Indications and uses
Dextrose Injection (5% and 10%) 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 - B. Braun Medical Inc.
- Manufacturer
- B. Braun Medical Inc.
- Effective date
- 2026-10-21
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 18
- Source
- daily-update
- Hydrated at
- 2026-10-29 01:03:03
Label at a glance#
ProductDEXTROSE
Active ingredientDEXTROSE, UNSPECIFIED FORM
Label structure20 sections
Dosage and administration
Dextrose Injection (5% and 10%) 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. Consider using a central vein to administer hypertonic solutions with osmolarity of 900 mOsm/L or greater to avoid venous irritation [see Warnings and Precautions (5.3) ]. Avoid administering Dextrose Injection (5% and 10...
Storage and handling
How Supplied Dextrose Injection USP (5% and 10%) are clear, sterile, and nonpyrogenic solutions supplied in single-dose EXCEL ® Containers as shown in table below. It is available in the following presentations: NDC REF Size Package Configuration 5% Dextrose Injection USP (Canada DIN 01924281) 0264-7510-00 L5100 1000 mL Case of 12 0264-7510-10 L5101 500 mL Case of 24 0264-7510-20 L5102 250 mL Case of 24 10% Dextro...
Contacts and useful links#
Websitewww.fda.gov
www.fda.gov/medwatch
www.fda.gov/medwatchWebsitewww.bbraun.com
www.bbraun.com
www.bbraun.comLabel contents#
Full prescribing information#
1 INDICATIONS AND USAGE
Dextrose Injection (5% and 10%) 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.
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
Dextrose Injection (5% and 10%) 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.
- Consider using a central vein to administer hypertonic solutions with osmolarity of 900 mOsm/L or greater to avoid venous irritation [see Warnings and Precautions (5.3)].
- Avoid administering Dextrose Injection (5% and 10%) simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis. If there is only a single IV access, flush the line thoroughly with normal saline before and after blood product administration.
- Use of a final filter is recommended during administration of parenteral solutions, where possible.
- Discard the unused portion.
- Avoid use with chemotherapy agents. Consult the specific chemotherapy agent prescribing information to determine the appropriate diluent.
2.2 Important Preparation Information
Visually inspect the Dextrose Injection (5% and 10%) for particulate matter and discoloration. Do not administer Dextrose Injection (5% and 10%) if the solution is cloudy, there are precipitates, or the container is damaged.
To reduce the risk of air embolism, adhere to the following preparation instructions for Dextrose Injection (5% and 10%):
- 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.
- The use of pressure infusion is not recommended as a method to increase flow rates. However, if pressure infusion is required, ensure that any air within the bag is fully evacuated prior to initiation of infusion.
- If using a pumping device to administer Dextrose Injection (5% and 10%), turn off the pump before the container is empty.
To Open EXCEL® Containers
- Tear overwrap down at notch and remove solution container.
- Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below before preparing for administration.
- Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date.
- Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container which is suspect should not be used.
Preparation for Administration
- Remove plastic protector from sterile set port at bottom of container.
- Attach administration set. Refer to complete directions accompanying set.
Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.
To Add Medication Before Solution Administration
- Prepare medication site.
- Using syringe with 18-22 gauge needle, puncture medication port and inner diaphragm and inject.
- Squeeze and tap ports while ports are upright and mix solution and medication thoroughly.
To Add Medication During Solution Administration
- Close clamp on the set.
- Prepare medication site.
- Using syringe with 18-22 gauge needle of appropriate length (at least 5/8 inch), puncture resealable medication port and inner diaphragm and inject.
- Remove container from IV pole and/or turn to an upright position.
- Evacuate both ports by tapping and squeezing them while container is in the upright position.
- Mix solution and medication thoroughly.
- Return container to in-use position and continue administration.
2.3 Dosage Considerations
The choice of dextrose concentration, rate, and volume depends on the age, weight, clinical and metabolic conditions of the patient and concomitant therapy.
Dextrose Injection (5% and 10%) administration rate should be based on the patient’s tolerance of dextrose, especially for preterm neonates with low birth weight.
