Indications and uses
Dextrose Injection is indicated as source of water and calories.
These highlights do not include all the information needed to use
- Manufacturer
- Baxter Healthcare Corporation | Bieffe Medital SA
- Effective date
- 2025-06-30
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 12
- Source
- weekly-update
- Hydrated at
- 2026-07-17 21:44:48
Label at a glance#
ProductDEXTROSE
Active ingredientDEXTROSE MONOHYDRATE
Label structure15 sections
Dosage and administration
• Dextrose Injection is intended for intravenous use. • Peripheral administration of 5% dextrose is generally acceptable, however, consider central vein when administering more than 5% dextrose or with an osmolarity of at least 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain [see Warnings and Precautions (5.3) ] . • Do not administer Dextrose Injection simultaneously with ...
Storage and handling
Dextrose Injection, USP are clear, colorless, sterile solutions of dextrose supplied in VIAFLO dripless access containers (DAC) and non-DAC plastic containers are shown below. VIAFLO DAC will not drip once the spike is removed. VIAFLO non-DAC will drip once the spike is removed from the administration port. Product Description Size Code NDC Dextrose Injection 5%, USP (0.05 grams/mL) 50mL (DAC) 50mL (Non-DAC) 100mL...
Contacts and useful links#
Websitewww.fda.gov
www.fda.gov/medwatch
www.fda.gov/medwatchLabel contents#
Full prescribing information#
1 INDICATIONS AND USAGE
Dextrose Injection is indicated as source of water and calories.
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
- Dextrose Injection is intended for intravenous use.
- Peripheral administration of 5% dextrose is generally acceptable, however, consider central vein when administering more than 5% dextrose or with an osmolarity of at least 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain [see Warnings and Precautions (5.3)].
- Do not administer Dextrose Injection simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis.
- To prevent air embolism, use a non-vented infusion set or close the vent on a vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administration, do not pressurize the flexible container to increase flow rates, and if administration is controlled by a pumping device, turn off pump before the container runs dry.
- 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.
- Use of a final filter is recommended during administration of parenteral solutions, where possible.
2.2 Recommended Dosage
The choice of dextrose concentration, rate and volume depends on the age, weight, clinical and metabolic conditions of the patient and concomitant therapy. Electrolyte supplementation may be indicated according to the clinical needs of the patient.
The administration rate should be governed, especially for premature infants with low birth weight, during the first few days of therapy, by the patient’s tolerance to dextrose.
Increase the infusion rate gradually as indicated by frequent monitoring of blood glucose concentrations [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].
2.3 Instructions for Use
To Open
- Do not remove from overpouch until ready to use.
- Tear overwrap down side at slit and remove solution container. Small amounts of moisture may be found on the solution container from water permeating from inside the container. The amount of permeated water is insufficient to affect the solution significantly. If larger amounts of water are found, the container should be checked for tears or leaks.
- Visually inspect the container. 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. Evaluate the following:
- If the outlet port protector is damaged, detached, or not present, discard container.
- Check to ensure the solution is clear and there are no precipitates. Discard if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals.
- Check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard container.
Preparation for Administration
- Suspend container from eyelet support.
- Remove protector from outlet port at bottom of container.
- Attach administration set. Refer to complete directions accompanying set.
To Add Medication
- Additives may be incompatible. Complete information is not available. Do not use additives known or determined to be incompatible.
- Consult with pharmacist, if available. If, in the informed judgment of the healthcare provider, it is deemed advisable to introduce additives, use aseptic technique.
- When introducing additives, consult the instructions for use of the medication to be added and other relevant literature.
- Before adding a substance or medication, verify that it is soluble and/or stable in Dextrose Injection and that the pH range of Dextrose Injection is appropriate.
To Add Medication Before Solution Administration
- Prepare medication site.
- Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
- Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.
- After addition, check to ensure the solution is clear and there are no precipitates. Discard if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals.
To Add Medication During Solution Administration
- Close clamp on the set.
- Prepare medication site.
- Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
- Remove container from IV pole and/or turn to an upright position.
- Evacuate both ports by squeezing them while container is in the upright position.
- Mix solution and medication thoroughly.
- After addition, check to ensure the solution is clear and there are no precipitates. Discard if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals, do not use.
- Return container to in-use position and continue administration.
Storage
- Use promptly; do not store solutions containing additives.
- Single-dose container.
- Discard any unused portion.
