Dextrose And Sodium Chloride - B. Braun Medical Inc.

Manufacturer: B. Braun Medical Inc.
Effective date: 2026-09-28
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 20
Source: daily-update
Hydrated at: 2026-10-15 01:04:12

Label at a glance#

ProductDextrose And Sodium Chloride

Active ingredientDEXTROSE, UNSPECIFIED FORM, SODIUM CHLORIDE

Label structure29 sections

Indications and uses

Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes, and calories in adults and pediatric patients.

Dosage and administration

Dextrose and Sodium Chloride Injection 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 (5.8)] . Avoid administering Dextrose and Sodium Chl...

Storage and handling

How Supplied Dextrose and Sodium Chloride Injections, USP are clear, sterile, and nonpyrogenic solutions supplied in EXCEL ® flexible containers as shown in the table below. REF / Canada DIN Size (mL) NDC Product Name Package Configuration L6080-00 / DIN 01927981 1000 0264-7608-00 3.3% Dextrose and 0.3% Sodium Chloride Injection USP Case of 12 L6081-00 / DIN 01927981 500 0264-7608-10 Case of 24 L6...

Contacts and useful links#

PhoneLabel contact1-833-425-1464

PhoneFDA MedWatch1-800-FDA-1088

PhoneLabel contact250 500 1000

PhoneLabel contact1-800-227-2862

Websitewww.fda.gov

www.fda.gov/medwatch

Label contents#

Full prescribing information#

RECENT MAJOR CHANGES SECTION

Dosage and Administration (2.1, 2.2, 2.3) 06/2026
Contraindications (4) 06/2026
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7) 06/2026

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes, and calories in adults and pediatric patients.

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

2.1 Important Administration Instructions

SPL UNCLASSIFIED SECTION

Dextrose and Sodium Chloride Injection 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 (5.8)].
Avoid administering Dextrose and Sodium Chloride Injection 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.

2.2 Important Preparation Information

SPL UNCLASSIFIED SECTION

Visually inspect the Dextrose and Sodium Chloride Injection for particulate matter and discoloration. Do not administer Dextrose and Sodium Chloride Injection 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 and Sodium Chloride Injection:

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 and Sodium Chloride Injection, turn off the pump before the container is empty.

To Open EXCEL^® Containers

Do not remove container from overwrap until ready to use.
Tear overwrap down side at slit and remove solution container.
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 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 the set.

To Add Medication

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 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 18 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 with administration.

2.3 Recommended Dosage

INSTRUCTIONS FOR USE SECTION

The choice of the specific, sodium chloride, and dextrose concentrations, 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 preterm neonates 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)].

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Injection: Dextrose hydrous and sodium chloride in clear, sterile, and nonpyrogenic solutions, available in single-dose EXCEL^®flexible containers (250 mL, 500 mL and 1000 mL) in the following concentrations:

3.3% (3.3 g/100 mL) (33 mg/mL) Dextrose and 0.3% (0.3 g/100 mL) (3 mg/mL) Sodium Chloride Injection, USP
5% (5 g/100 mL) (50 mg/mL) Dextrose and 0.9% (0.9 g/100 mL) (9 mg/mL) Sodium Chloride Injection, USP
5% (5 g/100 mL) (50 mg/mL) Dextrose and 0.45% (0.45 g/100 mL) (4.5 mg/mL) Sodium Chloride Injection, USP
5% (5 g/100 mL) (50 mg/mL) Dextrose and 0.33% (0.33 g/100 mL) (3.3 mg/mL) Sodium Chloride Injection, USP
5% (5 g/100 mL) (50 mg/mL) Dextrose and 0.2% (0.2 g/100 mL) (2 mg/mL) Sodium Chloride Injection, USP
10% (10 g/100 mL) (100 mg/mL) Dextrose and 0.45% (0.45 g/100 mL) (4.5 mg/mL) Sodium Chloride Injection, USP
10% (10 g/100 mL) (100 mg/mL) Dextrose and 0.2% (0.2 g/100 mL) (2 mg/mL) Sodium Chloride Injection, USP

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Dextrose and Sodium Chloride Injection is contraindicated in patients with:

Known hypersensitivity to dextrose and/or sodium chloride [see Warnings and
Precautions (5.2)]
Clinically significant hyperglycemia [see Warnings and Precautions (5.3)]

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

5.1 Neonatal Hypoglycemia

SPL UNCLASSIFIED SECTION

Neonates, especially preterm neonates with low birth weight, are at increased risk of developing hypoglycemia. Closely monitor blood glucose concentration during treatment with Dextrose and Sodium Chloride Injection to ensure adequate glycemic control in order to avoid potential long-term adverse effects.

5.2 Hypersensitivity Reactions

SPL UNCLASSIFIED SECTION

Hypersensitivity and infusion reactions, including anaphylaxis, have been reported with Dextrose and Sodium Chloride Injection [see Adverse Reactions (6)]. Stop administration of Dextrose and Sodium Chloride Injection immediately if signs or symptoms of a hypersensitivity reaction develop. Initiate appropriate treatment as clinically indicated.

