Dextrose 50 mg/mL Injection, Solution
Other active recalls for Dextrose Monohydrate (different manufacturers) — 3 · tap to view
Past resolved recalls for this product (1)
🆔 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
Supplement & herbal interactions
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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.
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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 · Q2 2026 | $0.0214 | $107.00 / 5000 ml |
| Medicare Part B allowsASP · J7060 | $1.649 / J7060 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dextrose 50 mg/mL 65219-0464-50 | FRESENIUS | 100 ml | — | AP | FDA listed | — |
| Dextrose 50 mg/mL 63323-0624-10 | Fresenius | 1000 ml | — | AP | FDA listed | — |
| Dextrose 50 mg/mLthis 00409-7100-67 | Hospira, | 10 pouches | — | AP | FDA listed | — |
| Dextrose 50 mg/mL 84549-0460-20 | ProPharma | 500 ml | — | AP | FDA listed | — |
| Dextrose 50 mg/mL 65219-0456-60 | FRESENIUS | 50 ml | — | AP | FDA listed | — |
| Dextrose 50 mg/mL 65219-0460-20 | FRESENIUS | 500 ml | — | AP | FDA listed | — |
| Dextrose 50 mg/mL 65219-0458-30 | FRESENIUS | 250 ml | — | AP | FDA listed | — |
| Dextrose 50 mg/mL 65219-0462-10 | FRESENIUS | 1000 ml | — | AP | FDA listed | — |
| Dextrose 50 mg/mL 17271-0720-02 | Becton | 50 ml | — | AP | 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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💊 Medicaid utilization by pack size
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00409-7100-02 | 12 POUCH in 1 CASE (0409-7100-02) / 2 BAG in 1 POUCH / 250 mL in 1 BAG (0409-7100-04) | 2005-06-27 | Active |
| 00409-7100-66 | 10 POUCH in 1 CASE (0409-7100-66) / 5 BAG in 1 POUCH / 50 mL in 1 BAG (0409-7100-68) | 2005-08-04 | Discontinued by firm |
| 00409-7100-67 You're viewing this | 10 POUCH in 1 CASE (0409-7100-67) / 5 BAG in 1 POUCH / 100 mL in 1 BAG (0409-7100-69) | 2005-09-14 | Active |
Pack size FAQ
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🧭 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) | — 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 (5%) is indicated as a source of water and calories in adult and pediatric patients and may also be used as a diluent for reconstitution of a powder or liquid drug product. Dextrose Injection (5%) is indicated as a source of water and calories in adult and pediatric patients and may also be used as a diluent for reconstitution of a powder or liquid drug product. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • Only for intravenous infusion. ( 2.1 ) • Infusion rate depends on the age, weight, clinical, and metabolic conditions of the patient and concomitant therapy. See full prescribing information for more information on preparation, administration, and dosing considerations. ( 2.1 , 2.2 , 2.3 )
2.1Important Administration Instructions Dextrose Injection (5%) is intended for intravenous use. • Use a peripheral vein to administer if the final dextrose concentration is 5% or less and the osmolarity is less than 900 mOsm/L. • To avoid venous irritation, consider using a central vein to administer hypertonic solutions with osmolarity of 900 mOsm/L or greater [see Warnings and Precautions (5.4) ] . • Do not administer Dextrose Injection (5%) simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis. • Use of a final filter is recommended during administration of parenteral solutions, where possible. • Discard the unused portion. • Do not use the Dextrose Injection (5%) ADD-Vantage TM diluent containers with chemotherapy agents.
2.2Important Preparation Information Visually inspect the Dextrose Injection (5%) for particulate matter and discoloration. Do not administer Dextrose Injection (5%) if the solution is cloudy, there are precipitates, and the container is damaged. To reduce the risk of air embolism, adhere to the following preparation instructions for Dextrose Injection (5%): • Use a non-vented infusion set or close the vent on a vented set. • Use a dedicated line without any connections (do not connect flexible containers in series). • Do not pressurize the flexible container to increase flow rates. • If using a pumping device to administer Dextrose Injection (5%), turn off the pump before the container is empty.
