Dextrose Monohydrate 25 g/50mL 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.
Where does this data come from?
🏭 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
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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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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.
3 inactive ingredients 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
Are inactive ingredients the same for every manufacturer?
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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 | $4.75 | $237.65 / 50 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · A4216 | No ASP payment limit on file for A4216 this quarter. | |
Where does this data come from?
🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dextrose 25 g/50mL 00404-9845-50 | Henry | 1 syringe | — | — | FDA listed | — |
| Dextrose 25 g/50mL 00409-7517-16 | Hospira, | 1 syringe | — | — | FDA listed | — |
| 50% Dextrose 25 g/50mL 51662-1216-01 | HF | 1 syringe | — | — | FDA listed | — |
| Dextrose Monohydrate 25 g/50mL 51662-1453-01 | HF | 1 syringe | — | — | Discontinued | — |
| Dextrose monohydrate 25 g/50mL 51662-1584-01 | HF | 1 syringe | — | AP | FDA listed | — |
| Dextrose 25 g/50mL 70518-4219-00 | REMEDYREPACK | 1 syringe | — | — | FDA listed | — |
| Dextrose 25 g/50mL 71872-7003-01 | Medical | 1 syringe | — | — | FDA listed | — |
| Dextrose 25 g/50mL 71872-7102-01 | Medical | 1 syringe | — | — | FDA listed | — |
| Dextrose Monohydrate 25 g/50mL 71872-7282-01 | Medical | 1 syringe | — | AP | FDA listed | — |
| Dextrose Monohydrate 25 g/50mLthis 76329-3302-01 | International | 1 syringe | — | AP | FDA listed | — |
| Dextrose 25 g/50mL 84549-0517-16 | ProPharma | 50 ml | — | — | FDA listed | — |
| Dextrose 25 g/50mL 71872-7057-01 | Medical | 1 vial | — | — | FDA listed | — |
| Dextrose 25 g/50mL 00404-9847-50 | Henry | 1 vial | — | — | FDA listed | — |
| Dextrose 25 g/50mL 00409-6648-02 | Hospira, | 25 vials | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 76329-3302-01 You're viewing this | 1 SYRINGE in 1 CARTON (76329-3302-1) / 50 mL in 1 SYRINGE | 2021-11-11 | 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 | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
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Is the NDC printed on the package the same as the 11-digit billing NDC?
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Is this package still being marketed?
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Do I need a prescription for this product?
Does this product have a billing J-code?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE 50% Dextrose Injection is indicated in the treatment of insulin hypoglycemia (hyperinsulinemia or insulin shock) to restore blood glucose levels. The solution is also indicated, after dilution, for intravenous infusion as a source of carbohydrate calories in patients whose oral intake is restricted or inadequate to maintain nutritional requirements. Slow infusion of hypertonic solutions is essential to ensure proper utilization of dextrose and avoid production of hyperglycemia.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION For peripheral vein administration: Injection of the solution should be made slowly . The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg of body weight/hour. About 95% of the dextrose is retained when infused at a rate of 0.8 g/kg/hr.
In insulin-induced hypoglycemia, intravenous injection of 10 to 25 grams of dextrose (20 to 50 mL of 50% dextrose) is usually adequate. Repeated doses and supportive treatment may be required in severe cases. 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. For central vein administration: For total parenteral nutrition 50% Dextrose Injection, USP is administered by slow intravenous infusion (a) after admixture with amino acid solutions via an indwelling catheter with the tip positioned in a large central vein, preferably the superior vena cava, or (b) after dilution with sterile water for injection. Dosage should be adjusted to meet individual patient requirements.
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. The maximum rate of dextrose administration which does not result in glycosuria is the same as cited above. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
See CONTRAINDICATIONS .
⛔ 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 50% Dextrose Injection 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 mental confusion and loss of consciousness, especially in patients with chronic uremia and those with known carbohydrate intolerance.
The intravenous administration of this solution can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. Additives may be incompatible. Consult with pharmacist if available.
When introducing additives, use aseptic technique, mix thoroughly and do not store. For peripheral vein administration: The solution 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 only after suitable dilution.
🤒 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, 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-evalutate the patient and institute appropriate corrective measures. See WARNINGS and PRECAUTIONS
🧬 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.
Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult 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 50% Dextrose Injection, USP 25 g/50 mL (0.5 g/mL) is supplied in single-dose prefilled syringes as follows: NDC No. Stock No. Container Size Needle 76329-3302-1 3302 50 mL None One shrink wrapped package containing 10 unit cartons, each containing a Luer-Jet™ Luer-Lock Prefilled Syringe.
Syringe Assembly Directions: USE ASEPTIC TECHNIQUE Do not assemble until ready to use. *CAUTION: IMPROPER ENGAGING MAY CAUSE GLASS BREAKAGE AND SUBSEQUENT INJURY. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.
Protect from freezing. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Revised 01/21 6933010E © International Medication Systems, Ltd., 2021 International Medication Systems, Ltd. South El Monte, CA 91733, USA An Amphastar Pharmaceuticals Company Printed in USA instructions
📋 Description ▾
DESCRIPTION 50% Dextrose Injection, USP is a sterile, nonpyrogenic, hypertonic solution of dextrose in water for injection for intravenous injection as a fluid and nutrient replenisher. Each mL of fluid contains 0.5 g dextrose, hydrous which delivers 3.4 kcal/gram. The solution has an osmolarity of 2.5 mOsmol/mL (calc.) and a pH of 3.2-6.5.
May contain Hydrochloric acid and/or Sodium hydroxide for pH adjustment. The solution contains no bacteriostat, antimicrobial agent or added buffer 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.
Dextrose, USP is chemically designated C 6 H 12 O 6 • H 2 O (D-glucose monohydrate), a hexose sugar freely soluble in water. Dextrose, hydrous has the following formula: Water for Injection, USP is chemically designated H 2 O. The delivery device is composed of a 50 mL glass syringe barrel with rubber stopper, and custom molded IMS injector with Luer Connector. structure