3 DOSAGE FORMS AND STRENGTHS
Dextrose Injection, USP is a clear, sterile, non-pyrogenic solution of dextrose in single-dose containers:
- 5% (0.05 grams/mL): 5 grams of dextrose hydrous per 100 mL in partial-fill flexible containers: 250 mL, 500 mL, and 1000 mL
4 CONTRAINDICATIONS
The use of Dextrose Injection is contraindicated in patients with:
- Clinically significant hyperglycemia [see Warnings and Precautions (5.1) ].
- Known hypersensitivity to dextrose [see Warnings and Precautions (5.2) ].
5 WARNINGS AND PRECAUTIONS
5.1 Hyperglycemia and Hyperosmolar Hyperglycemic State
The use of dextrose infusions 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 (5.5)]. 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. Insulin may be administered or adjusted to maintain optimal blood glucose levels during Dextrose Injection administration.
5.2 Hypersensitivity Reactions
Hypersensitivity and infusion reactions, including anaphylaxis, have been reported with Dextrose Injection [see Adverse Reactions (6)]. Stop infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated.
5.3 Vein Damage and Thrombosis
Peripheral administration of 5% Dextrose Injection is generally acceptable, however, consider central vein when administering more than 5% dextrose or with an osmolarity of ≥ at least 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain [see Dosage and Administration (2. 1)]. The infusion of hypertonic solutions into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis. The primary complication of peripheral access is venous thrombophlebitis, which manifests as pain, erythema, tenderness or a palpable cord. Remove the catheter as soon as possible, if thrombophlebitis develops.
5.4 Hyponatremia
5% Dextrose Injection is an isotonic solution [see Description, Table 1 (11)]. In the body, however, glucose containing fluids can become extremely physiologically hypotonic due to rapid glucose metabolization. Monitoring of serum sodium is particularly important for hypotonic fluids.
Depending on the tonicity of the solution, the volume and rate of infusion, and depending on a patient’s underlying clinical condition and capability to metabolize glucose, intravenous administration of glucose can cause electrolyte disturbances, most importantly hypo- or hyperosmotic hyponatremia. Monitor serum sodium to minimize the risk of hyponatremia.
The risk for hyponatremia is increased in pediatric patients, elderly patients, postoperative patients, those with psychogenic polydipsia, and in patients treated with medications that increase the risk of hyponatremia (such as diuretics, certain antiepileptic and psychotropic medications). Close clinical monitoring may be warranted.
Acute hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury. Patients at increased risk for developing complications of hyponatremia, such as hyponatremic encephalopathy include pediatric patients; women, in particular, premenopausal women; patients with hypoxemia; and in patients with underlying central nervous system disease [see Use in Specific Populations (8.4, 8.5)].
Avoid Dextrose Injection in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations.
Rapid correction of hyponatremia is potentially dangerous with risk of serious neurologic complications. Brain adaptations reducing risk of cerebral edema make the brain vulnerable to injury when chronic hyponatremia is too rapidly corrected, which is known as osmotic demyelination syndrome (ODS). To avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and signs of neurologic complications.
High volume infusion must be used with close monitoring in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital-acquired hyponatremia.
5.5 Electrolyte Imbalance and Fluid Overload
Electrolyte deficits, particularly in serum potassium and phosphate, may occur during prolonged use of concentrated dextrose solutions.
Depending on the volume and rate of infusion, the patient’s underlying clinical condition and capability to metabolize dextrose, intravenous administration of Dextrose Injection can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, (including hypoosmotic hyponatremia), overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations in the administered solution. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations in the solution.
Avoid Dextrose Injection in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor fluid balance, blood electrolyte levels, concentration of glucose, acid-base balance, correct fluid and electrolyte imbalances during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation and acid-base balance as needed and especially during prolonged use. Additional monitoring is recommended for patients with water and electrolyte disturbances that could be aggravated by increased glucose, insulin administration and/or free water load. Patients at increased risk for developing hyponatremic encephalopathy include pediatric patients; elderly patients, women, in particular premenopausal women; patients with hypoxemia; and patients with underlying CNS disease [see Use in Specific Populations (8.4, 8.5)].
5.6 Refeeding 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 intake.
6 ADVERSE REACTIONS
The following adverse reactions associated with the use of dextrose injection were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure.