To Open : • Peel overwrap at corner and remove solution container. o Use unit within 30 days of opening overwrap, as long as the use date does not exceed the printed expiration date. • Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.
To Assemble Vial and Flexible Diluent Container : 1. Remove the protective covers from the top of the vial and the vial port on the diluent container as follows: a. To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (SEE FIGURE 1.), then pull straight up to remove the cap.
(SEE FIGURE 2.) NOTE: Once the breakaway cap has been removed, do not access the vial with the syringe. b. To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover. (SEE FIGURE 3.) 2.
Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately 1/2 turn (180°) after the first audible click.
(SEE FIGURE 4.) The clicking sound does not assure a seal; the vial must be turned as far as it will go. NOTE: Once vial is seated, do not attempt to remove. (SEE FIGURE 4.) 3.
Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly. 4. Label appropriately.
To Reconstitute the Drug : 1. Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial. 2.
With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container. (SEE FIGURE 5.) 3.
Pull the inner cap from the drug vial. (SEE FIGURE 6.) Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix. 4.
Mix container contents thoroughly and use within the specified time. 5. Look through the bottom of the vial to verify that the stopper has been removed…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: • 5% (5 g/100 mL) (50 mg/mL) of dextrose hydrous in a clear, sterile, and nonpyrogenic solution in single-dose flexible plastic ADD-Vantage TM diluent containers: 50 mL, 100 mL and 250 mL. This dextrose product is intended to be used as a diluent for the contents of an ADD- Vantage vial or a single-dose powdered drug vial with 20 mm closure using the ADD-Vantage ADDAPTOR TM . Injection: • 5% (5 g/100 mL) (50 mg/mL) of dextrose hydrous in single-dose flexible plastic ADD-Vantage TM diluent containers: 50 mL, 100 mL and 250 mL.
This dextrose product is intended to be used as a diluent for the contents of an ADD-Vantage vial or a single-dose powdered drug vial with 20 mm closure using the ADD-Vantage ADDAPTOR TM . ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Dextrose Injection (5%) is contraindicated in patients with: • Clinically significant hyperglycemia [see Warnings and Precautions (5.2) ] . • Known hypersensitivity to dextrose [see Warnings and Precautions (5.3) ] . • Clinically significant hyperglycemia. ( 4 ) • Known hypersensitivity to dextrose. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Neonatal Hypoglycemia : Closely monitor blood glucose concentration to ensure adequate glycemic control. ( 5.1 ) • Hyperglycemia and Hyperosmolar Hyperglycemic State : Use with caution in patients with known subclinical or overt diabetes mellitus. ( 5.2 ) • Hypersensitivity Reactions : Monitor for signs and symptoms and discontinue infusion immediately if reaction occurs.
( 5.3 ) • Phlebitis and Thrombosis : Remove catheter as soon as possible if thrombophlebitis develops. ( 2.1 , 5.4 ) • Hyponatremia : Monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and neurologic status. ( 5.5 ) • Electrolyte Imbalance and Fluid Overload : Monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during administration.
( 5.6 ) • Refeeding Syndrome : Monitory laboratory parameters. ( 5.7 )
5.1Neonatal Hypoglycemia Neonates, especially preterm neonates with low birth weight, are at increased risk of developing hypoglycemia. Closely monitor blood glucose concentration during treatment with Dextrose Injection (5%) to ensure adequate glycemic control in order to avoid potential long-term adverse effects.
5.2Hyperglycemia and Hyperosmolar Hyperglycemic State The use of Dextrose Injection (5%) in patients with 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. Hyperglycemia is associated with an increase in serum osmolality, resulting in osmotic diuresis, dehydration, and electrolyte losses [see Warnings and Precautions (5.6) , Use in Specific Populations (8.4) ] .
