDC 00338-0553-11 is the 50 mL package, while NDC 00338-0553-18 is the 100 ml package.
What NDC number is used to bill for this package of Sodium Chloride 900 mg/100mL Injection?
Bill NDC 00338-0553-11 — the 11-digit billing format is 00338055311. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 — Not published for this NDC No photo available yet for this listing.
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) ✓ 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 FDA registers it as 0338-0553-11, 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: 00338-0553-11, written without dashes as 00338055311. 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 00338-0553-11, the first segment (00338) is the labeler code FDA assigned to Baxter Healthcare Corporation; the middle segment (0553) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (11) 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 Baxter Healthcare Corporation. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 100 ml (00338-0553-18). Each has its own NDC and its own page — see the package list near the top of this page.
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 A4216 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.

📄 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
🎯 Indications and Usage 46 words ▾

INDICATIONS AND USAGE 0.9% Sodium Chloride Injection, USP is indicated as a source of water and electrolytes and may also be used as diluent for reconstitution of a powdered or liquid (up to 10 mL) drug product packaged in a vial with a 20 mm closure.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION Important Administration Instructions • 0.9 % Sodium Chloride Injection, USP is intended for intravenous administration using sterile equipment. • Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container. • Set the vent to the closed position on a vented intravenous administration set to prevent air embolism. • Use a dedicated line without any connections to avoid air embolism. • Do not pressurize intravenous solutions contained in flexible plastic containers to increase flow rates in order to avoid air embolism due to incomplete evacuation of residual air in the container. • Prior to infusion, visually inspect the solution for particulate matter and discoloration.

The solution should be clear and there should be no precipitates. Do not administer unless solution is clear, and container is undamaged. Dosing Information The choice of product, dosage, volume, rate, and duration of administration is dependent upon the age, weight and clinical condition of the patient and concomitant therapy, and administration should be determined by a physician experienced in intravenous fluid therapy.

Introduction of Additives Additives may be incompatible. Evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. Consult with a 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. After addition, if there is a discoloration and/or the appearance of precipitates, insoluble complexes or crystals, do not use.

Do not store solutions containing additives. Discard any unused portion.

⛔ Contraindications 3 words ▾

CONTRAINDICATIONS None known.

⚠️ Warnings ~2 min read ▾

WARNINGS Hypersensitivity Hypersensitivity and infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus have been reported with 0.9% 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.

Electrolyte Imbalances Fluid Overload Depending on the volume and rate of infusion, and the patient’s underlying clinical condition, the intravenous administration of Sodium Chloride Injection, USP can cause fluid distrurbance such as overhydration/hypervolemia and congested states, including pulmonary congestion and edema. Avoid 0.9% Sodium Chloride Injection, USP in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, fluid balance, electrolyte concentrations, and acid base balance, as needed and especially during prolonged use.

Hyponatremia 0.9% Sodium Chloride Injection, USP may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury.

The risk of hospital-acquired hyponatremia is increased in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH) treated with high volume of Sodium Chloride Injection, USP. The risk for hyponatremia is increased in pediatric patients, elderly patients, postoperative patients, in those with psychogenic polydipsia, and in patients treated with medications that increase the risk of hyponatremia (such as diuretics, certain antiepileptic and psychotropic medications).

See DRUG INTERACTIONS . Patients at increased risk for developing complications of hyponatremia such as hyponatremic encephalopathy, include pediatric patients , women (in particular pre-menopausal women), patients with hypoxemia, and patients with underlying central nervous system disease. Avoid 0.9% Sodium Chloride Injection, USP in patients with or at risk for hyponatremia.

If use cannot be avoided, monitor serum sodium concentrations. Rapid correction of hyponatremia is potentially dangerous with risk of serious neurologic complications. Brain adaptations reducing risk of cerebral edema make the brain vulnerable to injury when chronic hyponatremia is too rapidly corrected, which is known as osmotic demyelination syndrome (ODS).

To avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and signs of neurologic complications. Hypernatremia Hypernatremia may occur with Sodium Chloride Injection, USP. Conditions that may increase the risk of hypernatremia, fluid overload and edema (central and peripheral), include patients with: primary hyperaldosteronism; secondary hyperaldosteronism associated with, for example, hypertension, congestive heart failure, liver disease (including cirrhosis), renal disease (including renal artery stenosis, nephrosclerosis); and pre-eclampsia.

Certain medications, such as corticosteroids or corticotropin, may also increase risk of sodium and fluid retention, see DRUG INTERACTIONS . Avoid 0.9% Sodium Chloride Injection, USP in patients with, or at risk for, hypernatremia. If use cannot be avoided, monitor serum sodium concentrations.

Rapid correction of hypernatremia is potentially dangerous with risk of serious neurologic complications. Excessively rapid correction of hypernatremia is also associated with a risk for serious neurologic complications such as osmotic demyelination syndrome (ODS) with risk of seizures and cerebral edema. For use only with a single dose powdered or liquid (up to 10 mL) drug vial with a 20 mm closure.

