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Sodium chloride 9 mg/mL Injection, Solution — NDC 65219-0218-50 package photo

Sodium chloride 9 mg/mL Injection, Solution

by Fresenius Kabi USA, LLC · 60 BAG in 1 CASE (65219-218-50) / 50 mL in 1 BAG (65219-218-01)
NDC 65219-0218-50
🏷️ FDA NDC (as labeled) 65219-218-50 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
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) 65219-218-50
Product NDC 65219-218
11-digit billing NDC 65219021850
NCPDP billing unit ML — per mL (volume)
RxCUI 1807631, 1807632, 1807633, 1807634
UNII 451W47IQ8X
Application # ANDA207310
SPL Set ID d98bf9f7-30ec-4927-a577-cabad192cb18
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 ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-09-19
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance SODIUM CHLORIDE
GPI-14 79750010002021
GCN Seq No 001210
GCN 02962
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 65219-218-50 — a 5-3-2 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 product segment → 65219-0218-50. 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

LabelerFresenius Kabi USA, LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationANDA207310 (ANDA)
Labeler code65219
First marketedSep 2017
Product typeHuman Prescription Drug
Portfolio554 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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.

1 inactive ingredient listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.0121 $36.30 / 3000 ml
Medicare Part B allowsASP · J7040 $1.350 / J7040 unit —
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)65219-218-50
11-digit billing NDC65219-0218-50
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ7040
DescriptorINFUSION, NORMAL SALINE SOLUTION, STERILE (500 ML = 1 UNIT)
Billing units / pkg0 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 9 mg/mL 00409-4888-10 Hospira, 25 vials $0.088 AP Availability likely —
Sodium Chloride 9 mg/mL 00264-1800-31 B. 50 ml — AP FDA listed —
Sodium Chloride 9 g/1000mL 00338-0049-01 Baxter 150 ml — — Discontinued —
Sodium Chloride 450 mg/100mL 00338-0164-01 Baxter 50 ml — AP FDA listed —
Sodium Chloride 450 mg/50mL 00338-0182-04 Baxter 50 ml — AP FDA listed —
Sodium Chloride 450 mg/50mL 00338-0192-04 Baxter 50 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 00338-0553-11 Baxter 50 ml — AP FDA listed —
Sodium Chloride 450 mg/50mL 00338-9151-30 Baxter 50 ml — AP FDA listed —
Sodium Chloride 9 g/1000mL 00338-9657-75 Baxter 50 ml — — FDA listed —
Sodium Chloride 9 g/1000mL 00338-9659-75 Baxter 50 ml — — FDA listed —
Sodium Chloride 450 mg/50mL 00338-9660-40 Baxter 50 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 00404-9954-20 Henry 1 vial — AP FDA listed —
Sodium Chloride 9 mg/mL 00487-4301-05 Nephron 50 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 00990-7984-13 ICU 48 pouches — AP FDA listed —
Sodium chloride 9 mg/mL 17271-0701-02 Becton 50 ml — AP FDA listed —
Sodium chloride 9 mg/mL 17271-0771-02 BECTON 50 ml — AP FDA listed —
0.9% Sodium Chloride 9 mg/mL 51662-1359-01 HF 50 ml — AP FDA listed —
Sodium chloride 9 mg/mL 63323-0623-53 Fresenius 50 ml — AP FDA listed —
Sodium chloride 9 mg/mLthis 65219-0218-50 Fresenius 50 ml — AP FDA listed —
Sodium chloride 9 mg/mL 65219-0466-60 Fresenius 50 ml — AP FDA listed —
Sodium Chloride 9 g/1000mL 70512-0841-06 SOLA 50 ml — AP FDA listed —
Sodium Chloride 9 g/1000mL 76297-0001-01 LABORATORIOS 500 ml — AP FDA listed —
Sodium Chloride 9 g/1000mL 79672-0613-10 Nextgen 50 ml — AP FDA listed —
Sodium Chloride 9 g/1000mL 81826-0001-01 CODAN 50 ml — AP FDA listed —
Polifleks .9 g/100mL 84879-0263-01 POLIFARMA 50 ml — — Discontinued —
Sodium Chloride 9 mg/mL 00264-9375-88 B. 10 ml — AP FDA listed —
0.9% Sodium Chloride 9 mg/mL 51662-1577-01 HF 500 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 63323-0186-02 Fresenius 25 vials — — FDA listed —
Sodium Chloride 9 mg/mL 63323-0632-40 Fresenius 1000 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 65219-0328-50 Fresenius 1000 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 65219-0432-85 Fresenius 500 ml — AP FDA listed —
Sodium chloride 9 mg/mL 65219-0468-50 Fresenius 100 ml — AP FDA listed —
Sodium chloride 9 mg/mL 65219-0470-30 Fresenius 250 ml — AP FDA listed —
Sodium chloride 9 mg/mL 65219-0472-20 Fresenius 500 ml — AP FDA listed —
Sodium chloride 9 mg/mL 65219-0474-10 Fresenius 1000 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 00404-9955-10 Henry 1 vial — — FDA listed —
Sodium chloride 9 mg/mL 65219-0222-25 Fresenius 250 ml — AP FDA listed —
Sodium chloride 9 mg/mL 65219-0224-50 Fresenius 500 ml — AP FDA listed —
Sodium chloride 9 mg/mL 65219-0220-10 Fresenius 100 ml — AP FDA listed —
Sodium chloride 9 mg/mL 65219-0282-10 Fresenius 1000 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 55154-9357-05 Cardinal 5 vials — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2017
On the market since
Sep 2017
📍
2026
Currently FDA-listed
9 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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

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

Medicare Part D (outpatient prescription) spending for Sodium 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
65219-0218-50 You're viewing this 60 BAG in 1 CASE (65219-218-50) / 50 mL in 1 BAG (65219-218-01) 2021-11-17 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 65219-218-50, 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: 65219-0218-50, written without dashes as 65219021850. 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 65219-0218-50, the first segment (65219) is the labeler code FDA assigned to Fresenius Kabi USA, LLC; the middle segment (0218) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (50) 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 Fresenius Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Fresenius Kabi USA, LLC 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 J7040 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 27 words ▾

INDICATIONS AND USAGE Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.

