5% Dextrose
Hf Acquisition Co Llc, Dba Healthfirst
Human Prescription Drug
NDC 51662-12115% Dextrose is a human prescription drug labeled by 'Hf Acquisition Co Llc, Dba Healthfirst'. National Drug Code (NDC) number for 5% Dextrose is 51662-1211. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in 5% Dextrose drug includes Dextrose Monohydrate - 5 g/100mL . The currest status of 5% Dextrose drug is Active.
Drug Information:
| Drug NDC: | 51662-1211 |
| 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: | 5% 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: | 5% Dextrose |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Hf Acquisition Co Llc, Dba Healthfirst |
| 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
|
| 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: | 18 Oct, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 28 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: | NDA016367 |
| 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: | HF Acquisition Co LLC, DBA HealthFirst
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1795607
|
| 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. |
| 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 NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 51662-1211-1 | 1 BAG in 1 POUCH (51662-1211-1) / 500 mL in 1 BAG | 18 Oct, 2018 | 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:
5% dextrose 5% dextrose dextrose monohydrate anhydrous dextrose water
Indications and Usage:
Indications & 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 & 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 .) instructions for use to open: tear outer wrap at notch and remove solution container. if supplemental medication is desired, follow directions below before preparing for administration. to add medication 1. prepare additive port. 2. using aseptic technique and an additive delivery n
Read more...eedle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. withdraw needle after injecting medication. 3. the additive port may be protected by covering with an additive cap. 4. mix container contents thoroughly. preparation for administration (use aseptic technique) 1. close flow control clamp of administration set. 2. remove cover from outlet port at bottom of container. 3. insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. note: when using a vented administration set, replace bacterial retentive air filter with piercing pin cover. insert piercing pin with twisting motion until shoulder of air filter housing rests against the outlet port flange. 4. suspend container from hanger. 5. squeeze and release drip chamber to establish proper fluid level in chamber. 6. attach venipuncture device to set. 7. open clamp to expel air from set and venipuncture device. close clamp. 8. perform venipuncture. 9. regulate rate of administration with flow control clamp. warning: do not use flexible container in series connections.
Contraindications:
Contraindications dextrose injection 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.
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 injection, usp solutions are sterile and nonpyrogenic. they are parenteral solutions containing various concentrations of dextrose in water for injection intended for intravenous administration. each 100 ml of 5% dextrose injection, usp, contains dextrose, hydrous 5 g in water for injection. the caloric value is 170 kcal/l. the osmolarity is 252 mosmol/l (calc.), which is slightly hypotonic. each 100 ml of 10% dextrose injection, usp, contains dextrose, hydrous 10 g in water for injection. the caloric value is 340 kcal/l. the osmolarity is 505 mosmol/l (calc.), which is hypertonic. the ph for both concentrations is 4.3 (3.2 to 6.5). 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 and nutrient replenishers. dextrose, usp is chemically designated d-glucose monohydrate (c6h12o6 ⢠h2o), a hexose sugar freely soluble in water. it has the following structural formula: water for injection, usp is chemically designated h2o. the flexible plastic container is fabricated from a specially formulated polyvinylchloride. water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. exposure to temperatures above 25°c/77°f during transport and storage will lead to minor losses in moisture content. higher temperatures lead to greater losses. it is unlikely that these minor losses will lead to clinically significant changes within the expiration period. structure
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 (1.0 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 bo
Read more...dy compartments and sodium (na+) plays a major role in maintaining physiologic equilibrium.
How Supplied:
How supplied 5% dextrose injection is supplied in the following dosage forms. ndc 51662-1211-1 5% dextrose injection, usp 500ml bag hf acquisition co llc, dba healthfirst mukilteo, wa 98275 also supplied in the following manufactures dosage forms dextrose injection, usp is supplied in single-dose flexible plastic containers in various sizes and concentrations as shown in the accompanying table. store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature.] protect from freezing. revised: june, 2010 printed in usa en-2531 hospira, inc., lake forest, il 60045 usa how supplied tabel logo
Package Label Principal Display Panel:
Principal display panel, 500 ml bag 500 ml bag
Principal display panel, 500 ml serialized pouch serialized label