NDC 63323-139 Sodium Chloride

Sodium Chloride

NDC Product Information

Sodium Chloride with NDC 63323-139 is a a human prescription drug product labeled by Fresenius Kabi Usa, Llc. The generic name of Sodium Chloride is sodium chloride. The product's dosage form is injection, solution and is administered via intravenous form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1807580.

Dosage Form: Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.

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.

  • HYDROCHLORIC ACID (UNII: QTT17582CB)

Administration Route(s)

What are the Administration Route(s)?
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)

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: Fresenius Kabi Usa, Llc
Labeler Code: 63323
Marketing Category: UNAPPROVED DRUG OTHER - 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: 09-06-2000 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".

* Please review the disclaimer below.

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

Description

Sodium Chloride Injection, USP is a sterile, nonpyrogenic, concentrated solution for intravenous administration ONLY AFTER DILUTION to replenish electrolytes.  The preparation contains 2.5 mEq/mL (14.6%) sodium chloride, in Water for Injection.  The solution contains no bacteriostat, antimicrobial agent or added buffer; pH of the solution ranges from 4.5 to 7.0.  Each mL contains: Sodium chloride 146 mg; Water for Injection q.s. pH may have been adjusted with hydrochloric acid.  The osmolar concentration of the 2.5 mEq/mL solution is 5 mOsmol/mL.  Sodium chloride is chemically designated NaCI, a white crystalline compound freely soluble in water.

Clinical Pharmacology

Sodium chloride in water dissociates to provide sodium (Na+) and chloride (CI—) 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/L.  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 reestablish normal serum sodium concentration.Chloride (CI—) 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 (CI—) are largely under the control of the kidney which maintains a balance between intake and output.

Indications And Usage

Sodium Chloride Injection, USP 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.  Sodium chloride injection may also be added to compatible carbohydrate solutions such as dextrose in water to provide electrolytes.

Contraindications

Sodium chloride injection is contraindicated in patients with hypernatremia or fluid retention.

Warnings

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.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 overloading 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.

Precautions

Do not use unless the solution is clear and seal is intact.  Discard unused portion.Sodium chloride injection 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.

Pregnancy

Teratogenic Effects: Pregnancy Category C—Animal 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.

Adverse Reactions

None known.

Overdosage

In the event of over hydration or solute overload, reevaluate the patient and institute appropriate corrective measures. (See WARNINGS and PRECAUTIONS.)

Dosage And Administration

Sodium chloride injection 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

Sodium Chloride Injection, USP is available in flip-top glass vials. Product  No.NDCNo.%NaClNa+mEq/mLCl -mEq/mLmOsmol/mLFill Volume mL1392063323-139-20   14.6      2.5             2.55201394063323-139-4014.62.52.5540These vials are Single Dose Vials; packaged 25 vials per tray.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].  Do not permit to freeze.

* Please review the disclaimer below.