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions (5.1)]
- Hypersensitivity Reactions: anaphylaxis, pruritis, bronchospasm, cyanosis, angioedema, hypotension, pyrexia, chills, and rash [see Warnings and Precautions (5.2)]
- Infusion Site Reactions: infusion site phlebitis, infusion site erythema, vein damage and thrombosis [see Warnings and Precautions (5.3)]
- Hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.4)]
- Electrolyte imbalance, fluid overload and hypervolemia [see Warnings and Precautions (5.5)]
- Refeeding syndrome [see Warnings and Precautions (5.6)]
7 DRUG INTERACTIONS
7.1 Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance
Dextrose Injection can affect glycemic control, vasopressin and fluid and/or electrolyte balance [see Warnings and Precautions (5.1, 5.4, 5.5)]. Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations and acid-base balance when using Dextrose Injection in patients treated with other substances that affect glycemic control, vasopressin or fluid and/or electrolyte balance.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Appropriate administration of Dextrose Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with injectable dextrose solutions.
The estimated background risk of major birth defects and miscarriage for the indicated population is 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.
8.2 Lactation
Risk Summary
There are no data on the presence of dextrose in human milk, the effects on a breastfed infant, or the effects on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of Dextrose Injection to an infant during lactation; therefore, 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.
8.4 Pediatric Use
The safety profile of Dextrose Injection in pediatric patients is similar to adults.
Neonates, especially premature infants 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.
Closely monitor plasma electrolyte concentrations in pediatric patients who 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 risk of intracerebral hemorrhage.
Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions (5.4)].
8.5 Geriatric Use
Clinical studies of Dextrose Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions (5.4)]. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Dextrose is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
10 OVERDOSAGE
An increased infusion rate of Dextrose Injection or administration of dextrose solutions can cause hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance [see Warnings and Precautions (5.1, 5.5)].
Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal. Discontinue infusion, reduce dose and institute appropriate corrective measures such as administration of exogenous insulin.
Discontinue infusion and institute appropriate corrective measures in the event of overhydration or solute overload during therapy, with particular attention to CNS, respiratory and cardiovascular systems.
If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.
11 DESCRIPTION
Dextrose Injection, USP is sterile, non-pyrogenic solutions of Dextrose, USP in Water for Injection in a flexible plastic container for intravenous administration as a source of water and calories.
Partial-fill containers, designed to facilitate admixture when necessary, are available in 250 mL, 500 mL, and 1000 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 intended only for use as a single-dose injection. The pH range is 4.0 (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.
| Strength | Fill Volume | Amount of Dextrose Hydrous per Container | kcal* per Container | Osmolarity (mOsmol per liter) |
|---|---|---|---|---|
Dextrose Injection 5%, USP | 50 mL | 2.5 grams | 8.5 | 252 |
100 mL | 5 grams | 17 | 252 | |
250 mL | 12.5 grams | 42.5 | 252 | |
500 mL | 25 grams | 85 | 252 | |
1000 mL | 50 grams | 170 | 252 |
* Caloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous
Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 • H2O), 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 H2O.
Dextrose is derived from corn.
VIAFLO is a flexible plastic container fabricated from a multilayer sheeting (PL-2442) composed of Polypropylene (PP), Polyamide (PA) and Polyethylene (PE). Two different administration connectors are available with VIAFLO containers. The VIAFLO dripless access container (DAC) will not drip once the spike is removed. The non-DAC VIAFLO will drip once the spike is removed from the administration port.
VIAFLO is not made with natural rubber latex, DEHP, or PVC.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Dextrose is oxidized to carbon dioxide and water, yielding energy.
16 HOW SUPPLIED/STORAGE AND HANDLING
Dextrose Injection, USP are clear, colorless, sterile solutions of dextrose supplied in VIAFLO dripless access containers (DAC) and non-DAC plastic containers are shown below. VIAFLO DAC will not drip once the spike is removed. VIAFLO non-DAC will drip once the spike is removed from the administration port.
Product Description | Size | Code | NDC |
Dextrose Injection 5%, USP | 50mL (DAC) 50mL (Non-DAC) 100mL (DAC) 100mL (Non-DAC) 250 mL (DAC) 250 mL (Non-DAC) 500 mL (DAC) 500 mL (Non-DAC) 1000 mL (DAC) 1000 mL (Non-DAC) 1000 mL (DAC) 1000 mL (Non-DAC) | UE0086DG UE0086G UE0087DG UE0087G UE0062D UE0062 UE0063D UE0063 UE0064D UE0064 UE0064DG UE0064G | 0338-9651-75 0338-9649-75 0338-9655-60 0338-9653-60 0338-0062-30 0338-0074-30 0338-0066-20 0338-0078-20 0338-0070-10 0338-0082-10 0338-0070-12 0338-0082-12 |
Do not remove container from the overwrap until intended for use.
