Dextrose 40 g/100mL Injection, Solution
Other active recalls for Dextrose (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Other irrigating solutions class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Dextrose is essentially glucose — sugar — given directly into a vein. In an emergency, it's used to quickly raise dangerously low blood sugar, which can happen with too much insuli...
- Specific formulations — Infant Dextrose (25%) and Dextrose (25% injection) — are FDA-approved to treat low blood sugar in newborns and infants up to 2 years old. That said, prematu...
- Is dextrose safe for my baby or newborn?
- The most common issues are high blood sugar, vein irritation or clotting at the IV site, low sodium in the blood, and infection. More serious — but less common — reactions include...
Patient education
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
1 inactive ingredient listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dextrose 40 g/100mLthis 00990-7937-19 | ICU | 12 pouches | — | — | FDA listed | — |
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⏳ Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
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🔬 Reported adverse events (FAERS)
Top reported reactions
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00990-7937-19 You're viewing this | 12 POUCH in 1 CASE (0990-7937-19) / 1 BAG in 1 POUCH / 500 mL in 1 BAG | 2019-10-01 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient or contraindicated ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • Must be diluted with compatible intravenous fluids or used as admixture, prior to administration. Not for direct intravenous infusion . ( 2.1 ) • Only for slow intravenous infusion only into a: ( 2.1 ) o Central vein , if final dextrose concentration is greater than 5% or osmolality is greater than 900 mOsm/L o Peripheral vein , if final dextrose concentration 5% or less and osmolality is less than 900 mOsm/L • Individualize dosage based on the patient's clinical condition, body weight, nutritional/fluid requirements, as well as additional energy given orally/enterally ( 2.2 ) • Discontinue infusion of concentrated dextrose solutions slowly and/or administer 5% dextrose ( 2.3 )
2.1Important Preparation and Administration Instructions Dextrose Injection is supplied in the following five strengths: 20%, 30%, 40%, 50% and 70% [see How Supplied/Storage and Handling ( 16 )] . Prior to administration, Dextrose Injection must be diluted with other compatible intravenous fluids or used as an admixture with amino acids. It is not for direct intravenous infusion .
Preparation Prior to Administration • Because additives may be incompatible, evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. Consult with a pharmacist, if available. If it is deemed advisable to introduce additives, use aseptic technique and mix thoroughly. • Inspect Dextrose Injection to ensure precipitates have not formed during the mixing or addition of additives.
Discard the bag if precipitates are observed. Some opacity of the plastic container (due to moisture absorption during sterilization process) may be observed. This is normal and does not affect the solution quality or safety.
The opacity will diminish gradually. • Use promptly after admixing or dilution. • For single use only; discard unused portion Important Administration Instructions • Set the vent to the closed position on a vented intravenous administration set to prevent air embolism. • Use a dedicated line without any connections to avoid air embolism. • Prior to infusion, visually inspect the diluted dextrose solution for particulate matter. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear and container is undamaged. • The choice of a central or peripheral venous route of infusion should depend on the osmolarity of the final infusate.
Solutions with greater than 5% dextrose or with osmolarity of greater than or equal to 900 mOsm/L must be infused through a central catheter [see Warnings and Precautions ( 5.5 )] .
2.2Dosing Information Caution: Dextrose Injection is not for direct intravenous infusion. Prior to administration, Dextrose Injection must be diluted with other compatible intravenous fluids or used as an admixture with amino acids. Individualize the dosage of Dextrose Injection based on the patient's clinical condition (ability to adequately metabolize dextrose), body weight, nutritional and fluid requirements, as well as additional energy given orally or enterally to the patient.
The administration rate should be governed, especially during the first few day of therapy, by the patient's tolerance to dextrose. Daily intake of amino acids and dextrose should be increased gradually to the maximum required dose as indicated by frequent determinations of blood glucose levels.
