NDC 00019-1188-27 — SODIUM CHLORIDE .9 mg/mL Injection

🆔 Identity & classification

FDA NDC (as labeled) 0019-1188-27

Product NDC 0019-1188

11-digit billing NDC 00019118827

NCPDP billing unit ML — per mL (volume)

UNII 451W47IQ8X

UPC 0300191188816

Application # NDA021569

SPL Set ID e4540d03-06b4-4b4d-b859-75c13e5c20dd

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 2012-09-01

Route INTRAVASCULAR

Dosage form INJECTION

Substance SODIUM CHLORIDE

GPI-14 79750010102024

GPI class Sodium Chloride Flush

GCN Seq No 001218

GCN 03020

HICL code 045574

Ingredient (HICL) Sodium Chloride 0.9 % (Flush)

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 40:36.00.00

AHFS class Irrigating Solutions

FDB label name SODIUM CHLORIDE 0.9% (PWR INJ)

FDB brand name Sodium Chloride

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 0019-1188-27 — 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 → 00019-1188-27. 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.

🏭 Manufacturer & labeler

LabelerLiebel-Flarsheim Company LLC

Application holderLIEBEL-FLARSHEIM CO LLC

FDA applicationNDA021569 (NDA)

Labeler code00019

First marketedSep 2012

Product typeHuman Prescription Drug

Portfolio7 products on file

🔎 All NDCs from Liebel-Flarsheim Company LLC

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% (PWR INJ) Ingredient Sodium Chloride 0.9 % (Flush)

📗 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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Sodium Chloride — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Sodium Chloride (17 interactions) — ranked by severity →

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 system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · A4217	No ASP payment limit on file for A4217 this quarter.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Try another pack size: 125 mL

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)0019-1188-27

11-digit billing NDC00019-1188-27

Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)

HCPCS J-codeA4217

DescriptorSTERILE WATER/SALINE, 500 ML

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Sodium Chloride .9 mg/mLthis 00019-1188-27	Liebel-Flarsheim	1 syringe	—	—	FDA listed	—

About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.

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

🏛️

2012

On the market since

Sep 2012

📍

2026

Currently FDA-listed

14 years listed

🔒

·

No generic listed yet

brand only

ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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 NDC	Description	Marketing start	Status
00019-1188-27 You're viewing this	20 BOX in 1 CARTON (0019-1188-27) / 1 SYRINGE, PLASTIC in 1 BOX / 125 mL in 1 SYRINGE, PLASTIC	2012-09-01	Active
00019-1188-81	20 BOX in 1 CARTON (0019-1188-81) / 1 SYRINGE, PLASTIC in 1 BOX / 125 mL in 1 SYRINGE, PLASTIC	2012-09-01	Active

Pack size FAQ

What quantity is in NDC 00019-1188-27?

NDC 00019-1188-27 is listed by the FDA — 20 box in 1 carton / 1 syringe, plastic in 1 box / 125 ml in 1 syringe, plastic.

What NDC number is used to bill for this package of SODIUM CHLORIDE .9 mg/mL Injection?

Bill NDC 00019-1188-27 — the 11-digit billing format is 00019118827. 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	✓ 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	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	✓ Available
Medicaid utilization (CMS SDUD)	— 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 0019-1188-27, 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: 00019-1188-27, written without dashes as 00019118827. 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 00019-1188-27, the first segment (00019) is the labeler code FDA assigned to Liebel-Flarsheim Company LLC; the middle segment (1188) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (27) 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 Liebel-Flarsheim Company LLC. 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 1 syringe (00019-1188-81). 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?

Liebel-Flarsheim Company 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 A4217 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description

🎯 Indications and Usage 83 words ▾

1 INDICATIONS AND USAGE 125 mL Syringe: Sodium Chloride Injection USP 0.9% is indicated for use in flushing compatible contrast agents through Liebel-Flarsheim intravenous administration sets into indwelling intravascular access devices only when delivered by the following Liebel-Flarsheim power injectors: Angiomat ® , Illumena ® , Illumena ® Néo, CT9000 ® , CT9000 ® ADV, Optistat ® , Optivantage ® and Optistar Elite. For use in flushing compatible contrast agents through Liebel-Flarsheim intravenous administration sets into indwelling intravascular access devices ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION The 125 mL syringe are for single patient use only. Determine the volume of the saline flush for each patient individually based, in part, on the imaging procedure, the location of the vascular access device, the length of tubing between the Liebel-Flarsheim contrast agent power injector and the vascular access device and the recommendations made on the package insert for the contrast agent. Typical Sodium Chloride Injection USP 0.9% flush volumes following contrast agent administration in adults are 10 to 25 mL per injection at rates not to exceed 10 mL/sec.