5.3 Hyperglycemia and Hyperosmolar Hyperglycemic State

SPL UNCLASSIFIED SECTION

The use of Dextrose and Sodium Chloride Injection 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 (5.3, 5.4, 5.5), Use in Specific Populations (8.4)]. Patients with underlying central nervous system disease and renal impairment who receive dextrose infusions, may be at greater risk of developing hyperosmolar hyperglycemic state.

Monitor blood glucose concentrations and treat hyperglycemia to maintain concentrations within normal limits while administering Dextrose and Sodium Chloride Injection. Insulin may be administered or adjusted to maintain optimal blood glucose concentrations during Dextrose and Sodium Chloride Injection administration.

5.4 Hyponatremia

SPL UNCLASSIFIED SECTION

Dextrose and Sodium Chloride Injection may cause hyponatremia. 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)].

Rapid correction of hyponatremia is potentially dangerous with risk of serious neurologic complications such as osmotic demyelination syndrome (ODS) with risk of seizures and cerebral edema. To avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-based balance, and signs of neurologic complications.

Avoid Dextrose and Sodium Chloride Injection 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 (5.5, 5.6, 5.7)].

5.5 Hypokalemia

SPL UNCLASSIFIED SECTION

Excessive administration of Dextrose and Sodium Chloride Injection may result in significant hypokalemia. Hypokalemic periodic paralysis, metabolic alkalosis, increased gastrointestinal losses (e.g. diarrhea, vomiting), prolonged low potassium diet, or primary hyperaldosteronism may increase the risk of hypokalemia. Avoid the administration of Dextrose and Sodium Chloride Injection in patients with or at risk of hypokalemia or taking medications that may increase the risk. If use cannot be avoided, monitor serum potassium levels.

5.6 Hypernatremia and Hyperchloremia

SPL UNCLASSIFIED SECTION

Electrolyte imbalances such as hypernatremia and hyperchloremia, leading to metabolic acidosis may occur with solutions containing 0.9% sodium chloride.

Conditions that may increase the risk of hypernatremia, fluid overload, and edema (central and peripheral), include patients with pre-eclampsia, primary hyperaldosteronism and secondary hyperaldosteronism associated with, for example, hypertension, congestive heart failure, severe renal impairment, liver disease (including cirrhosis), and renal disease (including renal artery stenosis, nephrosclerosis).

Medications such as corticosteroids or corticotropin, may increase the risk of sodium and fluid retention.

Avoid solutions containing 0.9% sodium chloride in patients with or at risk for hypernatremia. If use cannot be avoided, monitor serum sodium concentrations.

5.7 Fluid Overload

SPL UNCLASSIFIED SECTION

Depending on the volume and rate of infusion, the patient's underlying clinical condition and capability to metabolize dextrose, intravenous administration of Dextrose and Sodium Chloride Injection can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.

Avoid Dextrose and Sodium Chloride Injection in patients with or at risk for fluid and/or solute overload. If use cannot be avoided, 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.

5.8 Phlebitis and Thrombosis

SPL UNCLASSIFIED SECTION

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.

5.9 Refeeding Syndrome

SPL UNCLASSIFIED SECTION

Refeeding severely undernourished patients may result in the refeeding syndrome that is characterized by the shift of potassium, phosphorus, and magnesium intracellularly 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

ADVERSE REACTIONS SECTION

Neonatal Hypoglycemia [see Warnings and Precautions (5.1)]
Hypersensitivity [see Warnings and Precautions (5.2)]
Hyperglycemia and Hyperosmolar Hyperglycemic State [see Warnings and Precautions (5.3)]
Hyponatremia [see Warnings and Precautions (5.4)]
Hypokalemia [see Warnings and Precautions (5.5)]
Hypernatremia and Hyperchloremia [see Warnings and Precautions (5.6)]
Fluid Overload [see Warnings and Precautions (5.7)]
Phlebitis and Thrombosis [see Warnings and Precautions (5.8)]
Refeeding syndrome [see Warnings and Precautions (5.9)]

The following adverse reactions associated with the use of Dextrose and Sodium Chloride Injection 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

DRUG INTERACTIONS SECTION

7.1 Effects on Glycemic Control, Vasopressin, Fluid, and Electrolyte Balance

SPL UNCLASSIFIED SECTION

Dextrose and Sodium Chloride Injection can affect glycemic control, vasopressin and fluid and/or electrolyte balance [see Warnings and Precautions (5.3, 5.4, 5.5, 5.6, 5.7)]. Monitor patients’ blood glucose concentrations, fluid balance, serum electrolyte concentrations, and acid-base balance.

Concomitant administration of Dextrose and Sodium Chloride Injection 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 and Sodium Chloride Injection in patients receiving drugs associated with hyponatremia. If use cannot be avoided, closely monitor serum sodium concentrations during concomitant use [see Warnings and Precautions (5.4)].

7.2 Lithium

SPL UNCLASSIFIED SECTION

Renal sodium and lithium clearance may be increased during administration of Dextrose and Sodium Chloride Injection resulting in decreased serum lithium concentrations. Monitor serum lithium concentrations during concomitant use.