Increase the infusion rate gradually as needed; frequently monitor blood glucose concentrations to avoid hyperglycemia [see Warnings and Precautions (5.2), Use in Specific Populations (8.4)].
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 EXCEL® containers: 250 mL, 500 mL, and 1000 mL
- 10% (10 g/100 mL) (100 mg/mL) of dextrose hydrous in a clear, sterile, and nonpyrogenic solution in single-dose EXCEL® containers: 250 mL, 500 mL, and 1000 mL
4 CONTRAINDICATIONS
Dextrose Injection (5% and 10%) is contraindicated in patients with:
- Clinically significant hyperglycemia [see Warnings and Precautions (5.2)].
- Known hypersensitivity to dextrose [see Warnings and Precautions (5.3)].
5 WARNINGS AND PRECAUTIONS
5.1 Neonatal 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% and 10%) to ensure adequate glycemic control in order to avoid potential long-term adverse effects.
5.2 Hyperglycemia and Hyperosmolar Hyperglycemic State
The use of Dextrose Injection (5% and 10%) 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% and 10%). Insulin may be administered or adjusted to maintain optimal blood glucose levels during Dextrose Injection (5% and 10%) administration.
5.3 Hypersensitivity Reactions
Hypersensitivity reactions, including anaphylaxis, have been reported with Dextrose Injection (5% and 10%) administration [see Adverse Reactions (6)]. Stop administration of Dextrose Injection (5% and 10%) immediately if signs or symptoms of a hypersensitivity reaction develop. Initiate appropriate treatment as clinically indicated.
5.4 Phlebitis 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.
5.5 Hyponatremia
Dextrose Injection (5% and 10%) 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% and 10%) 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)].
5.6 Electrolyte Imbalance and Fluid Overload
Electrolyte deficits, particularly serum potassium and phosphate, may occur during prolonged use of Dextrose Injection (5% and 10%).
Depending on the administered volume and the infusion rate, Dextrose Injection (5% and 10%) can cause fluid overload, including pulmonary edema.
Avoid Dextrose Injection (5% and 10%) in patients at risk for fluid and/or solute overload. If use cannot be avoided in these patients, monitor fluid balance, electrolyte concentrations, and acid-base balance, 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.
5.7 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 clinically significant adverse reactions are 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 and Fluid Overload [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% and 10%) were identified in clinical studies 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.
7 DRUG INTERACTIONS
7.1 Effects on Glycemic Control and Electrolyte Balance
Dextrose Injection (5% and 10%) 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% and 10%) 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% and 10%) 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)].
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Dextrose Injection (5% and 10%) 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 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
Dextrose Injection (5% and 10%) 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% and 10%) 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 10%) and any potential adverse effects on the breastfed infant from Dextrose Injection (5% and 10%) or from the underlying maternal condition.
8.4 Pediatric Use
Dextrose Injection (5% and 10%) 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% and 10%) 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% and 10%) may result in increased serum osmolality and risk of intracerebral hemorrhage.
8.5 Geriatric Use
Dextrose Injection (5% and 10%) 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% and 10%) 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 infusion rate and patients should be closely monitored during Dextrose Injection (5% and 10%) treatment.
10 OVERDOSAGE
A medication error resulting in a high infusion rate of Dextrose Injection (5% and 10%) 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% and 10%) 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, 5.5)].
11 DESCRIPTION
Dextrose, USP is chemically designated D-glucose, monohydrate, (C6H12O6 • H2O), a hexose sugar freely soluble in water. It has the following structural formula and molecular weight:
Ingredient | Structural Formula | Molecular Weight |
Hydrous Dextrose USP |  | 198.17 g/mol |
Dextrose Injection USP (5% and 10%) is a clear, sterile, nonpyrogenic solution and contains no bacteriostatic or antimicrobial agents. These products are intended for intravenous administration.