Patients with underlying CNS disease 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 levels within normal limits while administering Dextrose Injection (5%). Insulin may be administered or adjusted to maintain optimal blood glucose levels during Dextrose Injection (5%) administration.
5.3Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, have been reported with Dextrose Injection (5%) administration [see Adverse Reactions (6) ] . Stop administration of Dextrose Injection (5%) immediately if signs or symptoms of a hypersensitivity reaction develop. Initiate appropriate treatment as clinically indicated.
5.4Phlebitis and Thrombosis The infusion of hypertonic solutions into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis [see Dosage and Administration (2.1) ] . If thrombophlebitis develops, remove the catheter as soon as possible.
5.5Hyponatremia Dextrose Injection (5%) may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy, and vomiting. The risk of hospital-acquired hyponatremia is increased in younger pediatric patients, geriatric patients, patients treated with diuretics, and patients with cardiac or pulmonary failure or with the syndrome of inappropriate antidiuretic hormone (SIADH) (e.g., postoperative patients, patients concomitantly treated with arginine vasopressin analogs or certain antiepileptic, psychotropic, and cytotoxic drugs) [see Drug Interactions (7.1) , Use in Specific Populations (8.4) ] .
Avoid Dextrose Injection (5%) in patients with or at risk for hyponatremia. If use cannot be avoided, closely monitor serum sodium concentrations, chloride concentrations, fluid status, acid-base balance, and neurologic status [see Warnings and Precautions (5.6) ] .
5.6Electrolyte Imbalance and Fluid Overload Electrolyte deficits, particularly serum potassium and phosphate, may occur during prolonged use of Dextrose Injection (5%). Depending on the administered volume and the infusion rate, Dextrose Injection (5%) can cause fluid overload, including pulmonary edema. Avoid Dextrose Injection (5%…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are also described elsewhere in the labeling: • Neonatal Hypoglycemia [see Warnings and Precautions (5.1) ] • Hyperglycemia and Hyperosmolar Hyperglycemic State [see Warnings and Precautions (5.2) ] • Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] • Phlebitis and Thrombosis [see Warnings and Precautions (5.4) ] • Hyponatremia [see Warnings and Precautions (5.5) ] • Electrolyte Imbalance, Fluid Overload and Hypervolemia [see Warnings and Precautions (5.6) ] • Refeeding Syndrome [see Warnings and Precautions (5.7) ] The following adverse reactions associated with the use of Dextrose Injection (5%) were identified in clinical trials or postmarketing reports.
Because some of these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Administration site conditions: blister, erythema, extravasation, pain, phlebitis, vein damage, thrombosis Immune system disorders: anaphylaxis, angioedema, bronchospasm, chills, hypotension, pruritus, pyrexia, rash Cardiovascular disorders: cyanosis, volume overload The most common adverse reactions are hyperglycemia, hypersensitivity reactions, hyponatremia, infection (both systemic and at the injection site), vein thrombosis, phlebitis, and electrolyte imbalance.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Effects on Glycemic Control and Electrolyte Balance: Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations, and acid-base balance. Avoid use of Dextrose Injection in patients receiving drugs associated with hyponatremia. ( 7.1 )
7.1Drugs with Effects on Glycemic Control and Electrolyte Balance Dextrose Injection (5%) can affect glycemic control, vasopressin, and fluid and/or electrolyte balance [see Warnings and Precautions ( 5.1 , 5.2 , 5.5 , 5.6 )] . Monitor patients’ blood glucose concentrations, fluid balance, serum electrolyte concentrations, and acid-base balance. Concomitant administration of Dextrose Injection (5%) with drugs associated with hyponatremia may increase the risk of developing hyponatremia.
