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Dextrose 20 g/100mL Injection, Solution — NDC 00990-7935-19 package photo
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Dextrose 20 g/100mL Injection, Solution — NDC 0990-7935-19 (Billing 00990-7935-19)

by ICU Medical Inc. · 12 POUCH in 1 CASE / 1 BAG in 1 POUCH / 500 mL in 1 BAG

This is a package of Dextrose 20 g/100mL Injection, Solution from ICU Medical Inc., marketed since Oct 2019 and currently FDA-listed. It is this product's only package size.

NDC 00990-7935-19
🏷️ FDA NDC (as labeled) 0990-7935-19 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Dextrose (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 2, 2026 — Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. (B BRAUN MEDICAL INC) · FDA recall D-0496-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0990-7935-19
Product NDC 0990-7935
11-digit billing NDC 00990793519
NCPDP billing unit ML — per mL (volume)
RxCUI 237649, 237650, 237656, 242694, 1795518
UNII LX22YL083G
Application # NDA018564
SPL Set ID b5cb7a5a-bbe8-4217-a82e-da818f7771c9
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-10-01
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance DEXTROSE MONOHYDRATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 80100020002025
GPI class Dextrose
GCN Seq No 001980
GCN 06690
HICL code 000919
Ingredient (HICL) Dextrose 20 % In Water
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C5
Therapeutic class — intermediate (HIC2) Carbohydrates And/Or Proteins
HIC3 code C5J
Therapeutic class — specific (HIC3) Iv Solutions: Dextrose-Water
AHFS code 40:20.00.00
AHFS class Caloric Agents
FDB label name DEXTROSE 20%-WATER IV SOLN
FDB brand name Dextrose In Water
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 001980
  • GCN: 06690
  • GPI-14 (Medi-Span): 80100020002025
  • HICL (First Databank): 000919
  • AHFS class code: 40:20.00.00
  • RxCUI (RxNorm): 237649
Why two NDCs? The FDA registers this code as 0990-7935-19 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00990-7935-19. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Other irrigating solutions class.

Drug family (ATC) Other irrigating solutions, Tests for diabetes, Carbohydrates
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name DEXTROSE 20%-WATER IV SOLN Ingredient Dextrose 20 % In Water
📗 Our plain-language guide HelloPharmacist
  • Dextrose is essentially the same glucose your body gets from food, but in this case it's going directly into the bloodstream. That's important in two main situations: when blood su...
  • Why is my loved one being given dextrose through an IV — isn't sugar just food?
  • Yes, that's a real concern. Dextrose raises blood glucose, which is exactly what you need when blood sugar is too low. But if it's given too fast or in too high a concentration, it...
  • Can dextrose actually cause high blood sugar? I thought it was for low blood sugar.
📖 Read our full Dextrose guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.0308 $184.80 / 6000 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J7799 No ASP payment limit on file for J7799 this quarter.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)0990-7935-19
11-digit billing NDC00990-7935-19
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ7799
DescriptorNOC DRUGS, OTHER THAN INHALATION DRUGS, ADMINISTERED THROUGH DME
Billing units / pkg1 units
How the units are derivedThis package is 500 ML; the HCPCS unit is 1 EA, so one package = 1 billing unit.
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00990-7935-19 You're viewing this Main listing 12 POUCH in 1 CASE / 1 BAG in 1 POUCH / 500 mL in 1 BAG 2019-10-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dextrose 20 g/100mLthis 00990-7935-19 ICU 12 pouches — — FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2019
On the market since
Oct 2019
📍
2026
Currently FDA-listed
7 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

1 inactive ingredient listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerICU Medical Inc.
Application holderOTSUKA ICU MEDICAL LLC
FDA applicationNDA018564 (NDA)
Labeler code00990
First marketedOct 2019
Product typeHuman Prescription Drug
Portfolio48 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 87 words ▾

1 INDICATIONS AND USAGE Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient or contraindicated ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Must be diluted with compatible intravenous fluids or used as admixture, prior to administration. Not for direct intravenous infusion . ( 2.1 ) • Only for slow intravenous infusion only into a: ( 2.1 ) o Central vein , if final dextrose concentration is greater than 5% or osmolality is greater than 900 mOsm/L o Peripheral vein , if final dextrose concentration 5% or less and osmolality is less than 900 mOsm/L • Individualize dosage based on the patient's clinical condition, body weight, nutritional/fluid requirements, as well as additional energy given orally/enterally ( 2.2 ) • Discontinue infusion of concentrated dextrose solutions slowly and/or administer 5% dextrose ( 2.3 )

2.1Important Preparation and Administration Instructions Dextrose Injection is supplied in the following five strengths: 20%, 30%, 40%, 50% and 70% [see How Supplied/Storage and Handling ( 16 )] . Prior to administration, Dextrose Injection must be diluted with other compatible intravenous fluids or used as an admixture with amino acids. It is not for direct intravenous infusion .