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

8.1 Pregnancy

PREGNANCY SECTION

Risk Summary

Appropriate administration of Dextrose and Sodium Chloride Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with Dextrose and Sodium Chloride Injection.

Dextrose 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.

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

LACTATION SECTION

Risk Summary

Dextrose 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 on levels of glucose in human milk, on the breastfed infant, or on milk production.

Sodium is present in human breast milk. There are no data on the effects of Dextrose and Sodium Chloride Injection on a breastfed infant or the effects on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Dextrose and Sodium Chloride Injection and any potential adverse effects on the breastfed infant from Dextrose and Sodium Chloride Injection or from the underlying maternal condition.

8.4 Pediatric Use

PEDIATRIC USE SECTION

Dextrose and Sodium Chloride Injection is indicated in pediatric patients as a source of water, electrolytes, and calories.

The safety profile of Dextrose and Sodium Chloride Injection in pediatric patients is similar to adults.

Neonates, especially preterm neonates with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long-term adverse effects.

Dextrose and Sodium Chloride Injection 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 (5.4, 5.5, 5.6, 5.7)].

In very low birth weight infants, excessive or rapid administration of Dextrose and Sodium Chloride Injection may result in increased serum osmolality and risk of intracerebral hemorrhage.

8.5 Geriatric Use

GERIATRIC USE SECTION

Dextrose and Sodium Chloride Injection has not been studied in sufficient numbers 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 (5.4)]. 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 and Sodium Chloride Injection is known to be substantially excreted by the kidney, and the risk of adverse reactions to Dextrose and Sodium Chloride Injection may be greater in patients with impaired renal function [see Warnings and Precaution (5.6)].

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 and Sodium Chloride Injection treatment.

8.6 Renal Impairment

RENAL IMPAIRMENT SUBSECTION

Administration of Dextrose and Sodium Chloride Injection in patients with renal impairment may result in hyperosmolar hyperglycemic state, hyponatremia, and/or fluid overload. Monitor patients with renal impairment for development of these adverse reactions [see Warnings and Precautions (5.3, 5.4, 5.5, 5.6 , 5.7)].

10 OVERDOSAGE

OVERDOSAGE SECTION

Excessive administration of Dextrose and Sodium Chloride Injection can cause hyperglycemia, hyperosmolality, and adverse effects on fluid and electrolyte balance [see Warnings and Precautions (5.3, 5.7)].

Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal. In the event of overdosage (overhydration or solute overload) during Dextrose and Sodium Chloride Injection 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 (5.3, 5.7)].

11 DESCRIPTION

DESCRIPTION SECTION

Dextrose and Sodium Chloride Injection is a clear, sterile, nonpyrogenic solution and contains no bacteriostatic or antimicrobial agents. These products are intended for intravenous administration.

The structural formula and molecular weight of the active ingredients are:

Ingredients	Structural Formula	Molecular Weight
Sodium Chloride USP	NaCI	58.44
Hydrous Dextrose USP	Molecular Formula	198.17

Composition, osmolarity, pH, ionic concentration, and caloric content are shown in Table 1.

Table 1

	Size (mL)	Composition (g/100 mL)		*Osmolarity (mOsmol/L) (calc.)	pH	Ionic Concentration (mEq/L)		Caloric Content (kcal/L)
	Size (mL)	Dextrose Hydrous, USP	Sodium Chloride, USP (NaCl)	*Osmolarity (mOsmol/L) (calc.)	pH	Sodium	Chloride	Caloric Content (kcal/L)
3.3% Dextrose and 0.30% Sodium Chloride Injection USP	500 1000	3.3 g	0.3 g	270	4.5 (3.5-6.5)	51	51	110
5% Dextrose and 0.90% Sodium Chloride Injection USP	500 1000	5 g	0.9 g	560	4.4 (3.5-6.5)	154	154	170
5% Dextrose and 0.45% Sodium Chloride Injection USP	250 500 1000	5 g	0.45 g	405	4.4 (3.5-6.5)	77	77	170
5% Dextrose and 0.33% Sodium Chloride Injection USP	500 1000	5 g	0.33 g	365	4.4 (3.5-6.5)	56	56	170
5% Dextrose and 0.20% Sodium Chloride Injection USP	250 500 1000	5 g	0.2 g	320	4.4 (3.5-6.5)	34	34	170
10% Dextrose and 0.45% Sodium Chloride Injection USP	1000	10 g	0.45 g	660	4.3 (3.5-6.5)	77	77	340
10% Dextrose and 0.20% Sodium Chloride Injection USP	250	10 g	0.2 g	575	4.3 (3.5-6.5)	34	34	340

* Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L.

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

CLINICAL PHARMACOLOGY SECTION

12.1 Mechanism of Action

MECHANISM OF ACTION SECTION

Dextrose is a source of carbohydrate calories and is used to supplement nutrition by providing glucose parenterally. Sodium Chloride restores and maintains extracellular fluid volume and osmolality, while supporting membrane potential, nerve and muscle function, and acid-base balance.

