Dextrose

Manufacturer: ICU Medical, Inc. | Hospira, Inc. | Otsuka ICU Medical LLC
Effective date: 2025-11-02
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 18
Source: daily-update
Hydrated at: 2026-07-15 00:33:32

Label at a glance#

ProductDextrose

Active ingredientDEXTROSE MONOHYDRATE

Label structure17 sections

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.

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) ] . Do not administer Dextrose Injection (5% and 10%)...

Storage and handling

Dextrose Injection, USP (5% and 10%) is a clear, sterile, nonpyrogenic solution of dextrose supplied in single-dose flexible plastic containers as shown in the accompanying Table. NDC No. Product Container size (mL) 0990-7922-61 Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USA 5% Dextrose Injection, USP (5 g / 100 mL (50 mg/mL)) 150 0990-7922-53 Manufactured for ICU Medical, Inc., Lake Forest, ...

Contacts and useful links#

PhoneLabel contact1-800-441-4100

PhoneFDA MedWatch1-800-FDA-1088

Websitewww.fda.gov

www.fda.gov/medwatch

Label contents#

Full prescribing information#

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

2.1 Important Administration Instructions

SPL UNCLASSIFIED SECTION

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)].
Do not administer Dextrose Injection (5% and 10%) simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis.
Use of a final filter is recommended during administration of parenteral solutions, where possible.
Discard the unused portion.
Avoid use with chemotherapy agents. Consult the specific chemotherapy agent prescribing information to determine the appropriate diluent.

2.2 Important Preparation Information

SPL UNCLASSIFIED SECTION

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.
If using a pumping device to administer Dextrose Injection (5% and 10%), turn off the pump before the container is empty.

SPL UNCLASSIFIED SECTION

To Open:

Tear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration.

SPL UNCLASSIFIED SECTION

To Add Medication:

Prepare additive port.
Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication.
The additive port may be protected by covering with an additive cap.
Mix container contents thoroughly.

SPL UNCLASSIFIED SECTION

Preparation for Administration

(Use aseptic technique)

Close flow control clamp of administration set.
Remove cover from outlet port at bottom of container.
Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: When using a vented administration set, replace bacterial retentive air filter with piercing pin cover. Insert piercing pin with twisting motion until shoulder of air filter housing rests against the outlet port flange.
Suspend container from hanger.
Squeeze and release drip chamber to establish proper fluid level in chamber.
Attach venipuncture device to set.
Open clamp to expel air from set and venipuncture device. Close clamp.
Perform venipuncture.
Regulate rate of administration with flow control clamp.

2.3 Dosage Considerations

SPL UNCLASSIFIED SECTION

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 premature infants 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

DOSAGE FORMS & STRENGTHS SECTION

Injection:

5% (5 g/100 mL) (50 mg/mL) of dextrose hydrous in a clear, sterile, and nonpyrogenic solution in single-dose flexible containers: 25 mL, 50 mL, 100 mL, 150 mL, 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 flexible containers: 250 mL, 500 mL, and 1000 mL

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

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

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 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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

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.

5.5 Hyponatremia

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

ADVERSE REACTIONS SECTION

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, pruritis, pyrexia, rash

Cardiovascular disorders: cyanosis, volume overload

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

7.1 Drugs with Effects on Glycemic Control and Electrolyte Balance

SPL UNCLASSIFIED SECTION

Dextrose Injection (5% and 10%) can affect glycemic control, vasopressin, and fluid and/or electrolyte balance [see Warnings and Precautions (5.1, 5.2, 5.4, 5.5)]. 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

USE IN SPECIFIC POPULATIONS SECTION

8.1 Pregnancy

PREGNANCY SECTION

SPL UNCLASSIFIED SECTION

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

LACTATION SECTION

SPL UNCLASSIFIED SECTION

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

PEDIATRIC USE SECTION

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 premature infants 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

GERIATRIC USE SECTION

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

OVERDOSAGE SECTION

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, 5.6)].

11 DESCRIPTION

DESCRIPTION SECTION

Dextrose, USP is chemically designated D-glucose monohydrate (C₆H₁₂O₆ ∙ H₂O), a hexose sugar freely soluble in water.

The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula:

Water for Injection, USP is chemically designated H₂O.

