Sodium Chloride
Hospira, Inc.
Human Prescription Drug
NDC 0409-1141Sodium Chloride is a human prescription drug labeled by 'Hospira, Inc.'. National Drug Code (NDC) number for Sodium Chloride is 0409-1141. 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 - 234 mg/mL . The currest status of Sodium Chloride drug is Active.
Drug Information:
| Drug NDC: | 0409-1141 |
| 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: | Hospira, 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 - 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: | NDA |
| 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: | 30 Apr, 2005 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 30 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: | NDA018897 |
| 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: | Hospira, Inc.
|
| 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 |
|---|
| 0409-1141-02 | 25 VIAL, PHARMACY BULK PACKAGE in 1 CASE (0409-1141-02) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0409-1141-12) | 30 Apr, 2005 | 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 sodium hydroxide hydrochloric acid water
Indications and Usage:
Indications and usage 23.4% sodium chloride injection, usp is indicated for use as an electrolyte replenisher in parenteral fluid therapy. it serves as an additive for total parenteral nutrition (tpn) and as an additive for carbohydrate containing i.v. fluids.
Warnings:
Warnings 23.4% 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, specifically osmotic demyelination syndrome, 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 overloading resulting in dilution of other serum electrolyte concentrations
Read more..., 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.
General Precautions:
General excessive amounts of sodium chloride by any route may cause hypokalemia and acidosis. excessive amounts by the parenteral route may precipitate congestive heart failure and acute pulmonary edema, especially in patients with cardiovascular disease and in patients receiving corticosteroids or corticotropin or drugs that may give rise to sodium retention. special caution should be used in administering sodium-containing solutions to patients with severe renal impairment, cirrhosis of the liver 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. do not use unless the solution is clear and seal is intact.
Dosage and Administration:
Dosage and administration 23.4% 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. in solutions for total parenteral nutrition (tpn), 120 meq of sodium/day (range: 75â180 meq/day) is the recommended adult dosage, whereas the recommended dosage is 3â4 meq/kg/day for preterm infants. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. discard unused portion. additives may be incompatible with the fluid dispensed from this container. consult with pharmacist, if available. when admixing, use aseptic technique, mix thoroughly and do not store. directions for proper use of pharmacy bulk package use aseptic technique for hanger application, peel off the paper liner from both ends of the tape hanger to exp
Read more...ose 3/4 in. long adhesive portions. adhere each end to the label on the bottle. during use, container must be stored and all manipulations performed in an appropriate laminar flow hood. remove cover from container and cleanse closure with antiseptic. insert suitable sterile dispensing set or transfer device and suspend unit in a laminar flow hood. the closure should be entered only once and after initial entry, the withdrawal of container contents should be completed promptly in one continuous operation. should this not be possible, a maximum time of 4 hours from initial closure puncture is permitted to complete fluid transfer operations; i.e., discard container no later than 4 hours after initial closure puncture. sequentially dispense aliquots of 23.4% sodium chloride injection, usp into intravenous containers using appropriate transfer device. during fluid transfer operations, the pharmacy bulk package should be maintained under the storage conditions recommended in the labeling. inspect solution after admixing. discard if the solution is discolored or particulates are observed.
Contraindications:
Contraindications 23.4% 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 23.4% sodium chloride injection, usp. 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 safety and effectiveness of 23.4% sodium chloride injection, usp have not been established in pediatric patients. 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 excessive administration of 23.4% sodium chloride injection, usp may result in electrolyte imbalance with water retention, edema, loss of potassium and aggravation of an existing acidosis. see warnings .
Description:
Description 23.4% sodium chloride injection, usp additive solution is a sterile, nonpyrogenic, concentrated solution for intravenous administration only after dilution to replenish electrolytes. the preparations contain 23.4 g of sodium chloride (400 meq each of na+ and cl - ) in water for injection, usp. the solution contains no bacteriostat, antimicrobial agent or added buffer. the additive may contain sodium hydroxide and/or hydrochloric acid for ph adjustment. the ph is 5.0 (4.5 to 7.0). the specific gravity is 1.15, and the osmolarity is 8.01 mosmol/l (calc). sodium chloride, usp is chemically designated nacl, a white crystalline compound freely soluble in water. the molecular weight is 58.44 g/mol. the pharmacy bulk package is a sterile dosage form which contains multiple single doses for preparation of admixtures for intravenous infusion (see dosage and administration ).
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/l. while the sodium ion can diffuse across cell membranes, the 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. sodium is the principal ion that determines osmotic pressure of interstitial fluids and the degree of tissue hydration. when serum sodium concentration is low, the secretion of antidiuretic hormone (adh) by the pituitary is inhibited, thereby preventi
Read more...ng 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.
How Supplied:
How supplied 23.4% sodium chloride injection, usp (4 meq/ml) is supplied as follows: ndc no type container dose / volume concentration 0409-1141-02 pharmacy bulk package â glass fliptop vial 400 meq/100 ml 4 meq/ml store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature].
Package Label Principal Display Panel:
Principal display panel - 100 ml vial label concentrate caution: must be diluted for intravenous use.* 23.4% sodium chloride injection, usp 400 meq/100 ml (4 meq/ml) rx only pharmacy bulk package â not for direct infusion. distributed by hospira, inc., lake forest, il 60045 usa principal display panel - 100 ml vial label