12.2 Pharmacodynamics

SPL UNCLASSIFIED SECTION

The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of dextrose and sodium chloride have not been fully characterized.

Dextrose and Sodium Chloride Injection is capable of inducing diuresis depending on the clinical condition of the patient.

12.3 Pharmacokinetics

SPL UNCLASSIFIED SECTION

Dextrose is oxidized to carbon dioxide and water.

Sodium chloride is not metabolized. Sodium and chloride ions are distributed primarily in the extracellular fluid and are excreted by the kidneys.

13 NONCLINICAL TOXICOLOGY

SPL UNCLASSIFIED SECTION

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

SPL UNCLASSIFIED SECTION

Carcinogenicity, genetic toxicology, and animal fertility studies have not been performed with dextrose or sodium chloride.

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

How Supplied

Dextrose and Sodium Chloride Injections, USP are clear, sterile, and nonpyrogenic solutions supplied in EXCEL^® flexible containers as shown in the table below.

REF / Canada DIN	Size (mL)	NDC	Product Name	Package Configuration
L6080-00 / DIN 01927981	1000	0264-7608-00	3.3% Dextrose and 0.3% Sodium Chloride Injection USP	Case of 12
L6081-00 / DIN 01927981	500	0264-7608-10	3.3% Dextrose and 0.3% Sodium Chloride Injection USP	Case of 24
L6100 / DIN 01924435	1000	0264-7610-00	5% Dextrose and 0.9% Sodium Chloride Injection USP	Case of 12
L6101 / DIN 01924435	500	0264-7610-10	5% Dextrose and 0.9% Sodium Chloride Injection USP	Case of 24
L6120 / DIN 01927531	1000	0264-7612-00	5% Dextrose and 0.45% Sodium Chloride Injection USP	Case of 12
L6121 / DIN 01927531	500	0264-7612-10		Case of 24
L6122 / DIN 01927531	250	0264-7612-20		Case of 24
L6140	1000	0264-7614-00	5% Dextrose and 0.33% Sodium Chloride Injection USP	Case of 12
L6141	500	0264-7614-10	5% Dextrose and 0.33% Sodium Chloride Injection USP	Case of 24
L6160 / DIN 01927558	1000	0264-7616-00	5% Dextrose and 0.2% Sodium Chloride Injection USP	Case of 12
L6161 / DIN 01927558	500	0264-7616-10		Case of 24
L6162 / DIN 01927558	250	0264-7616-20		Case of 24
L6220	1000	0264-7622-00	10% Dextrose and 0.45% Sodium Chloride Injection USP	Case of 12
L6232	250	0264-7623-20	10% Dextrose and 0.2% Sodium Chloride Injection USP	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 and Sodium Chloride Injection 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

Y36-003-114 LD-197-5

PRINCIPAL DISPLAY PANEL - 1000 mL Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3.3% Dextrose and
0.30% Sodium Chloride
Injection USP

REF L6080-00
NDC 0264-7608-00
DIN 01927981

1000 mL
EXCEL^® CONTAINER

Each 100 mL contains: Hydrous Dextrose USP 3.3 g;
Sodium Chloride USP 0.3 g; Water for Injection USP qs

pH: 4.5 (3.5-6.5); Calc. Osmolarity: 270 mOsmol/liter

Electrolytes (mEq/liter): Na⁺51; Cl^–51

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: Do Not Administer Simultaneously With
Blood. 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

7-Other logo

EXCEL is a registered trademark of B. Braun Medical Inc.

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

Y94-003-252
LD-183-3

EXP
LOT

PRINCIPAL DISPLAY PANEL - 500 mL Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3.3% Dextrose and
0.30% Sodium Chloride
Injection USP

REF L6081-00
NDC 0264-7608-10
DIN 01927981

500 mL
EXCEL^® CONTAINER

Each 100 mL contains: Hydrous Dextrose USP 3.3 g; Sodium Chloride USP 0.3 g;
Water for Injection USP qs

pH: 4.5 (3.5-6.5); Calc. Osmolarity: 270 mOsmol/liter

Electrolytes (mEq/liter): Na⁺51; Cl^– 51

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: Do Not Administer Simultaneously With Blood. 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

Logo

EXCEL is a registered trademark of B. Braun Medical Inc.

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

Y94-003-246
LD-184-3

EXP
LOT

PRINCIPAL DISPLAY PANEL - 1000 mL Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5% Dextrose and
0.9% Sodium Chloride
Injection USP

REF L6100
NDC 0264-7610-00
DIN 01924435
HK 22608

1000 mL
EXCEL^® CONTAINER

Each 100 mL contains: Hydrous Dextrose USP 5 g;
Sodium Chloride USP 0.9 g; Water for Injection USP qs

pH: 4.4 (3.5-6.5); Calc. Osmolarity: 560 mOsmol/liter,
hypertonic

Electrolytes (mEq/liter): Na⁺ 154; Cl^– 154

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: 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

Logo

EXCEL is a registered trademark of B. Braun Medical Inc.