Use of some Liebel-Flarsheim contrast agent power injectors allows for additional infusion of Sodium Chloride Injection USP 0.9% to maintain the patency of vascular access. Typical infusion rates used for this purpose are in the range of 0.5 to 1 mL per minute. Individualize infusion rates and flush volumes for each patient based on their body weight, fluid status and concomitant medical conditions.

Consult the Liebel-Flarsheim contrast agent power injector manual for proper use. For single patient use only. ( 2 ) Determine the volume of flush based on the imaging procedure, location of the vascular access device, length of tubing between power injector and vascular access device, and the contrast agent package insert.

( 2 ) Individualize the volume of flush based on body weight, fluid status and concomitant medical conditions. ( 2 ) Typical flush volumes for adults are 10 to 25 mL per injection at rates not to exceed 10 mL/sec. ( 2 ) May be used for additional infusion to maintain the patency of vascular access at a typical infusion rate of 0.5 to 1 mL per minute.

( 2 ) Do not use if packaging is damaged, wet, or not intact, if syringe or its tip cap shows signs of damage, leakage or displacement. Do not use if solution is hazy, cloudy, discolored, or contains particulate matter. ( 2 ) Use aseptic technique.

( 2 ) Expel residual air from the syringe and tubing prior to connection with the patient’s vascular access. ( 2 )

2.1Drug Handling Inspect the syringe for signs of break in sterility. Do not use if the syringe or its tip cap shows signs of damage, leakage or displacement. Do not use if the solution is hazy, cloudy, discolored or contains particulate matter.

Use aseptic technique. Expel residual air in both the syringe and tubing prior to connection with the patient’s vascular access. Instructions for assembly and inspection of the Sodium Chloride Injection USP 0.9% syringes prior to use are printed on this sheet.

2.2125 mL Syringe Assembly and Inspection NOTE: Exterior of syringe is not sterile. Contents of syringe and area under tip cap and piston ribs are sterile and should be treated accordingly. Remove syringe from carton and inspect the area around the tip cap and outside of piston for signs of leakage.

Do not use if leakage is observed. Load syringe into power injector. To remove tip cap from syringe, push in and twist off, then discard.

The area under the cap is sterile. Caution should now be used when handling. Next remove cap from luer locknut dust cover by twisting to break tamper evident seal.

Discard cap. Attach luer locknut to syringe by holding dust cover and screwing to the stop. Remove and discard dust cover when ready to attach sterile connector tubing.

Inspecting the 125 mL syringe Twisting off the 125 mL syringe cap Luer locknut detail Removing cap from luer locknut Attaching luer locknut to syringe

💊 Dosage Forms and Strengths 51 words ▾

3 DOSAGE FORMS AND STRENGTHS Sodium Chloride Injection USP (0.9%) a clear, colorless, odorless solution supplied in 125 mL prefilled syringes contents are sterile Supplied as a clear, colorless, odorless, sterile solution of Sodium Chloride 0.9% for intravenous administration ( 3 ) Supplied in 125 mL prefilled syringes ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None None ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Remove all air from the syringe and associated tubing prior to injection. ( 5.1 ) May cause fluid overload in patients with congestive heart failure, severe renal insufficiency, and in clinical states with edema, sodium retention, or hypernatremia. ( 5.3 ) Establish intravascular catheter patency prior to administration. ( 5.4 )

5.1Air Embolism Remove all air from the syringe and associated tubing prior to injection to avoid air embolus with the associated risk of stroke, organ ischemia and/or infarction, and death.

5.2Infectious Complications Use of a damaged syringe or failure to maintain aseptic technique may result in infection, sepsis and death [ see Dosage and Administration (2) ].

5.3Fluid Overload Sodium Chloride Injection USP 0.9% may cause fluid overload in patients with congestive heart failure, severe renal insufficiency, and in clinical states with edema, sodium retention, or hypernatremia. Consider each patient’s age, body weight, fluid status, concomitant medical conditions and planned radiological procedure to determine if use of Sodium Chloride Injection USP 0.9% is appropriate.

5.4Extravasation Extravasation of the Sodium Chloride Injection USP 0.9% may cause mechanical compression of neurovascular structures. Extravasation of contrast agent may result in tissue injury by osmolar and direct cytotoxicity (see package inserts of specific contrast agents). Establish intravascular catheter patency prior to the administration of Sodium Chloride Injection USP 0.9%.