Do not administer unless drug is completely dissolved and drug vial is empty. Do not remove drug vial at any time…

🤒 Adverse Reactions 161 words ▾

ADVERSE REACTIONS Post-Marketing Adverse Reactions The following adverse reactions have been identified during postapproval use of 0.9% Sodium Chloride Injection, USP. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been reported in the post-marketing experience during use of 0.9% Sodium Chloride Injection, USP and include the following: Hypersensitivity reactions : hypersensitivity/infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus.

General disorders and administration site condition s: infusion site reactions, such as infusion site erythema, injection site streaking, burning sensation, and infusion site urticaria. Metabolism and nutrition disorders : hypernatremia, hyperchloremic metabolic acidosis, and hyponatremia, which may be symptomatic. Nervous System Disorders : Hyponatremic encephalopathy.

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 203 words ▾

Drug Interactions Other Products that Affect Fluid and/or Electrolyte Balance Administration of Sodium Chloride Injection, USP to patients treated concomitantly with drugs associated with sodium and fluid retention,- may increase the risk of hypernatremia and volume overload. Avoid use of Sodium Chloride Injection, USP in patients receiving such products, such as corticosteroids or corticotropin. If use cannot be avoided, monitor serum electrolytes, fluid balance and acid-base balance.

Lithium Renal sodium and lithium clearance may be decreased during during administration of Sodium Chloride Injection, USP. Monitor serum may result in increased lithium concentrations during concomitant use. Renal sodium and lithium clearance may be increased during administration of Sodium Chloride Injection, USP.

Monitor serum lithium concentrations during concomitant use. Other Drugs that Increase the Risk of Hyponatremia Administration of 0.9% Sodium Chloride Injection, USP in patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia. Avoid use of 0.9% Sodium Chloride Injection, USP in patients receiving products, such as diuretics, and certain antiepileptic and psychotropic medications.

Drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids. If use cannot be avoided, monitor serum sodium concentrations.

🤰 Pregnancy 69 words ▾

Pregnancy There are no adequate and well controlled studies with Sodium Chloride Injection, USP, in pregnant women and animal reproduction studies have not been conducted with this drug. Therefore, it is not known whether Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman. Sodium Chloride Injection, USP should be given during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 86 words ▾

Pediatric Use The use of Sodium Chloride Injection, USP in pediatric patients is based on clinical practice. (See DOSAGE AND ADMINISTRATION .) Closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes. In very low birth weight infants, excessive or rapid administration of Sodium Chloride Injection, USP may result in increased serum osmolality and risk of intracerebral hemorrhage.

Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy.

🧓 Geriatric Use 89 words ▾

Geriatric Use Geriatric patients are at increased risk of developing electrolyte imbalances. Sodium Chloride Injection, USP 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. Therefore, 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.

Consider monitoring renal function in elderly patients.

🆘 Overdosage 94 words ▾

OVERDOSAGE Excessive administration of: • 0.9% Sodium Chloride Injection, USP can cause hypernatremia. • 0.9% Sodium Chloride Injection, USP can cause fluid overload (which can lead to pulmonary and/or peripheral edema). See WARNINGS and ADVERSE REACTIONS . 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. Interventions include discontinuation of Sodium Chloride Injection, USP administration, dose reduction, and other measures as indicated for the specific clinical constellation (e.g., monitoring of fluid balance, electrolyte concentrations and acid base balance).

🧬 Clinical Pharmacology 29 words ▾

CLINICAL PHARMACOLOGY 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 48 words ▾

HOW SUPPLIED 0.9% Sodium Chloride Injection, USP in MINI-BAG Plus Container is available as follows: Code Size (mL) NDC 2B0042 50 0338-0553-11 2B0043 100 0338-0553-18 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).

📋 Description ~1 min read ▾

DESCRIPTION 0.9% Sodium Chloride Injection, USP in the MINI-BAG Plus Container is a sterile, nonpyrogenic solution for intravenous administration after admixture with a single dose powdered or liquid (up to 10 mL) drug vial. It contains no antimicrobial agents. The nominal pH is 5.0 (4.5 to 7.0).

Each 100 mL contains 900 mg of Sodium Chloride, USP (NaCl). The osmolarity is 308 mOsmol/L (calculated). It contains 154 mEq/L sodium and 154 mEq/L chloride.

The MINI-BAG Plus Container is a standard diluent container with an integral drug vial adaptor. It allows for drug admixture after connection to a single dose powdered or liquid (up to 10 mL) drug vial having a 20 mm closure . A breakaway seal in the tube between the vial adaptor and the container is broken to allow transfer of the diluent into the vial and reconstitution of the drug.

The MiniBag Plus product mechanically prohibits the transfer of contaminants into and out of the system during and after docking, minimizing environmental and personal exposure. The reconstituted drug is then transferred from the vial into the container diluent and mixed to result in an admixture for delivery to the patient. The VIAFLEX Plastic Container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic).

Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

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 chemical components from the plastic in very small amounts. However, biological testing was supportive of the safety of the plastic container materials.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00338-0551-11 · Baxter 00338-0603-03 · 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.