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

Y94-003-253
LD-177-3

EXP
LOT

PRINCIPAL DISPLAY PANEL - 500 mL Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5% Dextrose and
0.9% Sodium Chloride
Injection USP

REF L6101
NDC 0264-7610-10
DIN 01924435
HK 22608

500 mL
EXCEL^® CONTAINER

Each 100 mL contains: Hydrous Dextrose USP 5 g; Sodium Chloride USP 0.9 g;
Water for Injection USP qs

pH: 4.4 (3.5-6.5); Calc. Osmolarity: 560 mOsmol/liter, hypertonic

Electrolytes (mEq/liter): Na⁺ 154; Cl^– 154

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: 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

Logo

EXCEL is a registered trademark of B. Braun Medical Inc.

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

Y94-003-247
LD-176-3

EXP
LOT

PRINCIPAL DISPLAY PANEL - 1000 mL Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5% Dextrose and
0.45% Sodium Chloride
Injection USP

REF L6120
NDC 0264-7612-00
DIN 01927531
HK 22607

1000 mL
EXCEL^® CONTAINER

Each 100 mL contains: Hydrous Dextrose USP 5 g;
Sodium Chloride USP 0.45 g; Water for Injection USP qs

pH: 4.4 (3.5-6.5); Calc. Osmolarity: 405 mOsmol/liter,
hypertonic

Electrolytes (mEq/liter): Na⁺ 77; Cl^– 77

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: 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

Logo

EXCEL is a registered trademark of B. Braun Medical Inc.

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

Y94-003-254
LD-108-3

EXP
LOT

PRINCIPAL DISPLAY PANEL - 500 mL Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5% Dextrose and
0.45% Sodium Chloride
Injection USP

REF L6121
NDC 0264-7612-10
DIN 01927531
HK 22607

500 mL
EXCEL^® CONTAINER

Each 100 mL contains: Hydrous Dextrose USP 5 g; Sodium Chloride USP 0.45 g;
Water for Injection USP qs

pH: 4.4 (3.5-6.5); Calc. Osmolarity: 405 mOsmol/liter, hypertonic

Electrolytes (mEq/liter): Na⁺ 77; Cl^– 77

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: 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

Logo

EXCEL is a registered trademark of B. Braun Medical Inc.

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

Y94-003-248
LD-113-3

EXP
LOT

PRINCIPAL DISPLAY PANEL - 250 mL Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5% Dextrose and
0.45% Sodium Chloride
Injection USP

REF L6122
NDC 0264-7612-20
DIN 01927531
HK 22607

250 mL
EXCEL^® CONTAINER

Each 100 mL contains: Hydrous Dextrose USP 5 g; Sodium
Chloride USP 0.45 g; Water for Injection USP qs

pH: 4.4 (3.5-6.5); Calc. Osmolarity: 405 mOsmol/liter,
hypertonic

Electrolytes (mEq/liter): Na⁺ 77; Cl^– 77

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: 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

Logo

EXCEL is a registered trademark of B. Braun Medical Inc.

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

Y94-003-245
LD-114-3

EXP
LOT

PRINCIPAL DISPLAY PANEL - 1000 mL Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5% Dextrose and
0.33% Sodium Chloride
Injection USP

REF L6140
NDC 0264-7614-00

1000 mL
EXCEL^® CONTAINER

Each 100 mL contains: Hydrous Dextrose USP 5 g;
Sodium Chloride USP 0.33 g; Water for Injection USP qs

pH: 4.4 (3.5-6.5); Calc. Osmolarity: 365 mOsmol/liter,
hypertonic

Electrolytes (mEq/liter): Na⁺ 56; Cl^– 56

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: Do Not Administer Simultaneously With Blood.
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

Logo

EXCEL is a registered trademark of B. Braun Medical Inc.

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Y94-003-255
LD-115-3

EXP
LOT

PRINCIPAL DISPLAY PANEL - 500 mL Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5% Dextrose and
0.33% Sodium Chloride
Injection USP

REF L6141
NDC 0264-7614-10

500 mL
EXCEL^® CONTAINER

Each 100 mL contains: Hydrous Dextrose USP 5 g; Sodium Chloride USP 0.33 g;
Water for Injection USP qs

pH: 4.4 (3.5-6.5); Calc. Osmolarity: 365 mOsmol/liter, hypertonic

Electrolytes (mEq/liter): Na⁺ 56; Cl^– 56

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: Do Not Administer Simultaneously With Blood. 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

Logo

EXCEL is a registered trademark of B. Braun Medical Inc.

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Y94-003-249
LD-174-3

EXP
LOT

PRINCIPAL DISPLAY PANEL - 1000 mL Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5% Dextrose and
0.20% Sodium Chloride
Injection USP

REF L6160
NDC 0264-7616-00
DIN 01927558
HK 22606

1000 mL
EXCEL^® CONTAINER

Each 100 mL contains: Hydrous Dextrose USP 5 g;
Sodium Chloride USP 0.2 g; Water for Injection USP qs

pH: 4.4 (3.5-6.5); Calc. Osmolarity: 320 mOsmol/liter

Electrolytes (mEq/liter): Na⁺ 34 ; Cl^– 34

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: Do Not Administer Simultaneously With Blood.
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

Logo

EXCEL is a registered trademark of B. Braun Medical Inc.