Each mL of Dextrose Injection USP (5%) contains:
Hydrous Dextrose USP 50 mg, Water for Injection USP qs
pH 4.54 (3.5-6.5)
Calculated Osmolarity: 250 mOsmol/L
Calories per 100 mL: 17
Each mL of Dextrose Injection USP (10%) contains:
Hydrous Dextrose USP 100 mg; Water for Injection USP qs
pH: 4.5 (3.5-6.5)
Calculated Osmolarity: 505 mOsmol/L, hypertonic
Calories per 100 mL: 34
Dextrose is derived from corn.
Not made with natural rubber latex, PVC or DEHP.
The plastic container is made from a multilayered film developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert.
The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.
The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site [see Dosage and Administration (2.2)].
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Dextrose provides a source of carbohydrate calories and is used to supplement nutrition by providing glucose parenterally.
12.2 Pharmacodynamics
The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of dextrose have not been fully characterized.
12.3 Pharmacokinetics
Dextrose is oxidized to carbon dioxide and water.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies with dextrose to evaluate the drug’s carcinogenic potential, mutagenic potential, or effects on fertility have not been performed.
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
Dextrose Injection USP (5% and 10%) are clear, sterile, and nonpyrogenic solutions supplied in single-dose EXCEL® Containers as shown in table below.
It is available in the following presentations:
NDC | REF | Size | Package Configuration |
5% Dextrose Injection USP (Canada DIN 01924281) | |||
0264-7510-00 | L5100 | 1000 mL | Case of 12 |
0264-7510-10 | L5101 | 500 mL | Case of 24 |
0264-7510-20 | L5102 | 250 mL | Case of 24 |
10% Dextrose Injection USP (Canada DIN 01924427) | |||
0264-7520-00 | L5200 | 1000 mL | Case of 12 |
0264-7520-10 | L5201 | 500 mL | Case of 24 |
0264-7520-20 | L5202 | 250 mL | Case of 24 |
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.]. Minimize Exposure of Dextrose Injection USP (5% and 10%) to heat. Avoid excessive heat. Protect from freezing.
SPL UNCLASSIFIED SECTION
EXCEL is a registered trademark of B. Braun Medical Inc.
Rx only
B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862
In Canada, distributed by:
B. Braun of Canada, Ltd.
Scarborough, Ontario M1H 2W4
Y36-003-112 LD-498-4
PRINCIPAL DISPLAY PANEL - 1000 mL Container Label
5% Dextrose
Injection USP
REF L5100
NDC 0264-7510-00
DIN 01924281
HK 22598
1000 mL
EXCEL® CONTAINER
Each 100 mL contains: Hydrous Dextrose USP 5 g;
Water for Injection USP qs
pH: 4.4 (3.5-6.5); Calc. Osmolarity: 250 mOsmol/liter
Sterile, nonpyrogenic. Single dose container. Do not use in
series connection. For intravenous use only. Use only if
solution is clear and container and seals are intact.
WARNINGS: ELECTROLYTE-FREE DEXTROSE SOLUTIONS
SHOULD NOT BE GIVEN CONJOINTLY WITH BLOOD BECAUSE
AGGLOMERATION MAY OCCUR. Some additives may be
incompatible. Consult with pharmacist. When introducing
additives, use aseptic techniques. Mix thoroughly.
Do not store.
Recommended Storage: Room temperature (25°C). Avoid
excessive heat. Protect from freezing. See Package Insert.
Do not remove overwrap until ready for use. After removing the
overwrap, check for minute leaks by squeezing container firmly. If
leaks are found, discard solution as sterility may be impaired.
Not made with natural rubber latex, PVC or DEHP.
Rx only
EXCEL is a registered trademark of B. Braun Medical Inc.
B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862
www.bbraun.com
In Canada, distributed by:
B. Braun of Canada, Ltd.
Scarborough, Ontario M1H 2W4
Y94-003-242
LD-111-3
EXP
LOT
PRINCIPAL DISPLAY PANEL - 500 mL Container Label
5% Dextrose Injection USP
REF L5101
NDC 0264-7510-10
DIN 01924281
HK 22598
500 mL
EXCEL® CONTAINER
Each 100 mL contains: Hydrous Dextrose USP 5 g;
Water for Injection USP qs
pH: 4.4 (3.5-6.5); Calc. Osmolarity: 250 mOsmol/liter
Sterile, nonpyrogenic. Single dose container. Do not use in series
connection. For intravenous use only. Use only if solution is clear and
container and seals are intact.
