NDC 0409-6660 Sodium Chloride

Sodium Chloride

NDC Product Code 0409-6660

NDC Product Information

Sodium Chloride with NDC 0409-6660 is a a human prescription drug product labeled by Hospira, Inc.. The generic name of Sodium Chloride is sodium chloride. The product's dosage form is injection, solution, concentrate and is administered via intravenous form.

Labeler Name: Hospira, Inc.

Dosage Form: Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.

Product Type: Human Prescription Drug Additional informationCallout TooltipWhat 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)

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

  • SODIUM CHLORIDE 5.84 g/40mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • WATER (UNII: 059QF0KO0R)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)

Administration Route(s)

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The translation of the route code submitted by the firm, indicating route of administration.

  • Intravenous - Administration within or into a vein or veins.

Pharmacological Class(es)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Hospira, Inc.
Labeler Code: 0409
FDA Application Number: NDA018897 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 07-29-2005 Additional informationCallout TooltipWhat 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: 12-31-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Values = ‘Y’ or ‘N’.

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Sodium Chloride Product Label Images

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

Other

CONCENTRATE CAUTION: MUST BE DILUTED FOR I.V. USE14.6%Sodium Chloride Injection, USP                                                                                                           Rx only50 mEq/20 mL or 100 mEq/40 mL(2.5 mEq/mL)Additive SolutionConcentrated Solution —For use only after dilution with compatible I.V. fluids to correct sodium deficiency when oral replacement is not feasible.Plastic Vial

Description

14.6% Sodium Chloride Injection, USP Additive Solution is a sterile, nonpyrogenic, concentrated solution for intravenous administration ONLY AFTER DILUTION to replenish electrolytes. The preparations contain either 2.92 or 5.84 g of sodium chloride (50 or 100 mEq each of Na+ and Cl¯) in Water for Injection, USP. The solution contains no bacteriostat, antimicrobial agent or added buffer; pH 4.8 (4.5 to 7.0). May contain hydrochloric acid for pH adjustment. The osmolar concentration is 5 mOsmol/mL (calc.); specific gravity is 1.10.Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water.The semi-rigid material used for the plastic vials is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.

Clinical Pharmacology

Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl¯) ions. These ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance. Sodium is the principal cation of extracellular fluid. It comprises more than 90% of the total cations at its normal plasma concentration of approximately 142 mEq/liter. While the sodium ion can diffuse across cell membranes, intracellular sodium is maintained at a much lower concentration than extracellular sodium through the expenditure of energy by the cell (so called "sodium cation pump"). Loss of intracellular potassium ion is usually accompanied by an increase in intracellular sodium ion.When serum sodium concentration is low, the secretion of antidiuretic hormone (ADH) by the pituitary is inhibited, thereby preventing water reabsorption by the distal renal tubules. On the other hand, adrenal secretion of aldosterone increases renal tubular reabsorption of sodium in an effort to re-establish normal serum sodium concentration.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.

Indications And Usage

14.6% Sodium Chloride Injection, USP Additive Solution is indicated for parenteral restoration of sodium ion in patients with restricted oral intake. Sodium replacement is specifically indicated in patients with hyponatremia or low salt syndrome. 14.6% Sodium Chloride Additive Solution may also be added to compatible carbohydrate solutions such as dextrose in water to provide electrolytes.

Contraindications

14.6% Sodium Chloride Injection, USP Additive Solution is contraindicated in patients with hypernatremia or fluid retention.

Warnings

14.6% Sodium Chloride Injection, USP is hypertonic and must be diluted prior to administration. Inadvertent direct injection or absorption of concentrated sodium chloride solution may give rise to sudden hypernatremia and such complications as cardiovascular shock, central nervous system disorders, extensive hemolysis, cortical necrosis of the kidneys and severe local tissue necrosis (if administered extravascularly).Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention.In patients with diminished renal function, administration of solutions containing sodium may result in sodium retention.The intravenous administration of this solution (after appropriate dilution) can cause fluid and/or solute overload resulting in dilution of other serum electrolyte concentrations, overhydration, congested states or pulmonary edema.Excessive administration of potassium free solutions may result in significant hypokalemia.WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Precautions

14.6% Sodium Chloride Injection, USP Additive Solution must be diluted before infusion to avoid a sudden increase in the level of plasma sodium. Too rapid administration should be avoided.Special caution should be used in administering sodium containing solutions to patients with severe renal impairment, cirrhosis of the liver, cardiac failure, or other edematous or sodium-retaining states.Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin.Do not use unless the solution is clear and seal is intact. Discard unused portion.PregnancyAnimal reproduction studies have not been conducted with sodium chloride. It is also not known whether sodium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium chloride should be given to a pregnant woman only if clearly needed.Geriatric UseAn evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.Pediatric UseThe safety and effectiveness of 14.6% Sodium Chloride Injection, USP Additive Solution have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.

Adverse Reactions

Sodium overload can occur with intravenous infusion of excessive amounts of sodium-containing solutions. (See WARNINGS and PRECAUTIONS.)

Overdosage

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

Dosage And Administration

14.6% Sodium Chloride Injection, USP Additive Solution is administered intravenously only after addition to a larger volume of fluid.The dose, dilution and rate of injection are dependent upon the individual needs of each patient.All or part of the contents of one or more additive containers may be added to an intravenous solution container. Concentrations of up to 5% sodium chloride have been administered.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS.)

How Supplied

14.6% Sodium Chloride Injection, USP Additive Solution is supplied as the following:Unit of SaleConcentrationEachNDC 0409-6657-73Tray of 2550 mEq/20 mL(2.5 mEq/mL)NDC 0409-6657-0120 mL Single-dose Plastic Fliptop VialNDC 0409-6660-75Tray of 25100 mEq/40 mL(2.5 mEq/mL)NDC 0409-6660-0140 mL Single-dose Plastic Fliptop VialStore at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Distributed by Hospira, Inc., Lake Forest, IL 60045 USALAB-1099-1.09/2017

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