2.3Discontinuation of Dextrose Injection To reduce the risk of hypoglycemia, a gradual decrease in flow rate in the last hour of infusion should be considered.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Dextrose Injection 20%, 30%, 40%, 50%, and 70% USP are sterile, non-pyrogenic, hypertonic solutions of dextrose in single-dose, partial-fill, flexible containers. 500 mL fill volume in 1000 mL flexible container • 20% (0.2 grams/mL): 20 grams of dextrose hydrous per 100 mL • 30% (0.3 grams/mL): 30 grams of dextrose hydrous per 100 mL • 40% (0.4 grams/mL): 40 grams of dextrose hydrous per 100 mL • 50% (0.5 grams/mL): 50 grams of dextrose hydrous per 100 mL • 70% (0.7 grams/mL): 70 grams of dextrose hydrous per 100 mL Injection: Single-dose, partial-fill, flexible containers with ( 3 ): 500 mL fill volume in 1000 mL flexible container: • 20% (0.2 grams/mL): 20 grams of dextrose hydrous per 100 mL • 30% (0.3 grams/mL): 30 grams of dextrose hydrous per 100 mL • 40% (0.4 grams/mL): 40 grams of dextrose hydrous per 100 mL • 50% (0.5 grams/mL): 50 grams of dextrose hydrous per 100 mL • 70% (0.7 grams/mL): 70 grams of dextrose hydrous per 100 mL
⛔ Contraindications ▾
4 CONTRAINDICATIONS The use of Dextrose Injection is contraindicated in patients: • who are severely dehydrated as hypertonic dextrose solution can worsen the patient's hyperosmolar state. • with known hypersensitivity to dextrose [see Warnings and Precautions (5.2) ] . • Severe dehydration ( 4 ) • Known hypersensitivity to dextrose ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Hyperglycemia or Hyperosmolar Hyperglycemic State : Monitor blood glucose and administer insulin as needed ( 5.1 ) • Hypersensitivity Reactions : Monitor for signs and symptoms and discontinue infusion if reactions occur ( 5.2 ) • Risk of Infection : Monitor for signs and symptoms and laboratory parameters ( 5.3 ) • Refeeding Syndrome : Monitory laboratory parameters ( 5.4 ) • Vein Damage and Thrombosis : Administer solutions containing more than 5% dextrose as the final concentration or solutions with an osmolarity ≥ 900 mOsm/L through a central vein ( 2.1 , 5.5 ) • Aluminum Toxicity : Dextrose Injection contains aluminum that may be toxic.
Patients with impaired renal function, and preterm infants, at higher risk. Limit aluminum to less than 4 mcg/kg/day ( 5.6 , 8.4 ) • Parenteral Nutrition Associated Liver Disease : increased risk in patients who receive parenteral nutrition for extended periods of time, especially preterm infants; monitor liver function tests, if abnormalities occur consider discontinuation or dosage reduction. ( 5.7 , 8.4 ) • Electrolyte Imbalance and Fluid Overload : monitor daily fluid balance, blood electrolyte levels, correct as needed.
( 5.8 , 8.4 )
5.1Hyperglycemia and Hyperosmolar Hyperglycemic State The use of dextrose infusions in patients with diabetes mellitus or impaired glucose tolerance may worsen hyperglycemia. Administration of dextrose at a rate exceeding the patient's utilization rate may lead to hyperglycemia, coma, and death. Patients with underlying confusion and renal impairment who receive dextrose infusions, may be at greater risk of developing hyperosmolar hyperglycemic state.
Monitor blood glucose levels and treat hyperglycemia to maintain optimum levels while administering Dextrose Injection. Insulin may be administered or adjusted to maintain optimal blood glucose levels during Dextrose Injection administration.
5.2Hypersensitivity Reactions Hypersensitivity reactions including anaphylaxis have been reported with dextrose infusions. Stop infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity reaction develop. Signs or symptoms may include: tachypnea, dyspnea, hypoxia, bronchospasm, tachycardia, hypotension, cyanosis, vomiting, nausea, headache, sweating, dizziness, altered mentation, flushing, rash, urticaria, erythema, pyrexia, and chills.
5.3Risk of Infections Patients who require parenteral nutrition are at high risk of infections because the nutritional components of these solutions can support microbial growth. The risk of infection is increased in patients with malnutrition-associated immunosuppression, hyperglycemia exacerbated by dextrose infusion, long-term use and poor maintenance of intravenous catheters, or immunosuppressive effects of other concomitant conditions, drugs, or other components of the parenteral formulation (e.g., lipid emulsion).
