Sodium Chloride
General Injectables And Vaccines, Inc.
Human Prescription Drug
NDC 52584-109Sodium Chloride is a human prescription drug labeled by 'General Injectables And Vaccines, Inc.'. National Drug Code (NDC) number for Sodium Chloride is 52584-109. This drug is available in dosage form of Injection, Solution, Concentrate. The names of the active, medicinal ingredients in Sodium Chloride drug includes Sodium Chloride - 4 meq/mL . The currest status of Sodium Chloride drug is Active.
Drug Information:
| Drug NDC: | 52584-109 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Sodium Chloride |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Sodium Chloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | General Injectables And Vaccines, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Solution, Concentrate |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | SODIUM CHLORIDE - 4 meq/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 28 Jul, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Mar, 2024 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA212248 |
| 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. |
| Listing Expiration Date: | 28 Dec, 2025 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | General Injectables and Vaccines, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1807571
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| UNII: | 451W47IQ8X
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 52584-109-01 | 1 VIAL in 1 BAG (52584-109-01) / 30 mL in 1 VIAL | 28 Jul, 2021 | 31 Mar, 2024 | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Sodium chloride sodium chloride sodium chloride chloride ion hydrochloric acid water sodium hydroxide
Indications and Usage:
Indications and usage sodium chloride injection, usp, 23.4%, is indicated as an additive in parenteral fluid therapy for use in patients who have special problems of sodium electrolyte intake or excretion. it is intended to meet the specific requirements of the patient with unusual fluid and electrolyte needs. after available clinical and laboratory information is considered and correlated, the appropriate number of milliequivalents of sodium chloride required can be withdrawn from sodium chloride injection, usp, 23.4% and diluted for use. sodium chloride injection is indicated for the treatment of sodium, chloride and water deficiencies that commonly occur in many diseases. isotonic sodium chloride injection should be limited to cases in which the chloride loss is greater than the sodium loss, as in vomiting from pyloric obstruction, or in which the loss is about equal, as in vomiting from duodenal, jejunal or ileal obstruction and in the replacement of aspirated gastrointestinal flui
Read more...ds. the toxic symptoms that follow various forms of intestinal obstruction are accompanied by a marked reduction of blood chloride and often sodium chloride has a lifesaving effect. symptoms of sodium chloride deficiency are very similar to those of addisonâs disease and large doses of sodium chloride will produce temporary alleviation of the symptoms. other disorders in which sodium chloride is therapeutically useful include extensive burns, failure of gastric secretion and postoperative intestinal paralysis.
Warnings:
Warnings 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. sodium chloride injection, usp, 23.4% 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 and cortical necrosis
Read more...of the kidneys.
Dosage and Administration:
Dosage and administration the dosage of sodium chloride injection, usp, 23.4%, as an additive in parenteral fluid therapy is predicated on specific requirements of the patient after necessary clinical and laboratory information is considered and correlated. the appropriate volume is then withdrawn for proper dilution. having determined the milliequivalents of sodium chloride to be added, divide by four to calculate the numbers of milliliters (ml) of sodium chloride to be used. withdraw this volume aseptically and transfer the additive solution into appropriate intravenous solutions such as 5% dextrose injection. the properly diluted solutions may be given intravenously. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Contraindications:
Contraindications surgical patients should seldom receive salt- containing solutions immediately following surgery unless factors producing salt depletion are present. because of renal retention of salt during surgery, additional electrolyte given intravenously may result in fluid retention, edema and overloading of the circulation.
Adverse Reactions:
Adverse reactions parenteral administration of quantities of sodium in excess of the amount of water or sodium chloride needed or at a rate more rapid than can be accommodated by the patientâs circulatory function may result in edema and clinical findings resembling those of congestive heart failure. adverse effects are particularly likely to develop in patients with impaired renal or cardiac function. signs of postoperative salt intolerance include cellular dehydration, weakness, disorientation, anorexia, nausea, distention, deep respiration, oliguria and increased blood urea nitrogen.