Use the product immediately after mixing and the introduction of additives.
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F); brief exposure up to 40°C/104°F does not adversely affect the product.
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)]
- Vein damage and thrombosis [see Warnings and Precautions (5.3)]
- Hyponatremia [see Warnings and Precautions (5.4)]
- Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.5)]
- Refeeding syndrome [see Warnings and Precautions (5.6)]
SPL UNCLASSIFIED SECTION
Manufactured by, Packed by, Distributed by:
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
SA-30-03-066
Baxter and Viaflo are trademarks of Baxter International Inc.
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Container Label
Baxter
NDC 0338-9651-75
UE0086DG
50mL
Viaflo
5% Dextrose Injection USP
pH 4.0 (3.2-6.5)
Osmolarity 252 mOsmol/L (calc)
Sterile non pyrogenic
Single dose container
Each 50 mL contains 2.5 g Dextrose Hydrous USP
Read Package Leaflet for full information
Additives may be incompatible Dosage Intravenously
as directed by a physician Cautions Must not
be used in series connections Do not administer
simultaneously with blood Do not use unless solution
is clear Rx Only Store unit in moisture barrier
overwrap at room temperature (25°C/77°F) until
ready to use Avoid excessive heat See insert
VIAFLO is not made from natural rubber latex, DEHP,
or PVC
7 Symbol
Baxter and Viaflo are trademarks of Baxter
International Inc. For product information
1-800-933-0303 Baxter Healthcare Corporation
Deerfield IL 60015 USA Made in Spain
UN-35-04-151 1
Lot
Expiry
(01) 00303389651758
Carton Label
UE0086DG
75 x 50 mL
( ≈ 6 kg)
5% Dextrose Injection, USP
Formula per 50 mL
Dextrose Hydrous 2.5 g
Water for Injection
Osmolarity 252 mOsmol/L (calc)
pH 4.0 (3.5-6.5)
IV administration.
Read package insert before use.
Keep out of reach and sight of children.
Do not connect partially used drugs.
Baxter Healthcare Corporation
Deerfield IL 60015 USA
Made in Spain
Viaflo
P333E750
?? - 0001
Lot: ????????
Expiry: YYYY/MM
(01)50303389651753(17)YYMM00(10)????????
UE0086DG
75 x 50 mL
( ≈ 6 kg)
5% Dextrose
Injection, USP
Viaflo
2D Barcode
Lot:
????????
Expiry:
YYYY/MM
(01)50303389651753(17)YYMM00(10)????????
Container Label
Baxter
NDC 0338-9649-75
UE0086G
50mL
Viaflo
5% Dextrose Injection USP
pH 4.0 (3.2-6.5)
Osmolarity 252 mOsmol/L (calc)
Sterile non pyrogenic
Single dose container
Each 50 mL contains 2.5 g Dextrose Hydrous USP
Read Package Leaflet for full information
Additives may be incompatible Dosage Intravenously
as directed by a physician Cautions Must not
be used in series connections Do not administer
simultaneously with blood Do not use unless solution
is clear Rx Only Store unit in moisture barrier
overwrap at room temperature (25°C/77°F) until
ready to use Avoid excessive heat See insert
VIAFLO is not made from natural rubber latex, DEHP,
or PVC
7 Symbol
Baxter and Viaflo are trademarks of Baxter
International Inc
For product information 1-800-933-0303
Baxter Healthcare Corporation
Deerfield IL 60015 USA Made in Spain
UN-35-04-348 1
Lot
Expiry
(01)00303389649755
Carton Label
UE0086G
75 x 50 mL
( ≈ 6 kg)
5% Dextrose Injection, USP
Formula per 50 mL
Dextrose Hydrous 2.5 g
Water for Injection
Osmolarity 252 mOsmol/L (calc)
pH 4.0 (3.5-6.5)
IV administration.
Read package insert before use.
Keep out of reach and sight of children.
Do not connect partially used drugs.
Baxter Healthcare Corporation
Deerfield IL 60015 USA
Made in Spain
Viaflo
P333E746
?? - 0001
Lot: ????????
Expiry: YYYY/MM
(01)50303389649750(17)YYMM00(10)????????
UE0086G
75 x 50 mL
( ≈ 6 kg)
5% Dextrose
Injection, USP
Viaflo
2D Barcode
Lot:
????????
Expiry:
YYYY/MM
(01) 50303389649750(17)YYMM00(10)????????