To decrease the risk of infectious complications, ensure aseptic technique in catheter placement and maintenance, as well as aseptic technique in the preparation and administration of the nutritional formula. Monitor for signs and symptoms (including fever and chills) of early infections, including laboratory test results (including leukocytosis and hyperglycemia) and frequent checks of the parenteral access device and insertion site for edema, redness and discharge.
5.4Refeeding Syndrome Refeeding severely undernourished patients may result in refeeding syndrome, characterized by the intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop. To prevent these complications, monitor severely undernourished patients and slowly increase nutrient intakes.
5.5Vein Damage and Thrombosis Dextrose Injection is for admixture with amino acids or dilution with other compatible intravenous fluids. It is not for direct intravenous infusion. Administer solutions containing more…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions from voluntary reports or clinical studies have been reported with Dextrose Injection. Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. • Hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions ( 5.1 )] . • Hypersensitivity reactions [see Warnings and Precautions ( 5.2 )] . • Risk of infections [see Warnings and Precautions ( 5.3 )] . • Refeeding syndrome [see Warnings and Precautions ( 5.4 )] . • Vein damage and thrombosis [see Warnings and Precautions ( 5.5 )] . • Aluminum toxicity [see Warnings and Precautions ( 5.6 )] . • Risk of parenteral nutrition associated liver disease [see Warnings and Precautions ( 5.7 )] . • Electrolyte imbalance and fluid overload [see Warnings and Precautions ( 5.8 )] .
The most common adverse reactions are hyperosmolar syndrome, infection both systemic and at the injection site, vein thrombosis or phlebitis, and hypervolemia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact ICU Medical, Inc. at 1-800-441-4100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pediatric Use: Increased risk of hypoglycemia/hyperglycemia; monitor serum glucose concentrations. ( 8.4 )
8.1Pregnancy Risk Summary There are no data with Dextrose Injection in pregnant women. In addition, animal reproduction studies have not been conducted with dextrose. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Consider parenteral nutrition in cases of severe maternal malnutrition where nutritional requirements cannot be fulfilled by the enteral route because of the risks to the fetus associated with severe malnutrition, including preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations, and perinatal mortality.
8.2Lactation There are no data regarding the presence of dextrose in human milk, the effects on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Dextrose Injection and any potential adverse effects on the breastfed infant from Dextrose Injection or from the underlying maternal condition.
8.4Pediatric Use Neonates, especially those born premature and with low birth weight are at increased risk of developing hypo – or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose infusions to ensure adequate glycemic control in order to avoid potential long term adverse effects. Hypoglycemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycemia has been associated with intraventricular hemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged length of hospital stay, and death.
Plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes. In very low birth weight infants, excessive or rapid administration of Dextrose Injection may result in increased serum osmolality and possible intracerebral hemorrhage. Because of immature renal function, preterm infants receiving prolonged treatment with Dextrose Injection, may be at risk aluminum toxicity [see Warnings and Precautions ( 5.6 )] .
Patients, including pediatric patients, may be at risk for Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions ( 5.7 )] .
8.5Geriatric Use Clinical studies of Dextrose Injection did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from other younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no data with Dextrose Injection in pregnant women. In addition, animal reproduction studies have not been conducted with dextrose. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Consider parenteral nutrition in cases of severe maternal malnutrition where nutritional requirements cannot be fulfilled by the enteral route because of the risks to the fetus associated with severe malnutrition, including preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations, and perinatal mortality.
🧒 Pediatric Use ▾
8.4Pediatric Use Neonates, especially those born premature and with low birth weight are at increased risk of developing hypo – or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose infusions to ensure adequate glycemic control in order to avoid potential long term adverse effects. Hypoglycemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycemia has been associated with intraventricular hemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged length of hospital stay, and death.
Plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes. In very low birth weight infants, excessive or rapid administration of Dextrose Injection may result in increased serum osmolality and possible intracerebral hemorrhage. Because of immature renal function, preterm infants receiving prolonged treatment with Dextrose Injection, may be at risk aluminum toxicity [see Warnings and Precautions ( 5.6 )] .
