NDC 79672-613-40 (billing 79672-0613-40) — Sodium Chloride 9 g/1000mL

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 79672-613-40

Product NDC 79672-613

11-digit billing NDC 79672061340

NCPDP billing unit ML — per mL (volume)

RxCUI 1807631, 1807632, 1807633, 1807634, 1807639

UNII 451W47IQ8X

Application # ANDA207956

SPL Set ID 28f79c75-82d2-4912-81fc-a723b5ccf4c1

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2017-05-25

Route INTRAVENOUS

Dosage form INJECTION, SOLUTION

Substance SODIUM CHLORIDE

TE code (Orange Book) AP · RLD · RS

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

GPI-14 79750010002021

GPI class Sodium Chloride

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

Quick answers

GSN (GCN sequence number): 001210
GCN: 02962
GPI-14 (Medi-Span): 79750010002021
HICL (First Databank): 008255
AHFS class code: 40:12.00.00
RxCUI (RxNorm): 1807631

Why two NDCs? The FDA registers this code as 79672-613-40 — 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 → 79672-0613-40. 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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 1, 2026
RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
Medi-Span GPI (licensed)
First Databank (licensed) · refreshed Oct 1, 2026

RxNorm drug class

This medicine belongs to the Sodium class.

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.

RxClass (NLM) · catalog refreshed Oct 1, 2026

Clinical

Label name SODIUM CHLORIDE 0.9% SOLUTION Ingredient 0.9 % Sodium Chloride

📗 Our plain-language guide HelloPharmacist

It depends on the product. IV forms replace fluid and salt, while injection diluents dissolve other drugs. Other forms are used for rinsing, nasal congestion and nasal care, or to...
Follow the directions on your product. Many are used as often as needed by adults and children 4 and over. Do not share the bottle, because that can spread infection.
Some people get fever, irritation or infection at the IV site, or too much fluid in the body. Tell your nurse right away if the IV site hurts or looks red.
What side effects should I expect with IV sodium chloride?

📖 Read our full Sodium Chloride guide →

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.

MedlinePlus (NLM) · refreshed Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 1, 2026

Pricing

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

Price system	Per mL	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026	$0.0121	$121.00 / 10000 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.

CMS NADAC weekly file
CMS ASP pricing files · refreshed Sep 20, 2026
CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 2026
CMS Part D plan pricing files · refreshed Sep 24, 2026
VA National Acquisition Center price file

Billing & reimbursement

FDA NDC (as labeled)79672-613-40

11-digit billing NDC79672-0613-40

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

How the units are derivedThis package is 500 ML; the HCPCS unit is 500 ML, so one package = 0 billing units.

Medicare Part B spend (2026 (Q1))$60,184 · 40,325 claims · $1.49 per claim (all NDCs under J7040)

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.

CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
DMEPDAC NDC-HCPCS crosswalk
openFDA NSDE billing units · refreshed Sep 7, 2026

Packaging — all sizes for this product

Package NDC	Description	Marketing start	Marketing end	Status
79672-0613-10 79672-613-10 Main listing	115 BAG in 1 CARTON / 50 mL in 1 BAG	2021-02-15	—	Active
79672-0613-20 79672-613-20	70 BAG in 1 CARTON / 100 mL in 1 BAG	2021-02-15	—	Active
79672-0613-30 79672-613-30	28 BAG in 1 CARTON / 250 mL in 1 BAG	2021-02-15	—	Active
79672-0613-40 You're viewing this	20 BAG in 1 CARTON / 500 mL in 1 BAG	2021-02-15	—	Active
79672-0613-50 79672-613-50	10 BAG in 1 CARTON / 1000 mL in 1 BAG	2021-02-15	—	Active

Pack size FAQ

What quantity is in this package?

This package is listed by the FDA — 20 bag in 1 carton / 500 ml in 1 bag.

What NDC number is used to bill for this package of Sodium Chloride 9 g/1000mL Injection, Solution?

Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Sodium Chloride 9 g/1000mL 84549-0049-48	ProPharma	100 ml	—	—	FDA listed	—
Sodium Chloride 9 g/1000mL 00338-9810-24	Baxter	500 ml	—	—	FDA listed	—
Sodium Chloride 9 g/1000mL 00338-0049-01	Baxter	150 ml	—	—	Discontinued	—
Sodium Chloride 9 g/1000mL 00338-9663-60	Baxter	100 ml	—	—	FDA listed	—
Sodium Chloride 9 g/1000mLthis 79672-0613-40	Nextgen	500 ml	—	AP	FDA listed	—
Sodium Chloride 9 g/1000mL 00338-9808-24	Baxter	500 ml	—	—	FDA listed	—
Sodium Chloride 9 g/1000mL 81826-0001-01	CODAN	50 ml	—	AP	FDA listed	—
Sodium Chloride 9 g/1000mL 00338-9543-01	Baxter	250 ml	—	—	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 85766-0059-00	Sportpharm	1000 ml	—	—	FDA listed	—
Sodium Chloride 9 g/1000mL 00338-9657-75	Baxter	50 ml	—	—	FDA listed	—
Sodium Chloride 9 g/1000mL 00338-9661-60	Baxter	100 ml	—	—	FDA listed	—
Sodium Chloride 9 g/1000mL 00338-9791-40	Baxter	250 ml	—	—	FDA listed	—
Sodium Chloride 9 g/1000mL 00338-9659-75	Baxter	50 ml	—	—	FDA listed	—
Sodium Chloride 9 g/1000mL 00338-9793-12	Baxter	1000 ml	—	—	FDA listed	—
Sodium Chloride 9 g/1000mL 00338-9804-40	Baxter	250 ml	—	—	FDA listed	—
Sodium Chloride 9 g/1000mL 00338-9806-12	Baxter	1000 ml	—	—	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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA Orange Book · refreshed Sep 3, 2026
CMS NADAC weekly file

Availability & generic status

🏛️

2017

On the market since

May 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.

FDA Orange Book · refreshed Sep 3, 2026

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 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.

FDA label on DailyMed · label index refreshed Oct 1, 2026
FDA openFDA NDC Directory · synced Oct 1, 2026

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerNextgen Pharmaceuticals LLC

Application holderLABORATORIOS GRIFOLS SA

FDA applicationANDA207956 (ANDA)

Labeler code79672

First marketedMay 2017

Product typeHuman Prescription Drug

🔎 All NDCs from Nextgen Pharmaceuticals 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.

FDA openFDA NDC Directory · synced Oct 1, 2026
Drugs@FDA

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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📖 Instructions for Use 📄 Package Label / Principal Display Panel

🎯 Indications and Usage 33 words ▾

INDICATIONS AND USAGE Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. 0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION Important Preparation and Administration Instructions Sodium Chloride Injection, USP is intended for intravenous administration using sterile equipment. 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. To reduce the risk of air embolism, adhere to the following preparation instructions for Sodium Chloride Injection, USP: Use a non-vented infusion set or close the vent on a vented set. Use a dedicated line without any connections (do not connect flexible containers in series).

The use of pressure infusion is not recommended as a method to increase flow rates. However, if pressure infusion is required, ensure that any air within the bag is fully evacuated prior to initiation of infusion. If using a pumping device to administer Sodium Chloride Injection, turn off the pump before the container is empty.

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 disturbances 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, monitor fluid balance, electrolyte concentrations, and acid base balance, as needed and especially during prolonged use.

Hyponatremia 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, 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 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 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.

🤒 Adverse Reactions 144 words ▾

ADVERSE REACTIONS Post-Marketing Adverse Reactions The following adverse reactions have been identified during post approval use of 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: General disorders and administration site conditions: Infusion site erythema, injection site streaking, burning sensation, and infusion site urticaria.

Hypersensitivity reactions: Hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus. Metabolism and nutrition disorders: Hypernatremia, hyponatremia, hyperchloremic metabolic acidosis. 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.