WARNINGS: ELECTROLYTE-FREE DEXTROSE SOLUTIONS SHOULD NOT BE
GIVEN CONJOINTLY WITH BLOOD BECAUSE AGGLOMERATION MAY OCCUR.
Some additives may be incompatible. Consult with pharmacist. When
introducing additives, use aseptic techniques. Mix thoroughly. Do not store.
Recommended Storage: Room temperature (25°C). Avoid excessive heat.
Protect from freezing. See Package Insert.
Do not remove overwrap until ready for use. After removing the overwrap, check
for minute leaks by squeezing container firmly. If leaks are found, discard
solution as sterility may be impaired.
Not made with natural rubber latex, PVC or DEHP.
Rx only
EXCEL is a registered trademark of B. Braun Medical Inc.
B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862
www.bbraun.com
In Canada, distributed by:
B. Braun of Canada, Ltd.
Scarborough, Ontario M1H 2W4
Y94-003-240
LD-118-3
EXP
LOT
PRINCIPAL DISPLAY PANEL - 250 mL Container Label
5% Dextrose
Injection USP
REF L5102
NDC 0264-7510-20
DIN 01924281
HK 22598
250 mL
EXCEL® CONTAINER
Each 100 mL contains: Hydrous Dextrose USP 5 g;
Water for Injection USP qs
pH: 4.4 (3.5-6.5); Calc. Osmolarity: 250 mOsmol/liter
Sterile, nonpyrogenic. Single dose container. Do not use in series
connection. For intravenous use only. Use only if solution is clear
and container and seals are intact.
WARNINGS: ELECTROLYTE-FREE DEXTROSE SOLUTIONS
SHOULD NOT BE GIVEN CONJOINTLY WITH BLOOD BECAUSE
AGGLOMERATION MAY OCCUR. Some additives may be
incompatible. Consult with pharmacist. When introducing
additives, use aseptic techniques. Mix thoroughly. Do not store.
Recommended Storage: Room temperature (25°C). Avoid
excessive heat. Protect from freezing. See Package Insert.
Do not remove overwrap until ready for use. After removing the
overwrap, check for minute leaks by squeezing container firmly. If
leaks are found, discard solution as sterility may be impaired.
Not made with natural rubber latex, PVC or DEHP.
Rx only
EXCEL is a registered trademark of B. Braun Medical Inc.
B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862
www.bbraun.com
In Canada, distributed by:
B. Braun of Canada, Ltd.
Scarborough, Ontario M1H 2W4
Y94-003-238
LD-182-4
EXP
LOT
PRINCIPAL DISPLAY PANEL - 1000 mL Container Label
10% Dextrose
Injection USP
REF L5200
NDC 0264-7520-00
DIN 01924427
HK 22599
1000 mL
EXCEL® CONTAINER
Each 100 mL contains: Hydrous Dextrose USP 10 g;
Water for Injection USP qs
pH: 4.4 (3.5-6.5); Calc. Osmolarity: 505 mOsmol/liter,
hypertonic
Sterile, nonpyrogenic. Single dose container. Do not use in
series connection. For intravenous use only. Use only if
solution is clear and container and seals are intact.
WARNINGS: ELECTROLYTE-FREE DEXTROSE SOLUTIONS
SHOULD NOT BE GIVEN CONJOINTLY WITH BLOOD BECAUSE
AGGLOMERATION MAY OCCUR. Some additives may be
incompatible. Consult with pharmacist. When introducing
additives, use aseptic techniques. Mix thoroughly.
Do not store.
Recommended Storage: Room temperature (25°C). Avoid
excessive heat. Protect from freezing. See Package Insert.
