Infant Dextrose
Dextrose
Henry Schein, Inc.
Human Prescription Drug
NDC 0404-9844Infant Dextrose also known as Dextrose is a human prescription drug labeled by 'Henry Schein, Inc.'. National Drug Code (NDC) number for Infant Dextrose is 0404-9844. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Infant Dextrose drug includes Dextrose Monohydrate - 250 mg/mL . The currest status of Infant Dextrose drug is Active.
Drug Information:
| Drug NDC: | 0404-9844 |
| 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: | Infant 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 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Henry Schein, Inc. |
| 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 - 250 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: | 10 Jan, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 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: | NDA019445 |
| 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: | Henry Schein, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 727518
|
| 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 |
|---|
| 0404-9844-10 | 1 SYRINGE in 1 BAG (0404-9844-10) / 10 mL in 1 SYRINGE | 10 Jan, 2022 | 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:
Infant dextrose dextrose dextrose monohydrate anhydrous dextrose
Indications and Usage:
Indications and usage 25% dextrose injection is indicated in the treatment of acute symptomatic episodes of hypoglycemia in the neonate or older infant to restore depressed blood glucose levels and control symptoms. other drugs, such as epinephrine and glucagon, should be considered in patients unresponsive or intolerant to dextrose (glucose). oral feeding of dextrose may be necessary in infants with frequently recurring hypoglycemic episodes or to prevent recurrences due to hyperinsulinemia. 25% dextrose injection also provides a minimal source of carbohydrate calories.
Warnings:
Warnings 25% dextrose injection, usp is hypertonic and may cause phlebitis and thrombosis at the site of injection. significant hyperglycemia and possible hyperosmolar syndrome may result from too rapid administration. the physician should be aware of the symptoms of hyperosmolar syndrome, such as loss of consciousness.
Dosage and Administration:
Dosage and administration when possible, glucose concentrations of greater than 12% should be administered by central vein to reduce the risk for phlebitis and thrombosis. 25% dextrose injection, usp is administered only by slow intravenous injection. the dosage and constant infusion rate of intravenous dextrose must be selected with caution, particularly in neonates and low birth weight infants, because of the increased risk of hyperglycemia/ hypoglycemia. in the neonate, an injection of 250 to 500 mg (1 to 2 ml)/kg/dose (5 to 10 ml of 25% dextrose in a 5 kg infant) is recommended to control acute symptomatic hypoglycemia (tremors, convulsions,etc.). larger or repeated single doses (up to 10 or 12 ml of 25% dextrose) may be required in severe cases or older infants. a specimen for blood glucose determination should be taken before injecting the dextrose. in such emergencies, dextrose should be administered promptly without awaiting pretreatment test results. subsequent continuous intr
Read more...avenous infusion of 10% dextrose injection may be needed to stabilize blood glucose levels. further treatment should be guided by evaluation of the underlying disorder. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. see precautions.
Contraindications:
Contraindications a concentrated dextrose solution should not be used when intracranial or intraspinal hemorrhage is present.
Adverse Reactions:
Adverse reactions hyperosmolar syndrome, resulting from excessively rapid administration of concentrated dextrose may cause mental confusion and/or loss of consciousness. 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 and extravasation. 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 overdosage (hyperglycemia) during therapy, re-evaluate the patient and institute appropriate corrective measures. see warnings and precautions.
Description:
Description 25% dextrose injection, usp is a sterile, nonpyrogenic, hypertonic solution of dextrose in water for injection administered by intravenous injection to restore blood glucose levels in hypoglycemia and as a source of carbohydrate calories. each milliliter (ml) of fluid contains dextrose, hydrous, 250 mg which delivers 3.4 kcal/gram (0.85 kcal/ml). the solution has an osmolarity of 1.39 mosmol/ml (calc.). ph is 4.5 (3.2 to 6.5). may contain hydrochloric acid and sodium hydroxide for ph adjustment. the solution contains no bacteriostat, antimicrobial agent or added buffer (except for ph adjustment) and is intended only for use as a single-dose injection. when smaller doses are required the unused portion should be discarded with the entire unit. 25% dextrose injection, usp is a dextrose (glucose) and nutrient (carbohydrate) replenisher. dextrose, usp is chemically designated d-glucose monohydrate, (c6h12o6⢠h2o), a hexose sugar freely soluble in water. it has the following structural formula: the syringe is molded from a specially formulated polypropylene. water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. 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 syringe material. formula1.jpg
Clinical Pharmacology:
Clinical pharmacology when administered intravenously, this solution restores blood glucose levels in hypoglycemia and provides a source of carbohydrate calories. carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein-sparing action. dextrose injection undergoes oxidation to carbon dioxide and water. 25% dextrose injection, usp provides a concentrated solution sufficiently nonirritating for slow intravenous injection to infants for terminating acute symptomatic episodes of hypoglycemia in the neonate and in older infants (fasting blood glucose below 40 mg/100 ml). values as low as 20 mg/100 ml are not uncommon in normal asymptomatic infants the first few days of life (longer in premature infants). symptoms of hypoglycemia in the newborn and small infants may be difficult to evaluate and convulsions often are the first or only recognized manifestation of depressed blood glucose levels. because of widely varied etiology, the precise cause
Read more... may be difficult to establish. hypoglycemia (deficient blood glucose) due to organic or functional hyperinsulinism, may be only temporarily abated by administration of dextrose (glucose) and may rebound to hypoglycemia levels as release of additional insulin is evoked. in addition to various other causes, an idiopathic form of hypoglycemia in infancy has been described, as well as occasional transitory hypoglycemia in the neonatal period which disappears in later infancy. fetal hyperinsulinism in response to maternal hyperglycemia of diabetic mothers has been observed. occasionally convulsions associated with severe hypoglycemia are observed in infants of diabetic mothers. since glucose is the only sugar utilized for metabolic requirements of human neural tissue, it is essential to restore deficient blood glucose levels from any cause in order to prevent or correct central nervous system dysfunction.
How Supplied:
How supplied 25% dextrose injection, usp is supplied in single-dose containers as follows: store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature.] product repackaged by: henry schein, inc., bastian, va 24314 from original manufacturer/distributor's ndc and unit of sale to henry schein repackaged product ndc and unit of sale total strength/total volume (concentration) per unit ndc 0409-1775-10 bundle of 10 ansyr⢠plastic syringes single-dose containers ndc 0404-9844-10 1 10 ml single-dose syringe in a bag (syringe bears ndc 0409-1775-40) 2.5 g/10 ml (250 mg/ml) distributed by hospira, inc., lake forest, il 60045 usa lab-1057-4.0 revised: august 2020 image1.jpg
Package Label Principal Display Panel:
Sample package label label1.jpg