Sodium Chloride
Fresenius Kabi Usa, Llc
Human Prescription Drug
NDC 63323-088Sodium Chloride is a human prescription drug labeled by 'Fresenius Kabi Usa, Llc'. National Drug Code (NDC) number for Sodium Chloride is 63323-088. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Sodium Chloride drug includes Sodium Chloride - 234 mg/mL . The currest status of Sodium Chloride drug is Active.
Drug Information:
| Drug NDC: | 63323-088 |
| 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: | Fresenius Kabi Usa, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Solution |
| 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 - 234 mg/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: | UNAPPROVED DRUG OTHER |
| 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: | 12 Jan, 2001 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 17 Dec, 2025 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| 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: | Fresenius Kabi USA, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 313016
|
| 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. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| 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. |
| Pharmacologic Class: | Increased Large Intestinal Motility [PE]
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
Osmotic Activity [MoA]
Osmotic Laxative [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 63323-088-61 | 10 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-088-61) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE | 12 Jan, 2001 | N/A | No |
| 63323-088-63 | 10 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-088-63) / 200 mL in 1 VIAL, PHARMACY BULK PACKAGE | 12 Jan, 2001 | N/A | 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 sodium cation chloride ion
Indications and Usage:
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.
Warnings:
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 ret
Read more...ention. 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.
Dosage and Administration:
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.
Contraindications:
Contraindications sodium chloride injection is contraindicated in patients with hypernatremia or fluid retention.
Adverse Reactions:
Adverse reactions none known.
Overdosage:
Overdosage in the event of overhydration or solute overload, reevaluate the patient and institute appropriate corrective measures. (see warnings and precautions .)
Description:
Description sodium chloride injection, usp is a sterile, nonpyrogenic, concentrated solution for intravenous administration only after dilution to replenish electrolytes. the preparation contains 4 meq/ml (23.4%) 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 234 mg; water for injection q.s. ph may have been adjusted with hydrochloric acid. the osmolar concentration of the 4 meq/ml solution is 8 mosmol/ml (calculated). sodium chloride is chemically designated naci, a white crystalline compound freely soluble in water. a pharmacy bulk package is a sterile dosage form containing many single doses. the contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for iv infusion.
Clinical Pharmacology:
Clinical pharmacology sodium chloride in water dissociates to provide sodium (na + ) and chloride (ci â ) 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 ââsodium cation pumpââ). 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 aldost
Read more...erone increases renal tubular reabsorption of sodium in an effort to reestablish normal serum sodium concentration. chloride (ci â ) 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 â ) are largely under the control of the kidney which maintains a balance between intake and output.
How Supplied:
How supplied sodium chloride injection, usp is available in flip-top glass vials. product no. ndc no. % naci na + meq/ml ci â meq/ml mosmol/ ml fill volume ml 88b1 63323-088-61 23.4 4 4 8 100 88b2 63323-088-63 23.4 4 4 8 200 packaged in 20 and 10 vials per tray, respectively. store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. do not permit to freeze.
Package Label Principal Display Panel:
Package label - principal display - sodium chloride 200 ml vial label ndc 63323-088-63 88b2 sodium chloride injection, usp concentrated pharmacy bulk package - not for direct infusion 23.4% (4 meq/ml) for iv use only after dilution rx only 200 ml 88b2 vial