Dextrose Injection, USP (5% and 10%) solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of dextrose in water for injection intended for intravenous administration.

Each 100 mL of 5% Dextrose Injection, USP, contains dextrose, hydrous 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic.

Each 100 mL of 10% Dextrose Injection, USP, contains dextrose, hydrous 10 g in water for injection. The caloric value is 340 kcal/L. The osmolarity is 505 mOsmol/L (calc.), which is hypertonic.

The pH for both concentrations is 4.3 (range is 3.2 to 6.5).

The solutions contain no bacteriostatic, antimicrobial agent or added buffer and each is supplied as single-dose containers.

Dextrose is derived from corn.

Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

12.1 Mechanism of Action

MECHANISM OF ACTION SECTION

Dextrose provides a source of carbohydrate calories and is used to supplement nutrition by providing glucose parenterally.

12.2 Pharmacodynamics

PHARMACODYNAMICS SECTION

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

PHARMACOKINETICS SECTION

Dextrose is oxidized to carbon dioxide and water.

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

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 SECTION

Dextrose Injection, USP (5% and 10%) is a clear, sterile, nonpyrogenic solution of dextrose supplied in single-dose flexible plastic containers as shown in the accompanying Table.

NDC No.	Product	Container size (mL)
0990-7922-61^*	5% Dextrose Injection, USP (5 g / 100 mL (50 mg/mL))	150
0990-7922-53^†	5% Dextrose Injection, USP (5 g / 100 mL (50 mg/mL))	250
0990-7922-02^*	5% Dextrose Injection, USP (5 g / 100 mL (50 mg/mL))	250
0990-7922-03^* ^, ^†	5% Dextrose Injection, USP (5 g / 100 mL (50 mg/mL))	500
0990-7922-55^* ^, ^†	5% Dextrose Injection, USP (5 g / 100 mL (50 mg/mL))	500
0990-7922-09^* ^, ^†	5% Dextrose Injection, USP (5 g / 100 mL (50 mg/mL))	1000
0990-7923-20^*	5% Dextrose Injection, USP (5 g / 100 mL (50 mg/mL))	25
0990-7923-36^*	5% Dextrose Injection, USP (5 g / 100 mL (50 mg/mL))	50
0990-7923-13^*	5% Dextrose Injection, USP (5 g / 100 mL (50 mg/mL))	50
0990-7923-23^*	5% Dextrose Injection, USP (5 g / 100 mL (50 mg/mL))	100
0990-7923-37^*	5% Dextrose Injection, USP (5 g / 100 mL (50 mg/mL))	100
0990-7930-02^*	10% Dextrose Injection, USP (10 g / 100 mL (100 mg/mL))	250
0990-7930-03^* ^, ^†	10% Dextrose Injection, USP (10 g / 100 mL (100 mg/mL))	500
0990-7930-09^* ^, ^†	10% Dextrose Injection, USP (10 g / 100 mL (100 mg/mL))	1000

* Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

† Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

STORAGE AND HANDLING SECTION

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].

Protect from freezing.

SPL UNCLASSIFIED SECTION

IFU0000541

icumedical

PRINCIPAL DISPLAY PANEL - 100 mL Bag Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 mL
NDC 0990-7923-37

5% Dextrose
Injection, USP

EACH 100 mL CONTAINS DEXTROSE,
HYDROUS 5 g.
252 mOsmol/LITER (CALC). pH 4.3 (3.2 to 6.5).
DEXTROSE SOLUTIONS WITHOUT
SALTS SHOULD NOT BE USED IN BLOOD
TRANSFUSIONS BECAUSE OF POSSIBLE
ROULEAU FORMATION. ADDITIVES MAY BE
INCOMPATIBLE. SINGLE-DOSE CONTAINER.
FOR I.V. USE. USUAL DOSAGE: SEE INSERT.
STERILE, NONPYROGENIC. USE ONLY IF
SOLUTION IS CLEAR AND CONTAINER IS
UNDAMAGED. MUST NOT BE USED IN
SERIES CONNECTIONS.

