Sodium Chloride 9 g/1000mL Injection, Solution — NDC 76297-001-01 (Billing 76297-0001-01)
This is a package of Sodium Chloride 9 g/1000mL Injection, Solution from LABORATORIOS GRIFOLS SA, marketed since May 2017 and currently FDA-listed. It is the main listing for this product, which comes in 10 package sizes.
Other active recalls for Sodium Chloride (different manufacturers) — 6 · tap to view
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
- GSN (GCN sequence number): 001210
- GCN: 02962
- HICL (First Databank): 008255
- AHFS class code: 40:12.00.00
- RxCUI (RxNorm): 1807631
Where does this data come from?
- 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.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- 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?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Sodium Chloride — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Billing & reimbursement
Where does this data come from?
- 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 |
|---|---|---|---|---|
| 76297-0001-01 You're viewing this Main listing | 20 BAG in 1 CARTON / 500 mL in 1 BAG | 2017-05-25 | — | Active |
| 76297-0001-11 76297-001-11 | 115 BAG in 1 CARTON / 50 mL in 1 BAG | 2018-12-01 | — | Active |
| 76297-0001-21 76297-001-21 | 70 BAG in 1 CARTON / 100 mL in 1 BAG | 2018-12-01 | — | Active |
| 76297-0001-31 76297-001-31 | 28 BAG in 1 CARTON / 250 mL in 1 BAG | 2018-12-01 | — | Active |
| 76297-0001-41 76297-001-41 | 10 BAG in 1 CARTON / 1000 mL in 1 BAG | 2019-03-01 | — | Active |
| 76297-0001-51 76297-001-51 | 90 BAG in 1 CARTON / 50 mL in 1 BAG | 2022-08-06 | — | Active |
| 76297-0001-61 76297-001-61 | 50 BAG in 1 CARTON / 100 mL in 1 BAG | 2022-08-06 | — | Active |
| 76297-0001-71 76297-001-71 | 32 BAG in 1 CARTON / 250 mL in 1 BAG | 2022-08-06 | — | Active |
| 76297-0001-81 76297-001-81 | 24 BAG in 1 CARTON / 500 mL in 1 BAG | 2022-08-06 | — | Active |
| 76297-0001-91 76297-001-91 | 10 BAG in 1 CARTON / 1000 mL in 1 BAG | 2026-05-31 | — | Active |
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Sodium Chloride 9 g/1000mL Injection, Solution?
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/1000mL 79672-0613-10 | Nextgen | 50 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/1000mLthis 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 | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
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?
- 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?
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?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 ▾
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 ▾
CONTRAINDICATIONS None known.
⚠️ Warnings ▾
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 ▾
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.
Hypersensitvity 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 ▾
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 ▾
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 ▾
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) 76297-001-11 100 (70 units in one carton) 76297-001-21 250 (28 units in one carton) 76297-001-31 500 (20 units in one carton) 76297-001-01 1000 (10 units in one carton) 76297-001-41 Fleboflex Luer bags : 50 (90 units in one carton) 76297-001-51 100 (50 units in one carton) 76297-001-61 250 (32 units in one carton) 76297-001-71 500 (24 units in one carton) 76297-001-81 1000 (10 units in one carton) 76297-001-91 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 ▾
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.
Medicare Part D spend CMS · PART D · 2026 (Q1)
About this NDC listing & data coverage
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. |