🤒 Adverse Reactions 108 words ▾

6 ADVERSE REACTIONS Reported adverse reactions include: air embolization with stroke, chest pain, and dyspnea arrhythmia hypotension myocardial infarction sepsis febrile response local tenderness infection at the site of injection venous thrombosis or phlebitis extending from injection site extravasation fluid overload hypervolemia Adverse reactions due to solution or administration technique may include: air embolism with stroke, chest pain, and dyspnea, arrhythmia, hypotension, myocardial infarction, sepsis, febrile response, local tenderness, infection at the site of injection, venous thrombosis or phlebitis extending from injection site, extravasation, fluid overload and hypervolemia.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Liebel-Flarsheim Company LLC at 1-855-266-5037 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: It is not known whether Sodium Chloride Injection USP 0.9% can cause fetal harm. ( 8.1 ) Pediatrics: Safety and effectiveness have not been established in pediatric patients. ( 8.4 ) Geriatrics: Dosing for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. ( 8.5 )

8.1Pregnancy Risk Summary Administration of Sodium Chloride Injection USP 0.9% is not known to cause major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with Sodium Chloride Injection USP 0.9.% All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

8.2Lactation Risk Summary Appropriate administration of Sodium Chloride Injection USP 0.9% is not known to cause harm to a breastfed infant.

8.4Pediatric Use Safety and effectiveness of Sodium Chloride Injection USP 0.9% administered by power injection in pediatric patients have not been established. Administration of Sodium Chloride Injection USP 0.9% to pediatric patients by power injection is not recommended. When performing manual injection of Sodium Chloride Injection USP 0.9% to pediatric patients, take into account the patient’s weight, fluid status, and concomitant medical conditions to determine if use of Sodium Chloride Injection USP 0.9% is appropriate.

The safety of manual injection of Sodium Chloride Injection USP 0.9% in pediatric patients is supported by reported clinical experience with intravenous infusion and flush of sodium chloride injection in pediatric patients. To minimize the risk of fluid overload, use the smallest dose of Sodium Chloride Injection USP 0.9% necessary for manually flushing contrast agent through the vascular access line.

8.5Geriatric Use No clinical studies of Sodium Chloride Injection USP 0.9% were conducted. Other reported clinical experience with sodium chloride injection 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.

🤰 Pregnancy 77 words ▾

8.1Pregnancy Risk Summary Administration of Sodium Chloride Injection USP 0.9% is not known to cause major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with Sodium Chloride Injection USP 0.9.% All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

🧒 Pediatric Use 136 words ▾

8.4Pediatric Use Safety and effectiveness of Sodium Chloride Injection USP 0.9% administered by power injection in pediatric patients have not been established. Administration of Sodium Chloride Injection USP 0.9% to pediatric patients by power injection is not recommended. When performing manual injection of Sodium Chloride Injection USP 0.9% to pediatric patients, take into account the patient’s weight, fluid status, and concomitant medical conditions to determine if use of Sodium Chloride Injection USP 0.9% is appropriate.

The safety of manual injection of Sodium Chloride Injection USP 0.9% in pediatric patients is supported by reported clinical experience with intravenous infusion and flush of sodium chloride injection in pediatric patients. To minimize the risk of fluid overload, use the smallest dose of Sodium Chloride Injection USP 0.9% necessary for manually flushing contrast agent through the vascular access line.

🧓 Geriatric Use 74 words ▾

8.5Geriatric Use No clinical studies of Sodium Chloride Injection USP 0.9% were conducted. Other reported clinical experience with sodium chloride injection 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.

🆘 Overdosage 50 words ▾

10 OVERDOSAGE Use of Sodium Chloride Injection USP 0.9% may pose a threat of overdose marked by electrolyte disturbance and/or fluid overload, particularly in pediatric patients and patients with compromised renal or cardiac function. In the event of overdosage, discontinue the infusion, reevaluate the patient and institute appropriate corrective action.

🧬 Clinical Pharmacology 15 words ▾

12 CLINICAL PHARMACOLOGY Sodium Chloride Injection USP 0.9% has an osmotic pressure similar to plasma.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Sodium Chloride Injection USP 0.9% is a clear, colorless, odorless solution containing 9 mg/mL of sodium chloride. Sodium Chloride Injection USP 0.9% is supplied in 125 mL prefilled syringes containing 125 mL of solution. Each syringe is sealed with rubber closures and the contents are sterile.