Drugs associated with hyponatremia include diuretics and those that cause SIADH (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), arginine vasopressin analogs, certain antiepileptic, psychotropic, and cytotoxic drugs). Avoid use of Dextrose Injection (5%) in patients receiving drugs associated with hyponatremia. If use cannot be avoided, closely monitor serum sodium concentrations during concomitant use [see Warnings and Precautions (5.5) ].
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pediatric Use: Increased risk of hypoglycemia/hyperglycemia and imbalances in fluid/electrolytes; monitor serum glucose concentrations, volume status, and electrolytes. ( 8.4 )
8.1Pregnancy Risk Summary Dextrose Injection (5%) has been used for decades during labor and delivery. Although there are a few case reports that describe adverse effects of dextrose use in other stages of pregnancy, exposure during pregnancy in general is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with dextrose.
The background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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.
8.2Lactation Risk Summary Dextrose Injection (5%) has been used for decades and is not expected to cause harm to a breastfed infant. There are no data on the effects of Dextrose Injection (5%) on levels of glucose in human milk, on the breastfed infant, or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Dextrose Injection (5%) and any potential adverse effects on the breastfed infant from Dextrose Injection (5%) or from the underlying maternal condition.
8.4Pediatric Use Dextrose Injection (5%) is indicated in pediatric patients as a source of water and calories, and may also be used as a diluent for reconstitution of a powder or liquid drug product. Neonates, especially preterm neonates with low birth weight, are at increased risk of developing hypo- or hyperglycemia. Therefore, they need close monitoring during treatment with intravenous glucose infusions to ensure adequate glycemic control in order to avoid potential long-term adverse effects.
Dextrose Injection (5%) can cause imbalances in fluid and electrolytes in pediatric patients and requires close monitoring of volume status and plasma electrolyte concentrations, particularly in pediatric patients who may have impaired ability to regulate fluids and electrolytes. Pediatric patients are at increased risk for developing hyponatremic encephalopathy [see Warnings and Precautions (5.5 , 5.6) ] . In very low birth weight neonates, excessive or rapid administration of Dextrose Injection (5%) may increase the risk of intracerebral hemorrhage.
8.5Geriatric Use Dextrose Injection (5%) has not been studied in sufficient number of patients aged 65 and over to determine whether they respond differently from younger patients. Geriatric patients are at increased risk of developing hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.5) ] . Other reported clinical experience has not identified differences in responses between the geriatric and younger adult patients.
In general, the infusion rate for geriatric patients should start slow and be titrated up cautiously, reflecting their greater risk for electrolyte abnormalities and fluid overload. Dextrose is known to be substantially excreted by the kidney, and the risk of adverse reactions to Dextrose Injection (5%) may be greater in patients with impaired renal function. Because geriatric patients are more likely to have impaired renal function, care should be taken in selection of the infusion rate, and patients should be closely monitored during Dextrose Injection (5%) treatment.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Dextrose Injection (5%) has been used for decades during labor and delivery. Although there are a few case reports that describe adverse effects of dextrose use in other stages of pregnancy, exposure during pregnancy in general is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with dextrose.
The background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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.
🧒 Pediatric Use ▾
8.4Pediatric Use Dextrose Injection (5%) is indicated in pediatric patients as a source of water and calories, and may also be used as a diluent for reconstitution of a powder or liquid drug product. Neonates, especially preterm neonates with low birth weight, are at increased risk of developing hypo- or hyperglycemia. Therefore, they need close monitoring during treatment with intravenous glucose infusions to ensure adequate glycemic control in order to avoid potential long-term adverse effects.
Dextrose Injection (5%) can cause imbalances in fluid and electrolytes in pediatric patients and requires close monitoring of volume status and plasma electrolyte concentrations, particularly in pediatric patients who may have impaired ability to regulate fluids and electrolytes. Pediatric patients are at increased risk for developing hyponatremic encephalopathy [see Warnings and Precautions (5.5 , 5.6) ] . In very low birth weight neonates, excessive or rapid administration of Dextrose Injection (5%) may increase the risk of intracerebral hemorrhage.