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

Y94-003-256
LD-172-3

EXP
LOT

PRINCIPAL DISPLAY PANEL - 500 mL Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5% Dextrose and
0.20% Sodium Chloride
Injection USP

REF L6161
NDC 0264-7616-10
DIN 01927558
HK 22606

500 mL
EXCEL^® CONTAINER

Each 100 mL contains: Hydrous Dextrose USP 5 g; Sodium Chloride USP 0.2 g;
Water for Injection USP qs

pH: 4.4 (3.5-6.5); Calc. Osmolarity: 320 mOsmol/liter

Electrolytes (mEq/liter): Na+ 34; Cl^– 34

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: Do Not Administer Simultaneously With Blood. 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

Logo

EXCEL is a registered trademark of B. Braun Medical Inc.

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

Y94-003-250
LD-112-3

EXP
LOT

PRINCIPAL DISPLAY PANEL - 250 mL Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5% Dextrose and
0.20% Sodium Chloride
Injection USP

REF L6162
NDC 0264-7616-20
DIN 01927558
HK 22606

250 mL
EXCEL^® CONTAINER

Each 100 mL contains: Hydrous Dextrose USP 5 g; Sodium
Chloride USP 0.2 g; Water for Injection USP qs

pH: 4.4 (3.5-6.5); Calc. Osmolarity: 320 mOsmol/liter

Electrolytes (mEq/liter): Na⁺ 34; Cl^– 34

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: Do Not Administer Simultaneously With Blood. 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

Logo

EXCEL is a registered trademark of B. Braun Medical Inc.

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

Y94-003-258
LD-171-3

EXP
LOT

PRINCIPAL DISPLAY PANEL - 1000 mL Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10% Dextrose and
0.45% Sodium Chloride
Injection USP

REF L6220
NDC 0264-7622-00

1000 mL
EXCEL^® CONTAINER

Each 100 mL contains: Hydrous Dextrose USP 10 g;
Sodium Chloride USP 0.45 g; Water for Injection USP qs

pH: 4.3 (3.5-6.5); Calc. Osmolarity: 660 mOsmol/liter,
hypertonic

Electrolytes (mEq/liter): Na⁺ 77; Cl^– 77

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:
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

Logo

EXCEL is a registered trademark of B. Braun Medical Inc.

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Y94-003-257
LD-170-3

EXP
LOT

PRINCIPAL DISPLAY PANEL - 250 mL Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10% Dextrose and
0.20% Sodium Chloride
Injection USP

REF L6232
NDC 0264-7623-20

250 mL
EXCEL^® CONTAINER

Each 100 mL contains: Hydrous Dextrose USP 10 g;
Sodium Chloride USP 0.2 g; Water for Injection USP qs

pH: 4.3 (3.5-6.5); Calc. Osmolarity: 575 mOsmol/liter,
hypertonic

Electrolytes (mEq/liter): Na⁺ 34; Cl^– 34

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: Do Not Administer Simultaneously With Blood.
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

Logo

EXCEL is a registered trademark of B. Braun Medical Inc.

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Y94-003-259
LD-169-4

EXP
LOT

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0264-7605-00	ML - Milliliter	0264-7605	5d099c71-bb24-43eb-85df-19aee7278236	1	2012-07-24
0264-7605-10	ML - Milliliter	0264-7605	af25236f-b12c-4d83-9738-733bb0a1bc09	1	2012-07-24
0264-7610-00	ML - Milliliter	0264-7610	fab068f7-5178-45cb-8d39-2c622d2de21b	1	2012-07-24
0264-7610-10	ML - Milliliter	0264-7610	aaed45a7-069c-4013-90ad-fad3aeb0277a	1	2012-07-24
0264-7610-20	ML - Milliliter	0264-7610	9fd29b7e-1724-4bd9-b46c-39b5d2ecc371	1	2012-07-24
0264-7612-00	ML - Milliliter	0264-7612	a96bfc5f-4d34-469a-8fd6-702869ab96ad	1	2012-07-24
0264-7612-10	ML - Milliliter	0264-7612	cff733d4-851c-4b32-9767-f251f8b6177d	1	2012-07-24
0264-7612-20	ML - Milliliter	0264-7612	69fab7f7-4378-49d3-88f9-620705469fac	1	2012-07-24
0264-7614-00	ML - Milliliter	0264-7614	d7094e70-bd2b-4851-ac78-3286b6921120	1	2012-07-24
0264-7614-10	ML - Milliliter	0264-7614	3ee43311-b5c7-4ff4-9b4e-0bb237681390	1	2012-07-24
0264-7616-00	ML - Milliliter	0264-7616	4b1748ae-fbf0-43e4-9153-9768f62f11e8	1	2012-07-24
0264-7616-10	ML - Milliliter	0264-7616	492f37dc-9e1a-481d-9731-0a4ad0541f83	1	2012-07-24
0264-7616-20	ML - Milliliter	0264-7616	b19e609a-3e0b-4d71-96ce-b9ed20c12563	1	2012-07-24
0264-7622-00	ML - Milliliter	0264-7622	ebddb4f5-9272-4a11-a0e6-43dc606faa4b	1	2012-07-24
0264-7623-20	ML - Milliliter	0264-7623	58d164b5-638e-4c96-a99b-c4905f68032f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DEXTROSE	ACTIVE INGREDIENT	IY9XDZ35W2	7
SODIUM CHLORIDE	ACTIVE INGREDIENT	451W47IQ8X	7
DEXTROSE	ACTIVE MOIETY	IY9XDZ35W2	7
SODIUM CATION	ACTIVE MOIETY	LYR4M0NH37	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	7