Overdosage:
Overdosage administration of too much sodium chloride may result in serious electrolyte disturbances with resulting retention of water, edema, loss of potassium and aggravation of an existing acidosis. when intake of sodium chloride is excessive, excretion of crystalloids is increased in an attempt to maintain normal osmotic pressure. thus there is increased excretion of potassium and of bicarbonate and, consequently, a tendency toward acidosis. there is also a rapid elimination of any foreign salt, such as iodide and bromide, being used for therapy.
Description:
Description sodium chloride injection, usp, 23.4%, is a concentrated, nonisotonic, sterile, nonpyrogenic solution of sodium chloride 234 mg in water for injection. ph adjusted with sodium hydroxide or hydrochloric acid if necessary. sodium chloride is an electrolyte replenisher. it occurs as colorless cubic crystals or white crystalline powder and has a saline taste. sodium chloride is freely soluble in water; it is soluble in glycerin and slightly soluble in alcohol. the empirical formula for sodium chloride is nacl and the molecular weight is 58.44.
Clinical Pharmacology:
Clinical pharmacology sodium chloride comprises over 90% of the inorganic constituents of the blood serum. both its ions are physiologically important. sodium, more than any other ion, determines the osmotic pressure of interstitial fluids and the degree of hydration of tissues. when the intake of the chloride ion is less than is excreted, there is a relative increase in the blood bicarbonate level, producing the condition known as alkalosis. other symptoms of sodium chloride deficiency are nausea, vomiting and increased irritability of muscles, evidenced by cramps and, possibly, convulsions. it is well known that excessive sweating will cause ââheatcramps,ââ i.e., muscle cramps in the abdomen and extremities, which can be completely relieved only by ingestion of a weak salt solution. approximately 25% of the total body sodium is found in the bone. the regulation of salt and water metabolism is governed by different mechanisms; however, changes in the intake, distri
Read more...bution and output of salt are, in health, associated with collateral shifts of water so that electrolyte concentrations are maintained within a narrow range. in the presence of disease affecting the cardiovascular, hepatic or renal system or in certain endocrinologic disorders, changes in the rate of excretion of salt and water will disturb the homeostatic equilibrium. frequently, abnormalities in the metabolism of water or salt may occur as a result of vomiting, diarrhea, gastrointestinal suction and fever. excessive sweating will produce loss of water or salt, but since the electrolyte concentration is hypotonic, loss of water will predominate. the normal salt intake ranges from 5 to 15 grams daily, most of which is excreted by the kidneys. the control of water and salt excretion in urine is very intricate, involving filtration by the glomerulus and reabsorption by the tubules of approximately 99% of the filtered load. the actual quantities excreted depends on the requirements prevailing at the moment. the finer adjustments of the tubular absorptive mechanisms are influenced by osmotic interrelationships between cell water, plasma and urine and by certain steroid hormones influencing electrolyte excretion and the posterior pituitary hormone regulating water excretion. when food intake ceases or salt is withheld, the content of sodium chloride in urine diminishes rapidly so that the body stores are retained. similar renal retention of electrolytes occurs when salt is lost via gastrointestinal secretion through vomiting, etc. in other conditions, such as congestive heart failure, cirrhosis, nephritis or hypersecretion of the adrenal cortical hormones, the kidney fails to eliminate sufficient sodium. this results in retention of both salt and water, producing an excessive accumulation of extracellular fluid, which may be effectively combated by a sharp restriction of salt intake and use of a diuretic. depletion of body salt may be caused in many ways, one of which is too energetic treatment of fluid and sodium retention. besides this, diabetic acidosis, burns, excessive sweating with free drinking of water, repeated paracentesis for removal of ascitic fluid, adrenal cortical hypofunction and certain forms of nephritis, as well as abnormal losses of gastrointestinal secretions, will cause marked salt depletion. with salt loss, there is a reduction of the osmotic pressure of the extracellular fluid; the urine volume may be retained but it is free of sodium chloride.
How Supplied:
How supplied sodium chloride injection, usp, 23.4% is supplied as follows: store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. preservative free. discard unused portion. use only if solution is clear and seal intact. the container closure is not made with natural rubber latex. image2.jpg
Package Label Principal Display Panel:
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