Container Label
Baxter
NDC 0338-9655-60
UE0087DG
100mL
Viaflo
5% Dextrose Injection USP
pH 4.0 (3.2-6.5)
Osmolarity 252 mOsmol/L (calc)
Sterile non pyrogenic
Single dose container
Each 100 mL contains 5 g Dextrose Hydrous USP
Read Package Leaflet for full information
Additives may be incompatible Dosage Intravenously
as directed by a physician Cautions Must not
be used in series connections Do not administer
simultaneously with blood Do not use unless solution
is clear Rx Only Store unit in moisture barrier
overwrap at room temperature (25°C/77°F) until ready
to use Avoid excessive heat See insert
VIAFLO is not made from natural rubber latex, DEHP,
or PVC
7 Symbol
Baxter and Viaflo are trademarks of
Baxter International Inc
For product information 1-800-933-0303
Baxter Healthcare Corporation
Deerfield IL 60015 USA Made in Spain
UN-35-04-152 1
Lot
Expiry
(01)00303389655602
Carton Label
UE0087DG
60 x 100 mL
( ≈ 8 kg)
5% Dextrose Injection, USP
Formula per 100 mL
Dextrose Hydrous 5 g
Water for Injection
Osmolarity 252 mOsmol/L (calc)
pH 4.0 (3.5-6.5)
IV administration.
Read package insert before use.
Keep out of reach and sight of children.
Do not connect partially used drugs.
Baxter Healthcare Corporation
Deerfield IL 60015 USA
Made in Spain
Viaflo
P333E751
?? - 0001
Lot: ????????
Expiry: YYYY/MM
(01)50303389655607(17)YYMM00(10)????????
UE0087DG
60 x 100 mL
( ≈ 8 kg)
5% Dextrose
Injection, USP
Viaflo
2D Barcode
Lot:
????????
Expiry:
YYYY/MM
(01)50303389655607(17)YYMM00(10)????????
Container Label
Baxter
NDC 0338-9653-60
UE0087G
100mL
Viaflo
5% Dextrose Injection USP
pH 4.0 (3.2-6.5)
Osmolarity 252 mOsmol/L (calc)
Sterile non pyrogenic
Single dose container
Each 100 mL contains 5 g Dextrose Hydrous USP
Read Package Leaflet for full information
Additives may be incompatible Dosage Intravenously
as directed by a physician Cautions Must not
be used in series connections Do not administer
simultaneously with blood Do not use unless solution
is clear Rx Only Store unit in moisture barrier
overwrap at room temperature (25°C/77°F) until ready
to use Avoid excessive heat See insert
VIAFLO is not made from natural rubber latex, DEHP,
or PVC
7 Symbol
Baxter and Viaflo are trademarks of
Baxter International Inc
For product information 1-800-933-0303
Baxter Healthcare Corporation
Deerfield IL 60015 USA Made in Spain
UN-35-04-349 1
Lot
Expiry
(01)00303389653608
Carton Label
UE0087G
60 x 100 mL
( ≈ 8 kg)
5% Dextrose Injection, USP
Formula per 100 mL
Dextrose Hydrous 5 g
Water for Injection
Osmolarity 252 mOsmol/L (calc)
pH 4.0 (3.5-6.5)
IV administration.
Read package insert before use.
Keep out of reach and sight of children.
Do not connect partially used drugs.
Baxter Healthcare Corporation
Deerfield IL 60015 USA
Made in Spain
Viaflo
P333E747
?? - 0001
Lot: ????????
Expiry: YYYY/MM
(01)50303389653603(17)YYMM00(10)????????
UE0087G
60 x 100 mL
( ≈ 8 kg)
5% Dextrose
Injection, USP
Viaflo
2D Barcode
Lot:
????????
Expiry:
YYYY/MM
(01)50303389653603(17)YYMM00(10)????????
Baxter
Viaflo
5% Dextrose
Injection USP
UE0062D
0338-0062-30
250 mL
Sterile non pyrogenic
Single dose container
pH 4.0 (3.2-6.5)
Osmolarity 252 mOsm/L (calc)
Each 100 mL contains 5 g Dextrose Hydrous USP Additives may be incompatible
Consult with pharmacist if available when introducing additives Use aseptic
technique Mix thoroughly Do not store Dosage intravenously as directed by a
physician See directions Cautions Squeeze and inspect inner bag which maintains
product sterility Discard if leaks are found Must not be used in series connections
Do not administer simultaneously with blood Do not use unless solution is clear
Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F)
until ready to use Avoid excessive heat See insert VIAFLO is not made from natural
rubber latex, DEHP, or PVC
Baxter and Viaflo are trademarks of Baxter International Inc.