🆘 Overdosage 106 words ▾

OVERDOSAGE Excessive administration of 0.9% Sodium Chloride Injection, USP can cause hypernatremia. Hypernatremia can lead to CNS manifestations, including seizures, coma, cerebral edema and death. Excessive administration of 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 176 words ▾

HOW SUPPLIED The available sizes of 0.9% Sodium Chloride Injection, USP are shown below: Size (mL) NDC Fleboflex bags: 50 (115 units in one carton) 79672-613-10 100 (70 units in one carton) 79672-613-20 250 (28 units in one carton) 79672-613-30 500 (20 units in one carton) 79672-613-40 1000 (10 units in one carton) 79672-613-50 Fleboflex Luer bags : 50 (90 units in one carton) Not distributed by Nextgen Pharmaceuticals LLC 100 (50 units in one carton) Not distributed by Nextgen Pharmaceuticals LLC 250 (32 units in one carton) Not distributed by Nextgen Pharmaceuticals LLC 500 (24 units in one carton) Not distributed by Nextgen Pharmaceuticals LLC 1000 (10 units in one carton) Not distributed by Nextgen Pharmaceuticals LLC Exposure of pharmaceutical products to heat should be minimized.

Avoid excessive heat. It is recommended the product be stored at 20° to 25°C (68° to 77°F); excursions are permitted between 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature.]Store unit in moisture barrier overwrap. Brief exposure up to 40°C (104°F) does not adversely affect the product.

📋 Description 156 words ▾

DESCRIPTION Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The pH ranges from 4.5 to 7.0.

Composition, osmolarity, and ionic concentration are shown below: 0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride. The FLEBOFLEX and FLEBOFLEX LUER plastic containers are fabricated from latex-free polyolefins or polypropylene plastic materials.

The solution contact materials do not contain PVC, DEHP, or other plasticizers. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. The suitability of the container materials has been established through biological evaluations, which have shown the containers pass Class VI U.S.

Pharmacopeia (USP) testing for plastic containers. These tests confirm the biological safety of the container systems.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS Patients with Severe Renal Impairment Administration of Sodium Chloride Injection, USP in patients with or at risk of severe renal impairment, may result in hypernatremia and/or fluid overload (see Warnings ). Avoid Sodium Chloride Injection, USP in patients with severe renal impairment or conditions that may cause sodium and/or potassium retention, fluid overload, or edema. If use cannot be avoided, monitor patients with severe renal impairment for development of these adverse reactions.

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 increased during administration of 0.9% Sodium Chloride Injection, USP. Monitor serum lithium concentrations during concomitant use. Other Drugs that Increase the Risk of Hyponatremia Administration of Sodium Chloride Injection, USP in patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia.

Avoid use of 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 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.

Lactation It is not known whether this drug is present in human milk. Because many drugs are present in human milk, caution should be exercised when Sodium Chloride Injection, USP is administered to a nursing woman. 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 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.

📖 Instructions for Use ~1 min read ▾

DIRECTIONS FOR USE OF FLEBOFLEX AND FLEBOFLEX LUER PLASTIC CONTAINERS For Information on Risk of Air Embolism – see Dosage and Administration. To Open Peel off the overwrap and remove solution container. Visually inspect the container.

If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety.

The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired.

If supplemental medication is desired, follow directions below. Preparation for Administration 1.Suspend container from eyelet support. 2.

Fleboflex bags: Remove plastic protector from outlet port at bottom of container. Fleboflex Luer bags: Break the twist-off administration port by means of torsion. 3.

Attach administration set. Refer to complete directions accompanying set. To Add Medication Additives may be incompatible.

To add medication before solution administration 1. Prepare medication site. 2.

Fleboflex bags: Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject. Fleboflex Luer bags: Using syringe or vial, connect to the needle-free medication port and inject. 3.

Mix solution and medication thoroughly. To add medication during solution administration 1. Close clamp on the set.

2. Prepare medication site. 3.

Fleboflex bags: Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject. Fleboflex Luer bags: Using syringe or vial, connect to the needle-free medication port and inject. 4.

Remove container from intravenous pole and/or turn to an upright position. 5. Mix solution and medication thoroughly.

6. Return container to in-use position and continue administration. Distributed by: Nextgen Pharmaceuticals LLC Brooklyn, NY 11207 Manufactured by: Laboratorios Grifols, S.A.