Patients, including pediatric patients, may be at risk for Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions ( 5.7 )] .
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of Dextrose Injection did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from other younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
🆘 Overdosage ▾
10 OVERDOSAGE An increased infusion rate of Dextrose Injection or administration of a concentrated dextrose solution can cause hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance [see Warnings and Precautions ( 5.1 , 5.8 )] . Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal. Discontinue infusion and institute appropriate corrective measures in the event of overhydration or solute overload during therapy, with particular attention to respiratory and cardiovascular systems .
For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Dextrose Injection is used to supplement nutrition by providing glucose parenterally. Dextrose is oxidized to carbon dioxide and water, yielding energy.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Dextrose Injection is used to supplement nutrition by providing glucose parenterally. Dextrose is oxidized to carbon dioxide and water, yielding energy.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Dextrose Injection, 20%, 30%, 40%, 50%, and 70% USP are sterile hypertonic solutions of dextrose supplied in single-dose, partial-fill flexible containers (see Tables 1 and 2 ) for intravenous administration after appropriate admixture or dilution [see Dosage and Administration ( 2.1 )] . Do not remove container from the overwrap until intended for use. Table 2: Strengths, Fill Volume, and NDC # of Dextrose Injection 20%, 30%, 40%, 50%, and 70% Strength Fill Volume NDC# 20% (0.2 grams/mL) 500 mL 0409-7935-19 0990-7935-19 30% (0.3 grams/mL) 500 mL 0409-8004-15 0990-8004-15 40% (0.4 grams/mL) 500 mL 0409-7937-19 0990-7937-19 50% (0.5 grams/mL) 500 mL 0409-7936-19 0990-7936-19 70% (0.7 grams/mL) 500 mL 0409-7918-19 0990-7918-19 ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code.
Both NDC codes are expected to be in the market for a period of time. Use the product immediately after mixing and the introduction of additives. Store between 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.] Do not freeze.
📋 Description ▾
11 DESCRIPTION Dextrose Injection, USP 20%, 30%, 40%, 50% and 70% are sterile, nonpyrogenic, hypertonic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after appropriate admixture or dilution [see Dosage and Administration ( 2.1 )] . Partial-fill containers, designed to facilitate admixture or dilution to provide dextrose in various concentrations, are available in various sizes. See Table 1 for the content and characteristics of these concentrated solutions .
The solutions contain no bacteriostatic, antimicrobial agent or added buffer and are intended only for use as a single-dose injection following admixture or dilution. The pH is 4.3 (range is 3.2 to 6.5). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly.
Table 1. Contents and Characteristics of Dextrose Injection 20%, 30%, 40%, 50%, and 70% Strength Fill Volume Amount of Dextrose Hydrous per Container kcal Caloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous. per Container mOsmol per liter 20% (0.2 grams/mL) 500 mL 100 grams 340 1009 30% (0.3 grams/mL) 500 mL 150 grams 510 1514 40% (0.4 grams/mL) 500 mL 200 grams 680 2018 50% (0.5 grams/mL) 500 mL 250 grams 850 2523 70% (0.7 grams/mL) 500 mL 350 grams 1190 3532 Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water.
The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula: Dextrose may be derived from corn. Water for Injection, USP is chemically designated H 2 O.
Dextrose Injection contains no more than 25 mcg/L of aluminum. Structural Formula for Dextrose Injection, USP
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Inform patients, caregivers, or home healthcare providers of the following risks of Dextrose Injection: • Hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions ( 5.1 )] • Hypersensitivity reactions [see Warnings and Precautions ( 5.2 )] • Risk of infection [see Warnings and Precautions ( 5.3 )] • Vein damage and thrombosis [see Warnings and Precautions ( 5.5 )] • Aluminum toxicity [see Warnings and Precautions ( 5.6 )] • Risk of parenteral nutrition associated liver disease [see Warnings and Precautions ( 5.7 )] • Fluid overload and electrolyte imbalance [see Warnings and Precautions ( 5.8 )] EN-4695 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA