Dextrose

Dextrose Monohydrate


Fresenius Kabi Usa, Llc
Human Prescription Drug
NDC 65219-238
Dextrose also known as Dextrose Monohydrate is a human prescription drug labeled by 'Fresenius Kabi Usa, Llc'. National Drug Code (NDC) number for Dextrose is 65219-238. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Dextrose drug includes Dextrose Monohydrate - 12500 mg/250mL . The currest status of Dextrose drug is Active.

Drug Information:

Drug NDC: 65219-238
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
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
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 - 12500 mg/250mL
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: 21 Oct, 2016
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 21 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: ANDA207449
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:1795607
1795609
1795610
1795616
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
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
65219-238-2530 BAG in 1 CASE (65219-238-25) / 250 mL in 1 BAG (65219-238-01)10 Nov, 2021N/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 dextrose monohydrate dextrose monohydrate anhydrous dextrose dextrose dextrose monohydrate dextrose monohydrate anhydrous dextrose dextrose dextrose monohydrate dextrose monohydrate anhydrous dextrose water dextrose dextrose monohydrate dextrose monohydrate anhydrous dextrose 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. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (see precautions ).

Indications and Usage:

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

Warnings:

Warnings: excessive administration of potassium-free solutions may result in significant hypokalemia. 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. drug interactions additives may be incompatible. consult with pharmacist, if available. when introducing additives, use aseptic technique, mix thoroughly and do not store. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (see precautions ).

Contraindications:

Contraindications: 5% dextrose injection, usp without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur.

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. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (see precautions ).

Use in Pregnancy:

Pregnancy teratogenic effects pregnancy category c. animal reproduction studies have not been conducted with dextrose. it is also not known whether dextrose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. dextrose 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 osmolarity 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.

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: 5% dextrose injection, usp solution is sterile and nonpyrogenic. it is a parenteral solution containing dextrose in water for injection intended for intravenous administration. each 100 ml of 5% dextrose injection, usp, contains dextrose monohydrate, 5 g in water for injection. the caloric value is 170 kcal/l. the osmolarity is 252 mosmol/l (calc.), which is slightly hypotonic. the solution ph is 4.3 (3.2 to 6.5). this solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. when smaller doses are required the unused portion should be discarded. 5% dextrose injection, usp is a parenteral fluid and nutrient replenisher. 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: 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 free flex ® + bag has a needle-free injection port and can accept standard luer lock syringes to add medication. 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 and carbohydrate. isotonic and hypertonic concentrations of dextrose are suitable for parenteral maintenance of water requirements when salt is not needed or should be avoided. 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. 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 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 bo
dy compartments and sodium (na + ) plays a major role in maintaining physiologic equilibrium.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility studies with 5% dextrose injection, usp have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

How Supplied:

How supplied: 5% dextrose injection, usp is supplied in single dose flexible plastic containers as follows: product code unit of sale strength each 252300 ndc 65219-234-10 package of 60 free flex ® + bags 2.5 grams per 50 ml (50 mg per ml) ndc 65219-234-01 50 ml in a 100 ml free flex ® + bag 262300 ndc 65219-236-10 package of 50 free flex ® + bags 5 grams per 100 ml (50 mg per ml) ndc 65219-236-01 100 ml free flex ® + bag 262325 ndc 65219-238-25 package of 30 freeflex ® bags 12.5 grams per 250 ml (50 mg per ml) ndc 65219-238-01 one 250 ml freeflex ® bag 262450 ndc 65219-240-50 package of 20 freeflex ® bags 25 grams per 500 ml (50 mg per ml) ndc 65219-240-01 one 500 ml freeflex ® bag store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. exposure of pharmaceutical products to heat should be minimized. avoid excessive heat. protect from freezing. the container closure is not made with natural rubber latex. non-pvc, non-dehp, sterile.
manufactured for: lake zurich, il 60047 www.fresenius-kabi.com/us issued: september 2021 figure

Package Label Principal Display Panel:

Package label - principal display – 5% dextrose 50 ml bag label free flex ® + ndc 65219-234-01 5% dextrose injection, usp 2.5 grams per 50 ml (50 mg per ml) for intravenous use. rx only package label - principal display – 5% dextrose 50 ml bag label

Package label - principal display – 5% dextrose 50 ml case label ndc 65219-234-10 252300 5% dextrose injection, usp 50 ml x 60 store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. protect from freezing. package label - principal display – 5% dextrose 50 ml case label

Package label - principal display – 5% dextrose 100 ml bag label free flex ® + ndc 65219-236-01 5% dextrose injection, usp 5 grams per 100 ml (50 mg per ml) for intravenous use. rx only package label - principal display – 5% dextrose 100 ml bag label

Package label - principal display – 5% dextrose 100 ml case label ndc 65219-236-10 262300 5% dextrose injection, usp 100 ml x 50 store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. protect from freezing. package label - principal display – 5% dextrose 100 ml case label

Package label - principal display – 5% dextrose 250 ml bag label ndc 65219-238-01 5% dextrose injection, usp 12.5 grams per 250 ml (50 mg per ml) for intravenous use. rx only package label - principal display – 5% dextrose 50 ml case label

Package label - principal display – 5% dextrose 250 ml case label ndc 65219-238-25 262325 5% dextrose injection, usp 250 ml x 30 store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. protect from freezing. package label - principal display – 5% dextrose 250 ml case label

Package label - principal display – 5% dextrose 500 ml bag label ndc 65219-240-01 5% dextrose injection, usp 25 grams per 500 ml (50 mg per ml) for intravenous use. rx only package label - principal display – 5% dextrose 500 ml bag label

Package label - principal display – 5% dextrose 500 ml case label ndc 65219-240-50 262450 5% dextrose injection, usp 500 ml x 20 store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. protect from freezing. package label - principal display – 5% dextrose 500 ml case label


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