The 125 mL syringe is supplied with a luer locknut adapter which is cleared for manufacture and distribution as a device under 510(K) number 862653. The syringes are contained in shipping cartons with the following configurations: Volume Packaging NDC 125 mL in plastic syringes 20 syringes per carton 0019-1188-81 125 mL in plastic RFID-Tagged Syringes* 20 syringes per carton 0019-1188-27 *Radio Frequency Identification (RFID) Technology RFID-Tagged Syringe Description This information is for Ultraject ® syringes containing Sodium Chloride Injection USP 0.9% that has been labeled with a Radio Frequency Identification (RFID) tag.

When used with an RFID-enabled Optivantage Injector, this tag allows for the exchange of product information such as lot number, expiration, concentration, and identification of the syringe as being unused prior to use and used after product administration. Patient information is not utilized in any form with this RFID technology. Sodium Chloride Injection USP 0.9% product quality is not impacted with the use of this RFID tag.

Sodium Chloride Injection USP 0.9% RFID syringes require no special handling and should be stored at the conditions listed for the drug product. RFID-Tagged Syringe Directions for Use For the RFID technology to function, the syringe must be used with an Optivantage Injector with RFID technology. Function of the RFID technology is not dependent on syringe orientation as it is placed in the injector.

Instructions for use of the injector are provided on the injector interface screens and operator’s manual. If the RFID tag is damaged or otherwise non-functional, the injector will notify the user. Should this occur, the Sodium Chloride Injection USP 0.9% syringe with the non-functional RFID tag may still be used but no data will be transferred to the injector.

Regarding interference with medical devices, the RFID tag and injector system meet the IEC 60601-1-2 requirements for emission and immunity standards for medical devices. Follow all manufacturers’ guidelines and do not operate any part of the Optivantage Injector System and RFID-tagged syringes within 6 inches (15 cm) of a pacemaker and/or defibrillator. Storage Store Sodium Chloride Injection USP 0.9% syringes and RFID-tagged syringes at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

PROTECT FROM FREEZING Manufactured by: Liebel-Flarsheim Company LLC Raleigh, NC 27616 Made in USA GBT 11880919 Issued: 9/19 Guerbet

📋 Description 106 words ▾

11 DESCRIPTION Sodium Chloride Injection USP 0.9% is a formulation of sodium chloride in Water for Intravascular Injection. No preservative, antimicrobial agent or buffer is added. Sodium Chloride Injection USP 0.9% is provided as a sterile, nonpyrogenic, clear, colorless, odorless solution. Molecular formula = NaCl MW =

58.44Each mL of Sodium Chloride Injection USP 0.9% contains 9 mg of sodium chloride. The pH is 4.5 to 7.0. The osmolarity is 308 mOsm/L (calc.). Sodium Chloride Injection USP 0.9% is provided in a 125 mL syringe with a 125 mL fill. The syringes are for single patient use and are disposable and not meant for reuse.

Glossary — plain-language definitions of medical terms used in this label:

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

arrhythmia: A heartbeat that is too fast, too slow, or irregular instead of steady.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

displacement: When one medicine knocks another off the blood proteins it was riding on, briefly raising the free, active amount of the second medicine.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

edema: Swelling caused by extra fluid trapped in the body's tissues.

electrolyte: A mineral in the blood and body fluids, such as sodium, potassium, or calcium, that carries a small electric charge and helps the body work.

embolism: A blockage of a blood vessel by a clot or other material that has traveled from elsewhere in the body.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

extravasation: The accidental leaking of an injected medicine out of the vein into the surrounding tissue, which can cause pain, swelling, or tissue damage.

febrile: Having a fever, or relating to a fever.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypernatremia: A higher-than-normal level of sodium (salt) in the blood.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

ischemia: Reduced blood flow to a part of the body, so that area does not get enough oxygen.

lactation: The making and release of milk from a mother's breasts after giving birth.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

package insert: The detailed printed information about a medicine, written for health professionals, that comes with the product.

sepsis: A serious, body-wide reaction to an infection in which the body's own response can start to injure its tissues and organs.

thrombosis: The forming of a blood clot inside a blood vessel, which can block normal blood flow.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

🔗 Related NDC lookups

🧪 All Sodium Chloride NDCsSame ingredient 🏭 All Liebel-Flarsheim labeler NDCsLabeler code 00019 📚 All Osmotic Laxative NDCsDrug class 🧾 A4217 billing & NDC crosswalkJ-code 📖 Read the Sodium Chloride drug informationUses, warnings & side effects

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Sodium/Saline Preparations.

0.9 % Sodium Chloride 00264-1800-31 Sodium Chloride 0.45 % 00264-5804-00 Sodium Chloride 3 % 00264-7805-10 Sodium Chloride 5 % 00264-7806-10 Sodium Chloride 00409-1141-02 Bacteriostatic Sodium Chloride 00409-1966-05

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.