Do not remove overwrap until ready for use. After removing the
overwrap, check for minute leaks by squeezing container firmly. If
leaks are found, discard solution as sterility may be impaired.
Not made with natural rubber latex, PVC or DEHP.
Rx only
EXCEL is a registered trademark of B. Braun Medical Inc.
B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862
www.bbraun.com
In Canada, distributed by:
B. Braun of Canada, Ltd.
Scarborough, Ontario M1H 2W4
Y94-003-241
LD-181-3
EXP
LOT
PRINCIPAL DISPLAY PANEL - 500 mL Container Label
10% Dextrose Injection USP
REF L5201
NDC 0264-7520-10
DIN 01924427
HK 22599
500 mL
EXCEL® CONTAINER
Each 100 mL contains: Hydrous Dextrose USP 10 g;
Water for Injection USP qs
pH: 4.4 (3.5-6.5); Calc. Osmolarity: 505 mOsmol/liter, hypertonic
Sterile, nonpyrogenic. Single dose container. Do not use in series
connection. For intravenous use only. Use only if solution is clear and
container and seals are intact.
WARNINGS: ELECTROLYTE-FREE DEXTROSE SOLUTIONS SHOULD NOT BE
GIVEN CONJOINTLY WITH BLOOD BECAUSE AGGLOMERATION MAY OCCUR.
Some additives may be incompatible. Consult with pharmacist. When
introducing additives, use aseptic techniques. Mix thoroughly. Do not store.
Recommended Storage: Room temperature (25°C). Avoid excessive heat.
Protect from freezing. See Package Insert.
Do not remove overwrap until ready for use. After removing the overwrap, check
for minute leaks by squeezing container firmly. If leaks are found, discard
solution as sterility may be impaired.
Not made with natural rubber latex, PVC or DEHP.
Rx only
EXCEL is a registered trademark of B. Braun Medical Inc.
B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862
www.bbraun.com
In Canada, distributed by:
B. Braun of Canada, Ltd.
Scarborough, Ontario M1H 2W4
Y94-003-239
LD-180-3
EXP
LOT
PRINCIPAL DISPLAY PANEL - 250 mL Container Label
10% Dextrose
Injection USP
REF L5202
NDC 0264-7520-20
DIN 01924427
HK 22599
250 mL
EXCEL® CONTAINER
Each 100 mL contains: Hydrous Dextrose USP 10 g;
Water for Injection USP qs
pH: 4.4 (3.5-6.5); Calc. Osmolarity: 505 mOsmol/liter,
hypertonic
Sterile, nonpyrogenic. Single dose container. Do not use in series
connection. For intravenous use only. Use only if solution is clear
and container and seals are intact.
WARNINGS: ELECTROLYTE-FREE DEXTROSE SOLUTIONS
SHOULD NOT BE GIVEN CONJOINTLY WITH BLOOD BECAUSE
AGGLOMERATION MAY OCCUR. Some additives may be
incompatible. Consult with pharmacist. When introducing
additives, use aseptic techniques. Mix thoroughly. Do not store.
Recommended Storage: Room temperature (25°C). Avoid excessive
heat. Protect from freezing. See Package Insert.
Do not remove overwrap until ready for use. After removing
the overwrap, check for minute leaks by squeezing container firmly. If
leaks are found, discard solution as sterility may be impaired.
Not made with natural rubber latex, PVC or DEHP.
Rx only
EXCEL is a registered trademark of B. Braun Medical Inc.
B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862
www.bbraun.com
In Canada, distributed by:
B. Braun of Canada, Ltd.
Scarborough, Ontario M1H 2W4
Y94-003-237
LD-179-3
EXP
LOT
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| 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 |
|---|---|---|---|---|---|
| 0264-7510-00 | ML - Milliliter | 0264-7510 | 7bf075e0-9418-4a31-ab20-e66c6c977214 | 1 | 2012-07-24 |
| 0264-7510-10 | ML - Milliliter | 0264-7510 | c1856193-3cb2-46f2-ba5c-afee6a11a7b3 | 1 | 2012-07-24 |
| 0264-7510-20 | ML - Milliliter | 0264-7510 | 531fbe38-a220-4619-9acb-4f4db628d06c | 1 | 2012-07-24 |
| 0264-7520-00 | ML - Milliliter | 0264-7520 | a5fb9b2d-f1d1-408f-87f6-c0dee786d5e1 | 1 | 2012-07-24 |
| 0264-7520-10 | ML - Milliliter | 0264-7520 | d97e3033-155f-435c-afe9-ef7c85fdc0ce | 1 | 2012-07-24 |
| 0264-7520-20 | ML - Milliliter | 0264-7520 | 81a2c13c-032b-416e-8904-7828d462c9c3 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DEXTROSE | ACTIVE INGREDIENT | IY9XDZ35W2 | 7 | |
| DEXTROSE | ACTIVE MOIETY | IY9XDZ35W2 | 7 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 7 |
Products#
Every source-derived product name is available through these pages.
- DEXTROSE
- DEXTROSE, UNSPECIFIED FORM
- ANHYDROUS DEXTROSE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0264-7510 | 0264-7510-00, 0264-7510-10, 0264-7510-20 |
| 0264-7520 | 0264-7520-00, 0264-7520-10, 0264-7520-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROSE, UNSPECIFIED FORM | IY9XDZ35W2 | ACTIB |
| WATER | 059QF0KO0R | IACT |
| DEXTROSE, UNSPECIFIED FORM | IY9XDZ35W2 | ACTIB |
| WATER | 059QF0KO0R | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 12 | 2024-03-12 | full-release | 2026-05-31 21:00:57 |
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 |
|---|---|---|---|---|---|---|---|
| N019626-001 | DEXTROSE 2.5% IN PLASTIC CONTAINER | DEXTROSE | 2.5GM/100ML | INJECTABLE / INJECTION | 1988-02-02 | ||
| N019626-002 | DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-02-02 |
| N019626-003 | DEXTROSE 7.7% IN PLASTIC CONTAINER | DEXTROSE | 7.7GM/100ML | INJECTABLE / INJECTION | 1988-02-02 | ||
| N019626-004 | DEXTROSE 10% IN PLASTIC CONTAINER | DEXTROSE | 10GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-02-02 |
| N019626-005 | DEXTROSE 70% IN PLASTIC CONTAINER | DEXTROSE | 70GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2015-02-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N019626-002 | AP |
| N019626-004 | AP |
| N019626-005 | 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 | N019626-001 | DEXTROSE 2.5% IN PLASTIC CONTAINER | 2.5GM/100ML | INJECTABLE / INJECTION | 1988-02-02 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N019626-002 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-02-02 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N019626-003 | DEXTROSE 7.7% IN PLASTIC CONTAINER | 7.7GM/100ML | INJECTABLE / INJECTION | 1988-02-02 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N019626-004 | DEXTROSE 10% IN PLASTIC CONTAINER | 10GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-02-02 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N019626-005 | DEXTROSE 70% IN PLASTIC CONTAINER | 70GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2015-02-18 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N019626-001 | DEXTROSE 2.5% IN PLASTIC CONTAINER | 2.5GM/100ML | INJECTABLE / INJECTION | 1988-02-02 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019626-002 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-02-02 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N019626-003 | DEXTROSE 7.7% IN PLASTIC CONTAINER | 7.7GM/100ML | INJECTABLE / INJECTION | 1988-02-02 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019626-004 | DEXTROSE 10% IN PLASTIC CONTAINER | 10GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-02-02 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N019626-005 | DEXTROSE 70% IN PLASTIC CONTAINER | 70GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2015-02-18 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N019626-001 | DEXTROSE 2.5% IN PLASTIC CONTAINER | 2.5GM/100ML | INJECTABLE / INJECTION | 1988-02-02 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019626-002 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-02-02 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019626-003 | DEXTROSE 7.7% IN PLASTIC CONTAINER | 7.7GM/100ML | INJECTABLE / INJECTION | 1988-02-02 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019626-004 | DEXTROSE 10% IN PLASTIC CONTAINER | 10GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-02-02 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019626-005 | DEXTROSE 70% IN PLASTIC CONTAINER | 70GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2015-02-18 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N019626-001 | DEXTROSE 2.5% IN PLASTIC CONTAINER | 2.5GM/100ML | INJECTABLE / INJECTION | 1988-02-02 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019626-002 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-02-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019626-003 | DEXTROSE 7.7% IN PLASTIC CONTAINER | 7.7GM/100ML | INJECTABLE / INJECTION | 1988-02-02 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019626-004 | DEXTROSE 10% IN PLASTIC CONTAINER | 10GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-02-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019626-005 | DEXTROSE 70% IN PLASTIC CONTAINER | 70GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2015-02-18 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019626-001 | DEXTROSE 2.5% IN PLASTIC CONTAINER | 2.5GM/100ML | INJECTABLE / INJECTION | 1988-02-02 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019626-002 