For product information
1-800-933-0303
Baxter Healthcare Corporation
Deerfield IL 60015 USA
Made in Spain
BAR CODE
Lot
UN-
Expiry
50
100
150
200
Baxter
Viaflo
5% Dextrose
Injection USP
UE0062
0338-0074-30
250 mL
Sterile non pyrogenic
Single dose container
pH 4.0 (3.2-6.5)
Osmolarity 252 mOsm/L (calc)
Each 100 mL contains 5 g Dextrose Hydrous USP Additives may be incompatible
Consult with pharmacist if available when introducing additives Use aseptic
technique Mix thoroughly Do not store Dosage intravenously as directed by a
physician See directions Cautions Squeeze and inspect inner bag which maintains
product sterility Discard if leaks are found Must not be used in series connections
Do not administer simultaneously with blood Do not use unless solution is clear
Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F)
until ready to use Avoid excessive heat See insert VIAFLO is not made from natural
rubber latex, DEHP, or PVC
Baxter and Viaflo are trademarks of Baxter International Inc.
For product information
1-800-933-0303
Baxter Healthcare Corporation
Deerfield IL 60015 USA
Made in Spain
BAR CODE
Lot
UN-
Expiry
50
100
150
200
Baxter
Viaflo
5% Dextrose
Injection USP
UE0063D
0338-0066-20
500 mL
Sterile non pyrogenic
Single dose container
pH 4.0 (3.2-6.5)
Osmolarity 252 mOsm/L (calc)
Each 100 mL contains 5 g Dextrose Hydrous USP Additives may be incompatible
Consult with pharmacist if available when introducing additives Use aseptic
technique Mix thoroughly Do not store Dosage intravenously as directed by a
physician See directions Cautions Squeeze and inspect inner bag which maintains
product sterility Discard if leaks are found Must not be used in series connections
Do not administer simultaneously with blood Do not use unless solution is clear
Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F)
until ready to use Avoid excessive heat See insert VIAFLO is not made from natural
rubber latex, DEHP, or PVC
Baxter and Viaflo are trademarks of Baxter International Inc.
For product information
1-800-933-0303
Baxter Healthcare Corporation
Deerfield IL 60015 USA
Made in Spain
BAR CODE
Lot
UN-35-03-406
Expiry
50
100
150
200
250
300
350
400
450
Baxter
Viaflo
5% Dextrose
Injection USP
UE0063
0338-0078-20
500 mL
Sterile non pyrogenic
Single dose container
pH 4.0 (3.2-6.5)
Osmolarity 252 mOsm/L (calc)
Each 100 mL contains 5 g Dextrose Hydrous USP Additives may be incompatible
Consult with pharmacist if available when introducing additives Use aseptic
technique Mix thoroughly Do not store Dosage intravenously as directed by a
physician See directions Cautions Squeeze and inspect inner bag which maintains
product sterility Discard if leaks are found Must not be used in series connections
Do not administer simultaneously with blood Do not use unless solution is clear Rx
Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F) until
ready to use Avoid excessive heat See insert VIAFLO is not made from natural
rubber latex, DEHP, or PVC
Baxter and Viaflo are trademarks of Baxter International Inc.
For product information
1-800-933-0303
Baxter Healthcare Corporation
Deerfield IL 60015 USA
Made in Spain
BAR CODE
Lot
UN-35-03-405
Expiry
50
100
150
200
250
300
350
400
450
Baxter
Viaflo
5% Dextrose
Injection USP
UE0064D
0338-0070-10
1000 mL
Sterile non pyrogenic
Single dose container
pH 4.0 (3.2-6.5)
Osmolarity 252 mOsm/L (calc)
Each 100 mL contains 5 g Dextrose Hydrous USP Additives may be incompatible
Consult with pharmacist if available when introducing additives Use aseptic
technique Mix thoroughly Do not store Dosage intravenously as directed by a
physician See directions Cautions Squeeze and inspect inner bag which maintains
product sterility Discard if leaks are found Must not be used in series connections
Do not administer simultaneously with blood Do not use unless solution is clear
Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F)
until ready to use Avoid excessive heat See insert VIAFLO is not made from natural
rubber latex, DEHP, or PVC
Baxter and Viaflo are trademarks of Baxter International Inc.
For product information
1-800-933-0303
Baxter Healthcare Corporation
Deerfield IL 60015 USA
Made in Spain
BAR CODE
Lot
UN-
Expiry
100
200
300
400
500
600
700
800
900
Baxter
Viaflo
5% Dextrose
Injection USP
UE0064
0338-0082-10
1000 mL
Sterile non pyrogenic
Single dose container
pH 4.0 (3.2-6.5)
Osmolarity 252 mOsm/L (calc)
Each 100 mL contains 5 g Dextrose Hydrous USP Additives may be incompatible
Consult with pharmacist if available when introducing additives Use aseptic
technique Mix thoroughly Do not store Dosage intravenously as directed by a
physician See directions Cautions Squeeze and inspect inner bag which maintains
product sterility Discard if leaks are found Must not be used in series connections
Do not administer simultaneously with blood Do not use unless solution is clear
Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F)
until ready to use Avoid excessive heat See insert VIAFLO is not made from natural
rubber latex, DEHP, or PVC
Baxter and Viaflo are trademarks of Baxter International Inc.
For product information
1-800-933-0303
Baxter Healthcare Corporation
Deerfield IL 60015 USA
Made in Spain
BAR CODE
Lot
UN-
Expiry
100
200
300
400
500
600
700
800
900
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | Code 128 | (01)50303389649750(17)YYMM00(10)???????? | GTIN-14: 50303389649750 GTIN storage (14 digits): 50303389649750 | image-05.jpg |
| Barcode | Code 128 | (01)50303389651753(17)YYMM00(10)???????? | GTIN-14: 50303389651753 GTIN storage (14 digits): 50303389651753 | image-03.jpg |
| Barcode | Code 128 | (01)50303389653603(17)YYMM00(10)???????? | GTIN-14: 50303389653603 GTIN storage (14 digits): 50303389653603 | image-09.jpg |
| Barcode | Code 128 | (01)50303389655607(17)YYMM00(10)???????? | GTIN-14: 50303389655607 GTIN storage (14 digits): 50303389655607 | image-07.jpg |
| Data code | Data Matrix | 015030338964975017YYMM0010???????? | image-05.jpg | |
| Data code | Data Matrix | 015030338965175317YYMM0010???????? | image-03.jpg | |
| Data code | Data Matrix | 015030338965360317YYMM0010???????? | image-09.jpg | |
| Data code | Data Matrix | 015030338965560717YYMM0010???????? | image-07.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| cb89b86a-369e-4204-8910-ae797c503af3 | Product name | 1 | 20230706 |
| d4880ace-a516-8c47-8dfd-73a4ba5887d7 | Product name | 2 | 20180830 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| ed912195-5da0-0f2f-6f4b-3ef17710cbe3 | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0338-9649-75 | ML - Milliliter | 0338-9649 | 159a1b51-af1f-4d9e-9a28-745ee0c29f4a | 1 | 2025-05-14 |
| 0338-9653-60 | ML - Milliliter | 0338-9653 | 03f1d730-640c-4a5a-802f-d82e0e2f91c3 | 1 | 2025-05-14 |
| 0338-0078-20 | ML - Milliliter | 0338-0078 | a7c4fbce-41ba-4da2-9773-46cde941bfc3 | 1 | 2026-05-22 |
| 0338-0062-30 | ML - Milliliter | 0338-0062 | ebf7a41d-0c8b-4234-8274-d7b1dda78c3e | 1 | 2019-07-02 |
| 0338-0074-30 | ML - Milliliter | 0338-0074 | 616c9b9d-fb08-4bee-8fe7-3b9be4892ccf | 1 | 2026-05-22 |
| 0338-0066-20 | ML - Milliliter | 0338-0066 | c123a8ee-e14b-4b3f-82f3-1ddd667c0ab8 | 1 | 2019-07-02 |
| 0338-0070-10 | ML - Milliliter | 0338-0070 | f75c61b6-0703-4eae-a36e-8ab6d35ddc42 | 1 | 2021-04-08 |
Products#
Every source-derived product name is available through these pages.