Rx ONLY

ICU Medical, Inc.,
Lake Forest, Illinois, 60045, USA
IM-4313

3
V
CONTAINS DEHP

icumedical

PRINCIPAL DISPLAY PANEL - 100 mL Bag Label

PRINCIPAL DISPLAY PANEL - 250 mL Bag Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

250 mL
NDC 0990-7922-53

5% DEXTROSE
Injection, USP

EACH 100 mL CONTAINS DEXTROSE,
HYDROUS 5 g IN WATER FOR
INJECTION.
252 mOsmol/LITER (CALC.)
pH 4.3 (3.2 to 6.5)
DEXTROSE SOLUTIONS WITHOUT
SALTS SHOULD NOT BE USED IN
BLOOD TRANSFUSIONS BECAUSE OF
POSSIBLE ROULEAU FORMATION.
ADDITIVES MAY BE INCOMPATIBLE.
CONSULT WITH PHARMACIST, IF
AVAILABLE. WHEN INTRODUCING
ADDITIVES, USE ASEPTIC TECHNIQUE,
MIX THOROUGHLY AND DO NOT
STORE. SINGLE-DOSE CONTAINER.
FOR I.V. USE. USUAL DOSAGE: SEE
INSERT. STERILE, NONPYROGENIC.
USE ONLY IF SOLUTION IS CLEAR
AND CONTAINER IS UNDAMAGED.
MUST NOT BE USED IN SERIES
CONNECTIONS.

Rx ONLY

3
V
CONTAINS DEHP

IM-4428
Manufactured for ICU Medical, Inc.,
Lake Forest, Illinois, 60045, USA

icumedical

PRINCIPAL DISPLAY PANEL - 250 mL Bag Label

PRINCIPAL DISPLAY PANEL - 500 mL Bag Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 mL
NDC 0990-7930-03

10% DEXTROSE
Injection, USP

EACH 100 mL CONTAINS DEXTROSE, HYDROUS 10 g IN
WATER FOR INJECTION.
505 mOsmol/LITER (CALC.)
pH 4.3 (3.2 to 6.5)
DEXTROSE SOLUTIONS WITHOUT SALTS SHOULD
NOT BE USED IN BLOOD TRANSFUSIONS BECAUSE
OF POSSIBLE ROULEAU FORMATION. ADDITIVES MAY
BE INCOMPATIBLE. CONSULT WITH PHARMACIST,
IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE
ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT
STORE. SINGLE-DOSE CONTAINER. FOR INTRAVENOUS
OR SUBCUTANEOUS USE. USUAL DOSAGE: SEE INSERT.
STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS
CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE
USED IN SERIES CONNECTIONS.

Rx ONLY

3
V
CONTAINS DEHP

icumedical

ICU Medical, Inc., Lake Forest, Illinois, 60045, USA
IM-4454

PRINCIPAL DISPLAY PANEL - 500 mL Bag Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0990-7922-02	ML - Milliliter	0990-7922	77ab64fe-2857-430f-9f21-a61fea2f90cc	1	2020-01-03
0990-7922-03	ML - Milliliter	0990-7922	1228635a-10a0-4052-8249-164a239a14ac	1	2020-07-13
0990-7922-09	ML - Milliliter	0990-7922	c757dd40-5cd4-49b3-b357-2c7ff03aa541	1	2020-03-10
0990-7922-25	ML - Milliliter	0990-7922	9cc83c48-9eb9-4584-88ee-f2136c899459	1	2020-07-13
0990-7922-53	ML - Milliliter	0990-7922	fea18487-30de-49c9-8e0e-6ffc079ca47b	1	2025-08-11
0990-7922-55	ML - Milliliter	0990-7922	2fb83bf2-ea3a-461f-8631-e6ce50d5b386	1	2020-01-03
0990-7922-61	ML - Milliliter	0990-7922	56f44477-3708-40e6-a9ed-d9403008d657	1	2020-02-13
0990-7923-11	ML - Milliliter	0990-7923	60ec6338-519f-40f9-ac1b-5ed50ef046c0	1	2020-07-13
0990-7923-13	ML - Milliliter	0990-7923	3f5c8d87-7337-4c81-8767-025b697b649d	1	2020-07-13
0990-7923-20	ML - Milliliter	0990-7923	988f9a36-8659-4d88-9d99-ceea8e9d1992	1	2020-05-08
0990-7923-23	ML - Milliliter	0990-7923	d3bca08f-e6aa-45ef-87b5-64cee7e9d45a	1	2020-06-05
0990-7923-36	ML - Milliliter	0990-7923	f9612d2b-2ccb-4b56-af07-3e28670a4e6c	1	2020-05-08
0990-7923-37	ML - Milliliter	0990-7923	83675906-284f-461f-9781-d3fcc9e166af	1	2020-03-10
0990-7930-02	ML - Milliliter	0990-7930	2aee413e-070c-4527-b0d2-40ed731a13a9	1	2019-09-05
0990-7930-03	ML - Milliliter	0990-7930	e6853d2f-79a1-454b-a616-53bbf7b0c1d3	1	2021-01-08