⏱️ Dosage and Administration 61 words ▾

DOSAGE AND ADMINISTRATION The dose is dependent upon the age, weight and clinical condition of the patient. Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (see PRECAUTIONS ).

⛔ Contraindications 3 words ▾

CONTRAINDICATIONS None known.

⚠️ Warnings 117 words ▾

WARNINGS Sodium Chloride Injection, USP 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. The intravenous administration of Sodium Chloride Injection, USP can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutive states is inversely proportional to the electrolyte concentration of the injections.

The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections. In patients with diminished renal function, administration of Sodium Chloride Injection, USP may result in sodium retention.

🤒 Adverse Reactions 83 words ▾

ADVERSE REACTIONS Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. 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. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~2 min read ▾

DRUG INTERACTIONS Caution must be exercised in the administration of Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotropin. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies have not been performed with Sodium Chloride Injection, USP to evaluate the potential for carcinogenesis, mutagenesis or impairment of fertility. Pregnancy: Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with Sodium Chloride Injection, USP.

It is also not known whether Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride Injection, USP should be given to a pregnant woman only if clearly needed. Labor and Delivery Studies have not been conducted to evaluate the effects of Sodium Chloride Injection, USP on labor and delivery.

Caution should be exercised when administrating this drug during labor and delivery. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sodium Chloride Injection, USP is administered to a nursing mother.

Pediatric Use The use of Sodium Chloride Injection, USP in pediatric patients is based on clinical practice. 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 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 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 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. Do not administer unless solution is clear and container is undamaged. Discard unused portion.

🤰 Pregnancy 58 words ▾

Pregnancy: Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with Sodium Chloride Injection, USP. It is also not known whether Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride Injection, USP should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 40 words ▾

Pediatric Use The use of Sodium Chloride Injection, USP in pediatric patients is based on clinical practice. 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 153 words ▾

Geriatric Use Clinical studies of 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 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 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. Do not administer unless solution is clear and container is undamaged.

Discard unused portion.

🆘 Overdosage 26 words ▾

OVERDOSAGE In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures (see WARNINGS , PRECAUTIONS , and ADVERSE REACTIONS ).

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY When administered intravenously, the solution provides a source of water and electrolytes. Solutions which provide combinations of hypotonic or isotonic concentrations of sodium chloride are suitable for parenteral maintenance or replacement of water and electrolyte requirements. Isotonic concentrations of sodium chloride are suitable for parenteral replacement of chloride losses that exceed or equal the sodium loss.

Hypotonic concentrations of sodium chloride are suited for parenteral maintenance of water requirements when only small quantities of salt are desired. A hypertonic concentration of sodium chloride may be used to repair severe salt depletion syndrome. Sodium chloride in water dissociates to provide sodium (Na + ) and chloride (Cl - ) ions.

Sodium (Na + ) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl - ) 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 (Cl - ) are largely under the control of the kidney which maintains a balance between intake and output.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirements range from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms.

Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na + ) plays a major role in maintaining physiologic equilibrium.

📦 How Supplied / Storage and Handling 175 words ▾

HOW SUPPLIED 0.9% Sodium Chloride Injection, USP is supplied in single-dose flexible plastic containers as follows: Product Code Unit of Sale Strength Each 232150 NDC 65219-218-50 Package of 60 free flex ® + bags 0.9% (450 mg per 50 mL) (9 mg/mL) NDC 65219-218-01 50 mL in a 100 mL free flex ® + bag 232200 NDC 65219-220-10 Package of 50 free flex ® + bags 0.9% (900 mg per 100 mL) (9 mg/mL) NDC 65219-220-01 100 mL free flex ® + bag 232225 65219-222-25 Package of 30 free flex ® + bags 0.9% (2,250 mg per 250 mL) (9 mg/mL) 65219-222-01 250 mL free flex ® + bag 232250 65219-224-50 Package of 20 free flex ® + bags 0.9% (4,500 mg per 500 mL) (9 mg/mL) 65219-224-01 500 mL free flex ® + bag Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect from freezing. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.

Lake Zurich, IL 60047 www.fresenius-kabi.com/us Revised: July 2024 Fresenius Kabi Logo

📋 Description ~1 min read ▾

DESCRIPTION 0.9% Sodium Chloride Injection, USP solution is sterile and nonpyrogenic. It is a parenteral solution containing sodium chloride in water for injection intended for intravenous administration. For 0.9% Sodium Chloride Injection, USP, each 100 mL contains 900 mg sodium chloride in water for injection.

Electrolytes per 1,000 mL: sodium 154 mEq; chloride 154 mEq. The osmolarity is 308 mOsmol/L (calc.). The pH in the 100 mL and smaller containers is 6.0; for the 250 mL and larger containers, the pH is 5.6.

The pH range is 4.5 to 7.0 for all containers. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded.

The solution is a parenteral fluid and electrolyte replenisher. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for injection, USP is chemically designated H 2 O.

The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag). The free flex ® + bag has a needle-free injection port and can accept standard luer lock syringes to add medication. The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly.

Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.

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