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

Dextrose And Sodium Chloride
DEXTROSE, UNSPECIFIED FORM
ANHYDROUS DEXTROSE
SODIUM CHLORIDE
SODIUM CATION
CHLORIDE ION
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0264-7605	0264-7605-00, 0264-7605-10
0264-7608	0264-7608-00, 0264-7608-10
0264-7610	0264-7610-00, 0264-7610-10, 0264-7610-20
0264-7612	0264-7612-00, 0264-7612-10, 0264-7612-20
0264-7614	0264-7614-00, 0264-7614-10
0264-7616	0264-7616-00, 0264-7616-10, 0264-7616-20
0264-7622	0264-7622-00
0264-7623	0264-7623-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DEXTROSE, UNSPECIFIED FORM	IY9XDZ35W2	ACTIB
SODIUM CHLORIDE	451W47IQ8X	ACTIB
WATER	059QF0KO0R	IACT
DEXTROSE, UNSPECIFIED FORM	IY9XDZ35W2	ACTIB
SODIUM CHLORIDE	451W47IQ8X	ACTIB
WATER	059QF0KO0R	IACT
DEXTROSE, UNSPECIFIED FORM	IY9XDZ35W2	ACTIB
SODIUM CHLORIDE	451W47IQ8X	ACTIB
WATER	059QF0KO0R	IACT
DEXTROSE, UNSPECIFIED FORM	IY9XDZ35W2	ACTIB
SODIUM CHLORIDE	451W47IQ8X	ACTIB
WATER	059QF0KO0R	IACT
DEXTROSE, UNSPECIFIED FORM	IY9XDZ35W2	ACTIB
SODIUM CHLORIDE	451W47IQ8X	ACTIB
WATER	059QF0KO0R	IACT
DEXTROSE, UNSPECIFIED FORM	IY9XDZ35W2	ACTIB
SODIUM CHLORIDE	451W47IQ8X	ACTIB
WATER	059QF0KO0R	IACT
DEXTROSE, UNSPECIFIED FORM	IY9XDZ35W2	ACTIB
SODIUM CHLORIDE	451W47IQ8X	ACTIB
WATER	059QF0KO0R	IACT
DEXTROSE, UNSPECIFIED FORM	IY9XDZ35W2	ACTIB
SODIUM CHLORIDE	451W47IQ8X	ACTIB
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
16	2024-04-02	full-release	2026-05-31 21:01:55

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 16 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
N019631-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	2.5GM/100ML;110MG/100ML	INJECTABLE / INJECTION		1988-02-24
N019631-002	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	2.5GM/100ML;200MG/100ML	INJECTABLE / INJECTION		1988-02-24
N019631-003	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	2.5GM/100ML;330MG/100ML	INJECTABLE / INJECTION		1988-02-24
N019631-004	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24
N019631-005	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	2.5GM/100ML;900MG/100ML	INJECTABLE / INJECTION		1988-02-24
N019631-006	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION		1988-02-24
N019631-007	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24
N019631-008	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24
N019631-009	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24
N019631-010	DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	5GM/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24
N019631-011	DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	10GM/100ML;110MG/100ML	INJECTABLE / INJECTION		1988-02-24
N019631-012	DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	10GM/100ML;200MG/100ML	INJECTABLE / INJECTION		1988-02-24
N019631-013	DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	10GM/100ML;330MG/100ML	INJECTABLE / INJECTION		1988-02-24
N019631-014	DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	10GM/100ML;450MG/100ML	INJECTABLE / INJECTION		1988-02-24
N019631-015	DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	10GM/100ML;900MG/100ML	INJECTABLE / INJECTION		1988-02-24
N019631-016	DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	3.3GM/100ML;300MG/100ML	INJECTABLE / INJECTION		1990-01-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N019631-004	AP
N019631-007	AP
N019631-008	AP
N019631-009	AP
N019631-010	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.