30565 Murcia - SPAIN Printed in SPAIN Rev. 04/2025 GRIFOLS and FLEBOFLEX are trademarks of Grifols, S.A. NEXTGEN PHARMACEUTICALS (Internal reference)

📄 Package Label / Principal Display Panel ~1 min read ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 79672-613-40 0.9% Sodium Chloride Injection, USP 500 mL Fleboflex Container Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [see USP controlled Room Temperature.] Avoid excessive heat. NEXTGEN PHARMACEUTICALS Manufactured for Nextgen Pharmaceuticals LLC Brooklyn, NY 11207 Product of Spain LOT XXXXXX EXP YYYY-MM 1002054 Num.: IN HOUSE CONTROL NUMBER 20 x 500 mL NDC 79672-613-04 0.9% Sodium Chloride Injection, USP 500 mL For Intravenous use Single dose container Rx Only Each 100 mL contains 900 mg Sodium Chloride USP; pH 4.5 to

7.0Sodium 154 mEq/L Chloride 154 mEq/L; Osmolarity 308 mOsmol/L (calc) Sterile Non pyrogenic. Dosage intravenously as directed by a physician. See directions.

Cautions: Squeeze and inspect inner bag which maintains product sterility. Discard if leaks are found. Must not be used in series connections.

Do not use unless solution is clear. Additives may be incompatible. Consult with pharmacist if available.

When introducing additives, use aseptic technique. Mix thoroughly. Do not store.

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature.] Store unit in moisture barrier overwrap. Brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat.

Read package insert for full information. Grifols and Fleboflex are trademarks of Grifols, S.A. Manufactured for Nextgen Pharmaceuticals LLC Brooklyn, NY 11207 Product of Spain Fleboflex Container (PVC-free and DEHP-free) The container closure is not made with natural rubber latex.

NEXTGEN PHARMACEUTICALS LOT XXXXXX EXP YYYY-MM INTERNAL REFERENCE 4000793

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

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

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.

cirrhosis: Long-term scarring of the liver that gradually replaces healthy tissue and reduces how well the liver works.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

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

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

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

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

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.

encephalopathy: Any condition that affects how the brain works, causing confusion, memory problems, or changes in alertness.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

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.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

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

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hyponatremia: A lower-than-normal level of sodium (salt) in the blood.

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

hypoxemia: A lower-than-normal level of oxygen in the blood.

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.

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

lethargy: A state of tiredness and sluggishness, often with slowed thinking or movement.

metabolic acidosis: A condition where too much acid builds up in the body's blood and fluids.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

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.

peripheral edema: Swelling, usually in the feet, ankles, or legs, caused by extra fluid building up in the tissues.

pruritus: Itching of the skin.

pyrexia: A raised body temperature; a fever.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

Rx only: A label marking meaning the medicine can be obtained only with a prescription from a licensed health professional.

SIADH: Syndrome of inappropriate antidiuretic hormone: the body makes too much of a water-holding hormone, which lowers the level of sodium (salt) in the blood.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

urticaria: Raised, itchy welts on the skin, commonly called hives.

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

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

Medicare Part D (outpatient prescription) spending for Sodium Chloride — the program that covers self-administered drugs. 9 manufacturers.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Sodium Chloride. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$2.42M

Claims incl. refills

105K

Beneficiaries

50.3K

Spend / beneficiary

$48.15

Spend / claim

$23.08

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	✓ Available
Medicaid utilization (CMS SDUD)	— 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Nextgen Pharmaceuticals 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 4 other package presentations of this same product, including 50 ml (79672-0613-10), 100 ml (79672-0613-20), 250 ml (79672-0613-30). 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?

Nextgen Pharmaceuticals 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.

Related NDC lookups

🧪 All Sodium Chloride NDCsSame ingredient 🏭 All Nextgen labeler NDCsLabeler code 79672 🧾 J7040 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.

Sodium Chloride 0.9 % (Flush) 00019-1188-27 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.

First Databank (licensed) · refreshed Oct 1, 2026

Sodium Chloride 9 g/1000mL Injection, Solution — NDC 79672-613-40 (Billing 79672-0613-40)

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

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

RxNorm drug class

Clinical

Patient education

Supplement & herbal interactions

Pricing

Billing & reimbursement

Packaging — all sizes for this product

Pack size FAQ

Therapeutic equivalents

Availability & generic status

Inactive Ingredients / Excipients

Inactive ingredient FAQ

Manufacturer & labeler

Full prescribing information FDA SPL

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

About this NDC listing & data coverage

Questions about this listing

Related NDC lookups

Related drugs in this class