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

Dextrose
dextrose monohydrate
ANHYDROUS DEXTROSE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0990-7922	0990-7922-02, 0990-7922-03, 0990-7922-09, 0990-7922-53, 0990-7922-55, 0990-7922-61
0990-7923	0990-7923-20, 0990-7923-23, 0990-7923-36, 0990-7923-37, 0990-7923-13
0990-7930	0990-7930-02, 0990-7930-03, 0990-7930-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DEXTROSE MONOHYDRATE	LX22YL083G	ACTIB
WATER	059QF0KO0R	IACT
DEXTROSE MONOHYDRATE	LX22YL083G	ACTIB
WATER	059QF0KO0R	IACT
DEXTROSE MONOHYDRATE	LX22YL083G	ACTIB
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
17	2025-11-02	full-release	2026-05-31 22:03:53
15	2025-06-18	full-release	2026-05-31 21:35:44

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 · 2 matching rows.

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N016367-002	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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-10-15 13:18:30	2026-09	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 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	N016367-002	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N016367-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016367-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016367-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016367-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016367-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016367-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016367-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016367-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016367-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016367-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016367-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016367-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016367-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016367-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016367-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016367-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016367-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016367-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016367-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016367-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016367-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016367-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016367-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016367-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016367-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016367-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016367-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016367-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016367-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016367-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016367-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016367-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016367-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016367-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016367-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016367-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016367-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016367-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016367-002	AP	1	`3a93d1ddd44b…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	DEXTROSE	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018080-001	AP

Observed Orange Book product history#

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-10-15 13:18:30	2026-09	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 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	N018080-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018080-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018080-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018080-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018080-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018080-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018080-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018080-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018080-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018080-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018080-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018080-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018080-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018080-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018080-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018080-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018080-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018080-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018080-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018080-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018080-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018080-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018080-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018080-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018080-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018080-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018080-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018080-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018080-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018080-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018080-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018080-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018080-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018080-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018080-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018080-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018080-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018080-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018080-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018080-001	AP	1	`3a93d1ddd44b…`

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	DEXTROSE MONOHYDRATE	ICU Medical, Inc.	8b25b7e0-703e-4b43-a4eb-52863511602d	2025-11-02	Warnings, Adverse reactions	Exact identifier ndc (package): 0990-7922-09 ndc (package): 0990-7922-53 ndc (package): 0990-7922-02 ndc (package): 0990-7922-03 ndc (package): 0990-7930-09 ndc (package): 0990-7922-61 ndc (package): 0990-7923-37 ndc (package): 0990-7923-13 ndc (package): 0990-7923-36 ndc (package): 0990-7923-20 ndc (package): 0990-7922-55 ndc (package): 0990-7930-02 ndc (package): 0990-7923-23 ndc (package): 0990-7930-03 ndc (product): 0990-7923 ndc (product): 0990-7922 ndc (product): 0990-7930 ndc11 (package): 00990793009 ndc11 (package): 00990792323 ndc11 (package): 00990792209 ndc11 (package): 00990792336 ndc11 (package): 00990792255 ndc11 (package): 00990792253 ndc11 (package): 00990792261 ndc11 (package): 00990792202 ndc11 (package): 00990792320 ndc11 (package): 00990792337 ndc11 (package): 00990793003 ndc11 (package): 00990793002 ndc11 (package): 00990792313 ndc11 (package): 00990792203 spl id: 06e4d957-1a56-4adb-a42b-fe0773b2fa97 spl set id: 8b25b7e0-703e-4b43-a4eb-52863511602d

Reported adverse events (FAERS/openFDA)#

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