Product history page 1 of 18 · 704 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N019631-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	2.5GM/100ML;110MG/100ML	INJECTABLE / INJECTION		1988-02-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019631-002	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	2.5GM/100ML;200MG/100ML	INJECTABLE / INJECTION		1988-02-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019631-003	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	2.5GM/100ML;330MG/100ML	INJECTABLE / INJECTION		1988-02-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019631-004	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019631-005	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	2.5GM/100ML;900MG/100ML	INJECTABLE / INJECTION		1988-02-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019631-006	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION		1988-02-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019631-007	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019631-008	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019631-009	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019631-010	DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	5GM/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019631-011	DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	10GM/100ML;110MG/100ML	INJECTABLE / INJECTION		1988-02-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019631-012	DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	10GM/100ML;200MG/100ML	INJECTABLE / INJECTION		1988-02-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019631-013	DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	10GM/100ML;330MG/100ML	INJECTABLE / INJECTION		1988-02-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019631-014	DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	10GM/100ML;450MG/100ML	INJECTABLE / INJECTION		1988-02-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019631-015	DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	10GM/100ML;900MG/100ML	INJECTABLE / INJECTION		1988-02-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019631-016	DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	3.3GM/100ML;300MG/100ML	INJECTABLE / INJECTION		1990-01-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N019631-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	2.5GM/100ML;110MG/100ML	INJECTABLE / INJECTION		1988-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019631-002	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	2.5GM/100ML;200MG/100ML	INJECTABLE / INJECTION		1988-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019631-003	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	2.5GM/100ML;330MG/100ML	INJECTABLE / INJECTION		1988-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019631-004	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019631-005	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	2.5GM/100ML;900MG/100ML	INJECTABLE / INJECTION		1988-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019631-006	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION		1988-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019631-007	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019631-008	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019631-009	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019631-010	DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	5GM/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019631-011	DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	10GM/100ML;110MG/100ML	INJECTABLE / INJECTION		1988-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019631-012	DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	10GM/100ML;200MG/100ML	INJECTABLE / INJECTION		1988-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019631-013	DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	10GM/100ML;330MG/100ML	INJECTABLE / INJECTION		1988-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019631-014	DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	10GM/100ML;450MG/100ML	INJECTABLE / INJECTION		1988-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019631-015	DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	10GM/100ML;900MG/100ML	INJECTABLE / INJECTION		1988-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019631-016	DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	3.3GM/100ML;300MG/100ML	INJECTABLE / INJECTION		1990-01-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019631-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	2.5GM/100ML;110MG/100ML	INJECTABLE / INJECTION		1988-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-002	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	2.5GM/100ML;200MG/100ML	INJECTABLE / INJECTION		1988-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-003	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	2.5GM/100ML;330MG/100ML	INJECTABLE / INJECTION		1988-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-004	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-005	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	2.5GM/100ML;900MG/100ML	INJECTABLE / INJECTION		1988-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-006	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION		1988-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-007	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-008	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24	`caaa826d4ba7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N019631-004	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019631-007	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019631-008	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019631-009	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019631-010	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N019631-004	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019631-007	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019631-008	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019631-009	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019631-010	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019631-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-007	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-008	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-009	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-010	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019631-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019631-007	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019631-008	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019631-009	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019631-010	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019631-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019631-007	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019631-008	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019631-009	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019631-010	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019631-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019631-007	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019631-008	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019631-009	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019631-010	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019631-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019631-007	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019631-008	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019631-009	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019631-010	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019631-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019631-007	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019631-008	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019631-009	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019631-010	AP	1	`b8a1b40f171c…`

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dextrose And Sodium Chloride	DEXTROSE AND SODIUM CHLORIDE	B. Braun Medical Inc.	8e6569ce-9714-497f-a94b-c6975c1d76f6	2024-04-02	Warnings, Adverse reactions	Exact identifier ndc (package): 0264-7610-20 ndc (package): 0264-7610-10 ndc (package): 0264-7605-00 ndc (package): 0264-7623-20 ndc (package): 0264-7608-10 ndc (package): 0264-7608-00 ndc (package): 0264-7612-20 ndc (package): 0264-7610-00 ndc (package): 0264-7616-00 ndc (package): 0264-7605-10 ndc (package): 0264-7616-20 ndc (package): 0264-7612-00 ndc (package): 0264-7614-00 ndc (package): 0264-7616-10 ndc (package): 0264-7612-10 ndc (package): 0264-7622-00 ndc (package): 0264-7614-10 ndc (product): 0264-7605 ndc (product): 0264-7614 ndc (product): 0264-7612 ndc (product): 0264-7622 ndc (product): 0264-7610 ndc (product): 0264-7616 ndc (product): 0264-7608 ndc (product): 0264-7623 ndc11 (package): 00264762320 ndc11 (package): 00264761000 ndc11 (package): 00264760500 ndc11 (package): 00264761210 ndc11 (package): 00264761020 ndc11 (package): 00264761600 ndc11 (package): 00264761410 ndc11 (package): 00264761610 ndc11 (package): 00264761620 ndc11 (package): 00264761220 ndc11 (package): 00264762200 ndc11 (package): 00264761400 ndc11 (package): 00264760510 ndc11 (package): 00264760810 ndc11 (package): 00264761010 ndc11 (package): 00264761200 ndc11 (package): 00264760800 spl set id: 8e6569ce-9714-497f-a94b-c6975c1d76f6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.