Dextrose And Sodium Chloride

Dextrose Monohydrate And Sodium Chloride


Fresenius Kabi Usa, Llc
Human Prescription Drug
NDC 63323-867
Dextrose And Sodium Chloride also known as Dextrose Monohydrate And Sodium Chloride is a human prescription drug labeled by 'Fresenius Kabi Usa, Llc'. National Drug Code (NDC) number for Dextrose And Sodium Chloride is 63323-867. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Dextrose And Sodium Chloride drug includes Dextrose Monohydrate - 5 g/100mL Sodium Chloride - .3 g/100mL . The currest status of Dextrose And Sodium Chloride drug is Active.

Drug Information:

Drug NDC: 63323-867
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: Dextrose And 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: Dextrose Monohydrate And 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:DEXTROSE MONOHYDRATE - 5 g/100mL
SODIUM CHLORIDE - .3 g/100mL
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: 26 Oct, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 20 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: ANDA211194
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:1795147
1795149
1795150
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:LX22YL083G
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
63323-867-1010 BAG in 1 CASE (63323-867-10) / 1000 mL in 1 BAG26 Oct, 2020N/ANo
63323-867-7420 BAG in 1 CASE (63323-867-74) / 500 mL in 1 BAG26 Oct, 2020N/ANo
63323-867-7530 BAG in 1 CASE (63323-867-75) / 250 mL in 1 BAG26 Oct, 2020N/ANo
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:

Dextrose and sodium chloride dextrose monohydrate and sodium chloride dextrose monohydrate anhydrous dextrose sodium chloride sodium cation chloride ion water

Drug Interactions:

Drug interactions additives may be incompatible. consult with pharmacist, if available. when introducing additives, use aseptic technique, mix thoroughly and do not store.

Indications and Usage:

Indications and usage intravenous solutions containing dextrose and sodium chloride are indicated for parenteral replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient.

Warnings:

Warnings 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. excessive administration of potassium-free solutions may result in significant hypokalemia. in patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention. the intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. the risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. the risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.

Dosage and Administration:

Dosage and administration the dose is dependent upon the age, weight and clinical condition of the patient. as reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. see precautions . drug interactions additives may be incompatible. consult with pharmacist, if available. when introducing additives, use aseptic technique, mix thoroughly and do not store.

Contraindications:

Contraindications none known.

Adverse Reactions:

Adverse reactions reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. if an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

Drug Interactions:

Drug interactions additives may be incompatible. consult with pharmacist, if available. when introducing additives, use aseptic technique, mix thoroughly and do not store.

Use in Pregnancy:

Pregnancy category c. animal reproduction studies have not been conducted with dextrose or sodium chloride. it is also not known whether dextrose or sodium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. dextrose or sodium chloride should be given to a pregnant woman only if clearly needed.

Pediatric Use:

Pediatric use. the safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. in neonates or very small infants, the volume of fluid may affect fluid and electrolyte balance. frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. in very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.

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. sodium ions are known to be substantially excreted by the kidney, and the risk of toxic reactions 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 , precautions , and adverse reactions .

Description:

Description dextrose and sodium chloride injection, usp solutions are sterile and nonpyrogenic. they are large volume parenteral solutions containing 5 grams per 100 ml of dextrose and 0.3 grams per 100 ml of sodium chloride in water for injection intended for intravenous administration. see table for summary of content and characteristics of these solutions. the solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only as a single-dose injection. when smaller doses are required the unused portion should be discarded. the solutions are parenteral fluid, nutrient and electrolyte replenishers. dextrose, usp is chemically designated d-glucose monohydrate (c 6 h 12 o 6 • h 2 o), a hexose sugar freely soluble in water. it has the following structural formula: sodium chloride, usp is chemically designated nacl, a white crystalline powder freely soluble in water. water for injection, usp is chemically designated h 2 o. the flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (free flex ® bag). the amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. the suitability of the container material has been confirmed by tests in animals according to usp biological tests for plastic containers. structural formula

Clinical Pharmacology:

Clinical pharmacology when administered intravenously, these solutions provide a source of water, carbohydrate and electrolytes. solutions which provide combinations of hypotonic or isotonic concentrations of dextrose and of sodium chloride are suitable for parenteral maintenance or replacement of water and electrolyte requirements with minimal carbohydrate calories. solutions containing carbohydrate in the form of dextrose restore blood glucose levels and provide calories. carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein-sparing action. dextrose injected parenterally undergoes oxidation to carbon dioxide and water. sodium chloride in water dissociates to provide sodium (na + ) and chloride (cl¯) ions. sodium (na + ) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. chloride (cl¯) has an integral role in buffering action when oxygen and carbon diox
ide 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. water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. average normal adult daily requirements range from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). water balance is maintained by various regulatory mechanisms. water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (na + ) plays a major role in maintaining physiologic equilibrium.

How Supplied:

How supplied dextrose and sodium chloride injection, usp are supplied in single-dose flexible plastic containers in various sizes as shown in the accompanying table. content and characteristics grams/100 ml per 1000 ml product code ndc no. product dextrose (hydrous) sodium chloride sodium na + chloride cl – caloric tonicity osmolarity mosmol/l (calc) ph container 867175 63323-867-75 5% dextrose and 0.3% sodium chloride inj., usp 5 0.3 51 meq 51 meq 170 hypertonic 355 4.3 (3.5 to 6.5) 250 ml bag 867174 63323-867-74 5% dextrose and 0.3% sodium chloride inj., usp 5 0.3 51 meq 51 meq 170 hypertonic 355 4.3 (3.5 to 6.5) 500 ml bag 867110 63323-867-10 5% dextrose and 0.3% sodium chloride inj., usp 5 0.3 51 meq 51 meq 170 hypertonic 355 4.3 (3.5 to 6.5) 1000 ml bag the container closure is not made with natural rubber latex. non-pvc, non-dehp, sterile. protect from freezing. store at 20° to 25°c (68° to 77°f). [see usp controlled room temperature.]. manufactured for: lake zur
ich, il 60047 made in germany 451679 www.fresenius-kabi.com/us issued: september 2020 fresenius kabi logo

Package Label Principal Display Panel:

Package label - principal display – dextrose and sodium chloride 250 ml bag label ndc 63323-867-75 250 ml 5% dextrose and 0.3% sodium chloride injection, usp for intravenous use. rx only freeflex logo package label - principal display – dextrose and sodium chloride 250 ml bag label

Package label - principal display – dextrose and sodium chloride 500 ml bag label ndc 63323-867-74 500 ml 5% dextrose and 0.3% sodium chloride injection, usp for intravenous use. rx only freeflex logo package label - principal display – dextrose and sodium chloride 500 ml bag label

Package label - principal display – dextrose and sodium chloride 1000 ml bag label ndc 63323-867-10 1000 ml 5% dextrose and 0.3% sodium chloride injection, usp for intravenous use. rx only freeflex logo package label - principal display – dextrose and sodium chloride 1000 ml bag label


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