Dextrose 70 g/100mL Injection, Solution
Other active recalls for Dextrose Monohydrate (different manufacturers) — 3 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Other irrigating solutions class.
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🏭 Manufacturer & labeler
Where does this data come from?
🩺 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
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
Where does this data come from?
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 | $0.2435 | $2,922.00 / 12000 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J7799 | No ASP payment limit on file for J7799 this quarter. | |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dextrose 70 g/100mL 00264-7387-50 | B. | 2000 ml | — | AP | FDA listed | — |
| Dextrose 70 g/100mL 00338-0719-06 | Baxter | 2000 ml | — | AP | FDA listed | — |
| Dextrose 70 g/100mLthis 00990-7120-07 | ICU | 6 pouches | — | AP | FDA listed | — |
| Dextrose 70 g/100mL 00990-7918-19 | ICU | 12 pouches | — | AP | FDA listed | — |
Where does this data come from?
⏳ 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.
Where does this data come from?
🗺️ Medicaid utilization & spend
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00990-7120-07 You're viewing this | 6 POUCH in 1 CASE (0990-7120-07) / 1 BAG in 1 POUCH / 2000 mL in 1 BAG | 2019-07-01 | 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 | — Not published for this NDC No photo available yet for this listing. |
| 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 | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
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Do I need a prescription for this product?
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE 70% Dextrose Injection, USP (concentrated dextrose in water) in Pharmacy Bulk Packages is indicated for use with automated compounding devices for preparing intravenous nutritional admixtures in the pharmacy.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Concentrated Dextrose in Water is administered by slow intravenous infusion (a) after admixture with amino acid solutions or (b) after dilution with other compatible IV fluids. Dosage should be adjusted to meet the requirements of each individual patient. 70% Dextrose Injection, USP in the 2000 mL flexible Pharmacy Bulk Package is designed for use with automated compounding devices for preparing intravenous nutritional admixtures.
Dosages will be in accordance with the recommendation of the prescribing physician. 70% Dextrose Injection, USP are not intended for direct infusion. Admixtures should be made by, or under the direction of, a pharmacist using strict aseptic technique under a laminar flow hood.
Compounded admixtures may be stored under refrigeration for up to 24 hours. Administration of admixtures should be completed within 24 hours after removal from refrigeration. The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg of body weight/hr.
About 95% of the dextrose is retained when infused at a rate of 0.8 g/kg/hr. Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. 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 with the fluid withdrawn from this container. Consult with pharmacist, if available.
When compounding admixtures, use aseptic technique, mix thoroughly and do not store. Some opacity of the plastic 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. Recommended Directions for Use of the Pharmacy Bulk Package Use Aseptic Technique 1. During use, container must be stored, and all manipulations performed, in an appropriate laminar flow hood.
2. Remove cover from outlet port at bottom of container. 3.
Insert piercing pin of transfer set and suspend unit in a laminar flow hood. Insertion of a piercing pin into the outlet port should be performed only once in a Pharmacy Bulk Package solution. Once the outlet site has been entered, the withdrawal of container contents should be completed promptly in one continuous operation.
Should this not be possible, a maximum time of 4 hours from transfer set pin or implement insertion is permitted to complete fluid transfer operations; i.e., discard container no later than 4 hours after initial closure puncture. 4. Sequentially dispense aliquots of 70% Dextrose Injection, USP into IV containers using appropriate transfer set.
During fluid transfer operations, the Pharmacy Bulk Package should be maintained under the storage conditions recommended in the labeling.
⛔ Contraindications ▾
CONTRAINDICATIONS A concentrated dextrose solution should not be used when intracranial or intraspinal hemorrhage is present nor in the presence of delirium tremens if the patient is already dehydrated. 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.
⚠️ Warnings ▾
WARNINGS Concentrated dextrose in water should be administered only after suitable dilution. Hypertonic dextrose solutions should be given slowly. 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 mental confusion and loss of consciousness, especially in patients with chronic uremia and those with known carbohydrate intolerance. 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. WARNING : This product contains aluminum that may be toxic.
Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity.
Tissue loading may occur at even lower rates of administration. FOR PERIPHERAL VEIN ADMINISTRATION Hypertonic dextrose solutions (above 5% concentration) should be given slowly, preferably through a small bore needle into a large vein, to minimize venous irritation. FOR CENTRAL VENOUS ADMINISTRATION Concentrated dextrose should be administered via central vein after appropriate admixture or dilution when required.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Hyperosmolar syndrome, resulting from excessively rapid administration of concentrated dextrose may cause hypovolemia, dehydration, 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, 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 during therapy, re-evaluate the patient and institute appropriate corrective measures. (See WARNINGS and PRECAUTIONS ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY When administered intravenously, 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 injection 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 requirement ranges 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 / Storage and Handling ▾
HOW SUPPLIED 70% Dextrose Injection, USP are supplied as follows: NDC No. Container Concentration Fill 0409-7120-07 Flexible Pharmacy Bulk Package 70% 2000 mL 0990-7120-07 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.
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: June 2018 EN-4656 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA
📋 Description ▾
DESCRIPTION 70% Dextrose Injection, USP (concentrated dextrose in water) is a sterile, nonpyrogenic, hypertonic solution of Dextrose, USP in water for injection for intravenous administration after appropriate admixture or dilution. The Pharmacy Bulk Package is a sterile dosage form which contains multiple single doses for use only in a pharmacy bulk admixture program. The content and physical characteristics of the solutions are as follows: Solution Characteristics 70% Dextrose Injection, USP pH 4.0 pH range 3.2 -
6.5Osmolarity (mOsmol/L) (calc.) 3532 Specific Gravity 1.236 Grams Dextrose/100 mL 70 kcal/100 mL Caloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous. 238 Fill volume (mL) 2000 The solutions contain no bacteriostat, antimicrobial agent or added buffer and are intended only for use as a single-dose injection following admixture or dilution. This Pharmacy Bulk Package is intended only for use in the preparation of sterile, intravenous nutrient admixtures using automated compounding devices.
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.
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.
Dextrose Structural Formula