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-02-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019626-003 | DEXTROSE 7.7% IN PLASTIC CONTAINER | 7.7GM/100ML | INJECTABLE / INJECTION | 1988-02-02 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019626-004 | DEXTROSE 10% IN PLASTIC CONTAINER | 10GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-02-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019626-005 | DEXTROSE 70% IN PLASTIC CONTAINER | 70GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2015-02-18 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019626-001 | DEXTROSE 2.5% IN PLASTIC CONTAINER | 2.5GM/100ML | INJECTABLE / INJECTION | 1988-02-02 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019626-002 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-02-02 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019626-003 | DEXTROSE 7.7% IN PLASTIC CONTAINER | 7.7GM/100ML | INJECTABLE / INJECTION | 1988-02-02 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019626-004 | DEXTROSE 10% IN PLASTIC CONTAINER | 10GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-02-02 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019626-005 | DEXTROSE 70% IN PLASTIC CONTAINER | 70GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2015-02-18 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019626-001 | DEXTROSE 2.5% IN PLASTIC CONTAINER | 2.5GM/100ML | INJECTABLE / INJECTION | 1988-02-02 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019626-002 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-02-02 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019626-003 | DEXTROSE 7.7% IN PLASTIC CONTAINER | 7.7GM/100ML | INJECTABLE / INJECTION | 1988-02-02 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019626-004 | DEXTROSE 10% IN PLASTIC CONTAINER | 10GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-02-02 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019626-005 | DEXTROSE 70% IN PLASTIC CONTAINER | 70GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2015-02-18 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019626-001 | DEXTROSE 2.5% IN PLASTIC CONTAINER | 2.5GM/100ML | INJECTABLE / INJECTION | 1988-02-02 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019626-002 | DEXTROSE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-02-02 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019626-003 | DEXTROSE 7.7% IN PLASTIC CONTAINER | 7.7GM/100ML | INJECTABLE / INJECTION | 1988-02-02 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019626-004 | DEXTROSE 10% IN PLASTIC CONTAINER | 10GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-02-02 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019626-005 | DEXTROSE 70% IN PLASTIC CONTAINER | 70GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2015-02-18 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N019626-002 | AP | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N019626-004 | AP | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N019626-005 | AP | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N019626-002 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N019626-004 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N019626-005 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N019626-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019626-004 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019626-005 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N019626-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019626-004 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019626-005 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019626-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019626-004 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019626-005 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019626-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019626-004 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019626-005 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019626-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019626-004 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019626-005 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019626-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019626-004 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019626-005 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019626-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019626-004 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019626-005 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019626-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019626-004 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019626-005 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019626-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019626-004 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019626-005 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019626-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019626-004 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019626-005 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N019626-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019626-004 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019626-005 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019626-002 | AP | 1 | 79d66fd596c7… |
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 |
|---|---|---|---|---|---|---|
| c9f87749-8dd5-41fd-b393-f63d45fd00ef | 085614c7-ada4-4e2c-87c0-c9bc2f18365a | 2024-03-12 | Warnings, Adverse reactions | 085614c7-ada4-4e2c-87c0-c9bc2f18365a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.