Sodium Chloride
Fresenius Kabi Usa, Llc
Human Prescription Drug
NDC 63323-090Sodium Chloride is a human prescription drug labeled by 'Fresenius Kabi Usa, Llc'. National Drug Code (NDC) number for Sodium Chloride is 63323-090. 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 - 2.5 meq/mL . The currest status of Sodium Chloride drug is Active.
Drug Information:
| Drug NDC: | 63323-090 |
| 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, 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 - 2.5 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 Apr, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 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. |
| Application Number: | ANDA212070 |
| 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: | 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: | 1807578
1807580
|
| 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. |
| UPC: | 0363323090043
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 63323-090-20 | 25 VIAL, PLASTIC in 1 TRAY (63323-090-20) / 20 mL in 1 VIAL, PLASTIC (63323-090-02) | 28 Apr, 2021 | N/A | No |
| 63323-090-40 | 25 VIAL, PLASTIC in 1 TRAY (63323-090-40) / 40 mL in 1 VIAL, PLASTIC (63323-090-04) | 28 Apr, 2021 | 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 hydrochloric acid water
Indications and Usage:
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.
Warnings:
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 e
Read more...dema. 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.
Dosage and Administration:
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 .)
Contraindications:
Contraindications 14.6% sodium chloride injection, usp additive solution is contraindicated in patients with hypernatremia or fluid retention.
Adverse Reactions:
Adverse reactions sodium overload can occur with intravenous infusion of excessive amounts of sodium-containing solutions. (see warnings and precautions .)
Use in Pregnancy:
Pregnancy 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.
Pediatric Use:
Pediatric use the 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.
Geriatric Use:
Geriatric use an 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.
Overdosage:
Overdosage in the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. (see warnings and precautions .)
Description:
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 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:
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 t
Read more...ubular 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.
How Supplied:
How supplied 14.6% sodium chloride injection, usp additive solution is supplied as the following: product code unit of sale strength/concentration each 919020 ndc 63323-090-20 unit of 25 50 meq/20 ml (2.5 meq/ml) ndc 63323-090-02 20 ml fill in a 20 ml single-dose plastic fliptop vial 919040 ndc 63323-090-40 unit of 25 100 meq/40 ml (2.5 meq/ml) ndc 63323-090-04 40 ml fill in a 50 ml single-dose plastic fliptop vial store at 20° to 25°c (68° to 77°f). [see usp controlled room temperature.] preservative free the container closure is not made with natural rubber latex.
Package Label Principal Display Panel:
Package label - principal display â 14.6% sodium chloride injection, usp vial label ndc 63323-090-02 919020 rx only 14.6% sodium chloride injection, usp 50 meq/20 ml (2.5 meq/ml) concentrate caution: must be diluted for i.v. use 20 ml single dose vial package label - principal display â 14.6% sodium chloride injection, usp vial label
Package label - principal display â 14.6% sodium chloride injection, usp tray label ndc 63323-090-20 919020 14.6% sodium chloride injection, usp 50 meq/20 ml (2.5 meq/ml) concentrate caution: must be diluted for i.v. use rx only 25 x 20 ml single dose vials package label - principal display â 14.6% sodium chloride injection, usp tray label
Package label - principal display â 14.6% sodium chloride injection, usp vial label ndc 63323-090-04 919040 14.6% sodium chloride injection, usp 100 meq/40 ml (2.5 meq/ml) concentrate caution: must be diluted for i.v. use rx only 40 ml single dose vial package label - principal display â 14.6% sodium chloride injection, usp vial label
Package label - principal display â 14.6% sodium chloride injection, usp tray label ndc 63323-090-40 919040 14.6% sodium chloride injection, usp 100 meq/40 ml (2.5 meq/ml) concentrate caution: must be diluted for i.v. use rx only 25 x 40 ml single dose vials package label - principal display â 14.6% sodium chloride injection, usp tray label