- DEXTROSE
- dextrose monohydrate
- ANHYDROUS DEXTROSE
NDC Codes#
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROSE MONOHYDRATE | LX22YL083G | ACTIB |
| DEXTROSE MONOHYDRATE | LX22YL083G | ACTIB |
| DEXTROSE MONOHYDRATE | LX22YL083G | ACTIB |
| DEXTROSE MONOHYDRATE | LX22YL083G | ACTIB |
| DEXTROSE MONOHYDRATE | LX22YL083G | ACTIB |
| DEXTROSE MONOHYDRATE | LX22YL083G | ACTIB |
| DEXTROSE MONOHYDRATE | LX22YL083G | ACTIB |
| DEXTROSE MONOHYDRATE | LX22YL083G | ACTIB |
| DEXTROSE MONOHYDRATE | LX22YL083G | ACTIB |
| DEXTROSE MONOHYDRATE | LX22YL083G | ACTIB |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 11 | 2024-08-09 | daily-update | 2026-06-12 05:10:32 |
| 10 | 2024-08-09 | full-release | 2026-05-31 21:33:20 |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N016673-001 | DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N016673-003 | DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-10-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N016673-001 | AP |
| N016673-003 | AP |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N016673-001 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N016673-003 | DEXTROSE 5% IN PLASTIC CONTAINER | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-10-30 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N016673-001 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N016673-003 | DEXTROSE 5% IN PLASTIC CONTAINER | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-10-30 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N016673-001 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N016673-003 | DEXTROSE 5% IN PLASTIC CONTAINER | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-10-30 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N016673-001 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N016673-003 | DEXTROSE 5% IN PLASTIC CONTAINER | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-10-30 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016673-001 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016673-003 | DEXTROSE 5% IN PLASTIC CONTAINER | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-10-30 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N016673-001 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N016673-003 | DEXTROSE 5% IN PLASTIC CONTAINER | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-10-30 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016673-001 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016673-003 | DEXTROSE 5% IN PLASTIC CONTAINER | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-10-30 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016673-001 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016673-003 | DEXTROSE 5% IN PLASTIC CONTAINER | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-10-30 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N016673-001 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N016673-003 | DEXTROSE 5% IN PLASTIC CONTAINER | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-10-30 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N016673-001 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N016673-003 | DEXTROSE 5% IN PLASTIC CONTAINER | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-10-30 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N016673-001 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N016673-003 | DEXTROSE 5% IN PLASTIC CONTAINER | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-10-30 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N016673-001 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N016673-003 | DEXTROSE 5% IN PLASTIC CONTAINER | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-10-30 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N016673-001 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N016673-003 | DEXTROSE 5% IN PLASTIC CONTAINER | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-10-30 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N016673-001 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N016673-003 | DEXTROSE 5% IN PLASTIC CONTAINER | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-10-30 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N016673-001 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N016673-003 | DEXTROSE 5% IN PLASTIC CONTAINER | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-10-30 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N016673-001 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N016673-003 | DEXTROSE 5% IN PLASTIC CONTAINER | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-10-30 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N016673-001 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N016673-003 | DEXTROSE 5% IN PLASTIC CONTAINER | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-10-30 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N016673-001 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N016673-003 | DEXTROSE 5% IN PLASTIC CONTAINER | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-10-30 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N016673-001 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N016673-003 | DEXTROSE 5% IN PLASTIC CONTAINER | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-10-30 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N016673-001 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N016673-003 | DEXTROSE 5% IN PLASTIC CONTAINER | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-10-30 | 4b0b4de00fa7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N016673-001 | AP | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N016673-003 | AP | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N016673-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N016673-003 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N016673-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N016673-003 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N016673-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N016673-003 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016673-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016673-003 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N016673-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N016673-003 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016673-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016673-003 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016673-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016673-003 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N016673-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N016673-003 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N016673-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N016673-003 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N016673-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N016673-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N016673-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N016673-003 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N016673-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N016673-003 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N016673-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N016673-003 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N016673-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N016673-003 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N016673-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N016673-003 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N016673-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N016673-003 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N016673-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N016673-003 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N016673-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N016673-003 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N016673-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N016673-003 | AP | 1 | 4b0b4de00fa7… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| DEXTROSE | DEXTROSE MONOHYDRATE | Baxter Healthcare Corporation | 36e9478c-5df0-4b47-b97d-de3626d7cb29 | 2025-06-30 | Warnings, Adverse reactions | 0338-0070-12 0338-0070-10 0338-0082-10 0338-9655-60 0338-0078-20 0338-9653-60 0338-0082-12 0338-0066-20 0338-0062-30 0338-9649-75 0338-0074-30 0338-9651-75 0338-9655 0338-9653 0338-0074 0338-0078 0338-9649 0338-0070 0338-0062 0338-9651 0338-0066 0338-0082 00338007820 00338008210 00338007430 00338006230 00338007012 00338006620 00338007010 00338964975 00338008212 00338965560 00338965360 00338965175 b28d6bb9-8496-48bd-b6aa-f67996d0829c 36e9478c-5df0-4b47-b97d-de3626d7cb29 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.