🧓 Geriatric Use ▾
8.5Geriatric Use Dextrose Injection (5%) has not been studied in sufficient number of patients aged 65 and over to determine whether they respond differently from younger patients. Geriatric patients are at increased risk of developing hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.5) ] . Other reported clinical experience has not identified differences in responses between the geriatric and younger adult patients.
In general, the infusion rate for geriatric patients should start slow and be titrated up cautiously, reflecting their greater risk for electrolyte abnormalities and fluid overload. Dextrose is known to be substantially excreted by the kidney, and the risk of adverse reactions to Dextrose Injection (5%) may be greater in patients with impaired renal function. Because geriatric patients are more likely to have impaired renal function, care should be taken in selection of the infusion rate, and patients should be closely monitored during Dextrose Injection (5%) treatment.
🆘 Overdosage ▾
10 OVERDOSAGE A medication error resulting in a high infusion rate of Dextrose Injection (5%) can cause hyperglycemia, hyperosmolality, and adverse effects on fluid and electrolyte balance [see Warnings and Precautions (5.2 , 5.6 )] . Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal. In the event of overdosage (overhydration or solute overload) during Dextrose Injection (5%) treatment, discontinue the infusion.
Institute corrective measures such as administration of exogenous insulin, and treat adverse effects on the CNS, respiratory, and cardiovascular systems [see Warnings and Precautions (5.2 , 5.6 )] .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Dextrose provides a source of carbohydrate calories and is used to supplement nutrition by providing glucose parenterally.
12.2Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of dextrose have not been fully characterized.
12.3Pharmacokinetics Dextrose is oxidized to carbon dioxide and water.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Dextrose provides a source of carbohydrate calories and is used to supplement nutrition by providing glucose parenterally.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Dextrose Injection, USP (5%) is a clear, colorless, sterile solution of dextrose supplied in single-dose flexible plastic ADD-Vantage TM diluent containers. This dosage form is intended to be used as a diluent for the contents of an ADD-Vantage vial or a single-dose powdered drug vial with a 20 mm closure using the ADD-Vantage ADDAPTOR TM . Unit of Sale Strength Volume NDC 0409-7100-66 Case of 50 – 50 mL bags 5% (2.5 g/50 mL) (50 mg/mL) 50 mL bags NDC 0409-7100-67 Case of 50 – 100 mL bags 5% (5 g/100 mL) (50 mg/mL) 100 mL bags NDC 0409-7100-02 Case of 24 – 250 mL bags 5% (12.5 g/250 mL) (50 mg/mL) 250 mL bags Do not remove the container from the overwrap until intended for use.
Use the product immediately after the introduction of additives. Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Do not freeze.
To contact Pfizer’s Medical Information Department, please visit www.pfizermedinfo.com or call 1‑800-438‑1985. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1143-4.0 Hospira logo
📋 Description ▾
11 DESCRIPTION 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: Water for Injection, USP is chemically designated H 2 O.
Dextrose Injection, USP (5%) is a clear, sterile, non-pyrogenic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after admixture with a single-dose powdered or liquid (up to 10 mL) drug vial [see Dosage and Administration (2.1) ] . Partial-fill containers, designed to facilitate admixture, are available in 50 mL, 100 mL, and 250 mL sizes. See Table 1 for the content and characteristics of this solution.
The solution contains no bacteriostatic, antimicrobial agent or added buffer and is supplied as single-dose containers. The pH is 4.3 (range is 3.2 to 6.5). Table 1.
Contents and Characteristics of 5% Dextrose Injections, USP 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 5% Dextrose Injection, USP (50 mg/mL) 50 mL 2.5 grams 8.5 253 100 mL 5 grams 17 253 250 mL 12.5 grams 42.5 253 Dextrose is derived from corn. 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. structural formula dextrose