NDC 0990-6138 Sodium Chloride

Sodium Chloride

NDC Product Code 0990-6138

NDC 0990-6138-03

Package Description: 24 BOTTLE, PLASTIC in 1 CASE > 500 mL in 1 BOTTLE, PLASTIC

NDC 0990-6138-22

Package Description: 24 BOTTLE, PLASTIC in 1 CASE > 250 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Sodium Chloride with NDC 0990-6138 is a a human prescription drug product labeled by Icu Medical Inc.. The generic name of Sodium Chloride is sodium chloride. The product's dosage form is irrigant and is administered via irrigation form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 486515.

Dosage Form: Irrigant - A sterile solution intended to bathe or flush open wounds or body cavities; they're used topically, never parenterally.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Sodium Chloride Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Irrigation - Administration to bathe or flush open wounds or body cavities.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Icu Medical Inc.
Labeler Code: 0990
FDA Application Number: NDA017514 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 08-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Sodium Chloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index


These products are sterile, nonpyrogenic solutions of electrolytes in water for injection intended only for sterile irrigation, washing, rinsing and dilution purposes.Each 100 mL of 0.9% Sodium Chloride Irrigation, USP contains: Sodium chloride 900 mg; pH 5.6 (4.5 to 7.0). May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The solution is isotonic (308 mOsmol/liter, CALC.) and has the following electrolyte content (mEq/liter): Na+ 154; Cl− 154.These irrigations contain no bacteriostat, antimicrobial agent or added buffer and are intended only for use as single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded.Each of these irrigations may be classified as a sterile irrigant, wash, rinse, diluent and pharmaceutical vehicle.Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.Water for Injection, USP is chemically designated H2O.The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The container requires no vapor barrier to maintain the proper drug concentration.Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

Clinical Pharmacology

Each of these irrigation solutions exert a mechanical cleansing action for sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters and surgical drainage tubes and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. Each also serves as a diluent or vehicle for drugs used for irrigation or other pharmaceutical preparations.0.9% Sodium Chloride Irrigation, USP provides an isotonic saline irrigation identical in composition with 0.9% Sodium Chloride Injection, USP (normal saline).0.9% Sodium Chloride Irrigation, USP is considered generally compatible with living tissues and organs.Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl−) ions. Sodium (Na+) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl−) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na+) and chloride (Cl−) are largely under the control of the kidney which maintains a balance between intake and output.Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

Indications And Usage

Each of these solutions is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.


NOT FOR INJECTION BY USUAL PARENTERAL ROUTES.An electrolyte solution should not be used for irrigation during electrosurgical procedures.


FOR IRRIGATION ONLY. NOT FOR INJECTION.Entry of a hypotonic solution into the circulation may cause hemolysis. Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus each of these irrigations must be regarded as a systemic drug. Absorption of large amounts can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.Do not heat container over 66°C (150°F).


Do not use for irrigation that may result in absorption into the blood.Caution should be observed when a hypotonic solution is used for continuous irrigation or allowed to "dwell" inside body cavities because of possible absorption into the blood stream and the production of intravascular hemolysis and circulatory overload.Aseptic technique is essential with the use of sterile solutions for irrigation of body cavities, wounds and urethral catheters or for wetting dressings that come in contact with body tissues.When used as a "pour" irrigation, no part of the contents should be allowed to contact the surface below the outer protected thread area of the semi-rigid wide mouth container. The flexible container is designed for use with nonvented irrigation sets. When used for irrigation via irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start-up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient.Do not administer unless solution is clear, seal is intact and container is undamaged.Discard unused portion.

Carcinogenesis, Mutagenesis, Impairment Of Fertility:

Studies with Sodium Chloride Irrigation, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Nursing Mothers:

Caution should be exercised when Sodium Chloride Irrigation, USP is administered to a nursing woman.


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

Pediatric Use:

Safety and effectiveness of Sodium Chloride irrigation solution in pediatric patients have not been established by adequate and well-controlled trials. However, the use of Sodium Chloride irrigation solution in the pediatric population is referenced in the medical literature. The Warnings, Precautions, and Adverse Reactions identified in the label should be observed in the pediatric population.

Geriatric Use:

An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients.This drug is known to be substantially secreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Adverse Reactions

Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes are usually avoidable when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection.Should any adverse reaction occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.


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

Dosage And Administration

The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a diluent or vehicle for other drugs, the manufacturer's recommendations should be followed.Drug InteractionsAdditives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. See PRECAUTIONS.

How Supplied

0.9% Sodium Chloride Irrigation, USP:Container SizeNDCSingle-dose 500 mL semi-rigid irrigation container0409-6138-03Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USASingle-dose 500 mL semi-rigid irrigation container0990-6138-03Single-dose 250 mL semi-rigid irrigation container0409-6138-22Single-dose 250 mL semi-rigid irrigation container0990-6138-22Single-dose 1000 mL semi-rigid irrigation container0409-7138-09Single-dose 1000 mL semi-rigid irrigation container0990-7138-09Single-dose 1500 mL semi-rigid irrigation container0409-7138-36Single-dose 1500 mL semi-rigid irrigation container0990-7138-36Single-dose 1000 mL flexible irrigation container0409-7972-05Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USASingle-dose 1000 mL flexible irrigation container0990-7972-05Single-dose 2000 mL flexible irrigation container0409-7972-07Single-dose 2000 mL flexible irrigation container0990-7972-07ICU Medical is transitioning NDC codes from "0409" to "0990" labeler code. Both NDC codes are expected to be in the market for a period of time.Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.Revised: July, 2018EN-4660ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

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