Preparation Prior to Administration • Because additives may be incompatible, evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. Consult with a pharmacist, if available. If it is deemed advisable to introduce additives, use aseptic technique and mix thoroughly. • Inspect Dextrose Injection to ensure precipitates have not formed during the mixing or addition of additives.

Discard the bag if precipitates are observed. Some opacity of the plastic container (due to moisture absorption during sterilization process) may be observed. This is normal and does not affect the solution quality or safety.

The opacity will diminish gradually. • Use promptly after admixing or dilution. • For single use only; discard unused portion Important Administration Instructions • Set the vent to the closed position on a vented intravenous administration set to prevent air embolism. • Use a dedicated line without any connections to avoid air embolism. • Prior to infusion, visually inspect the diluted dextrose solution for particulate matter. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear and container is undamaged. • The choice of a central or peripheral venous route of infusion should depend on the osmolarity of the final infusate.

Solutions with greater than 5% dextrose or with osmolarity of greater than or equal to 900 mOsm/L must be infused through a central catheter [see Warnings and Precautions ( 5.5 )] .

2.2Dosing Information Caution: Dextrose Injection is not for direct intravenous infusion. Prior to administration, Dextrose Injection must be diluted with other compatible intravenous fluids or used as an admixture with amino acids. Individualize the dosage of Dextrose Injection based on the patient's clinical condition (ability to adequately metabolize dextrose), body weight, nutritional and fluid requirements, as well as additional energy given orally or enterally to the patient.

The administration rate should be governed, especially during the first few day of therapy, by the patient's tolerance to dextrose. Daily intake of amino acids and dextrose should be increased gradually to the maximum required dose as indicated by frequent determinations of blood glucose levels.

2.3Discontinuation of Dextrose Injection To reduce the risk of hypoglycemia, a gradual decrease in flow rate in the last hour of infusion should be considered.

💊 Dosage Forms and Strengths 173 words ▾

3 DOSAGE FORMS AND STRENGTHS Dextrose Injection 20%, 30%, 40%, 50%, and 70% USP are sterile, non-pyrogenic, hypertonic solutions of dextrose in single-dose, partial-fill, flexible containers. 500 mL fill volume in 1000 mL flexible container • 20% (0.2 grams/mL): 20 grams of dextrose hydrous per 100 mL • 30% (0.3 grams/mL): 30 grams of dextrose hydrous per 100 mL • 40% (0.4 grams/mL): 40 grams of dextrose hydrous per 100 mL • 50% (0.5 grams/mL): 50 grams of dextrose hydrous per 100 mL • 70% (0.7 grams/mL): 70 grams of dextrose hydrous per 100 mL Injection: Single-dose, partial-fill, flexible containers with ( 3 ): 500 mL fill volume in 1000 mL flexible container: • 20% (0.2 grams/mL): 20 grams of dextrose hydrous per 100 mL • 30% (0.3 grams/mL): 30 grams of dextrose hydrous per 100 mL • 40% (0.4 grams/mL): 40 grams of dextrose hydrous per 100 mL • 50% (0.5 grams/mL): 50 grams of dextrose hydrous per 100 mL • 70% (0.7 grams/mL): 70 grams of dextrose hydrous per 100 mL

⛔ Contraindications 53 words ▾

4 CONTRAINDICATIONS The use of Dextrose Injection is contraindicated in patients: • who are severely dehydrated as hypertonic dextrose solution can worsen the patient's hyperosmolar state. • with known hypersensitivity to dextrose [see Warnings and Precautions (5.2) ] . • Severe dehydration ( 4 ) • Known hypersensitivity to dextrose ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Hyperglycemia or Hyperosmolar Hyperglycemic State : Monitor blood glucose and administer insulin as needed ( 5.1 ) • Hypersensitivity Reactions : Monitor for signs and symptoms and discontinue infusion if reactions occur ( 5.2 ) • Risk of Infection : Monitor for signs and symptoms and laboratory parameters ( 5.3 ) • Refeeding Syndrome : Monitory laboratory parameters ( 5.4 ) • Vein Damage and Thrombosis : Administer solutions containing more than 5% dextrose as the final concentration or solutions with an osmolarity ≥ 900 mOsm/L through a central vein ( 2.1 , 5.5 ) • Aluminum Toxicity : Dextrose Injection contains aluminum that may be toxic.

Patients with impaired renal function, and preterm infants, at higher risk. Limit aluminum to less than 4 mcg/kg/day ( 5.6 , 8.4 ) • Parenteral Nutrition Associated Liver Disease : increased risk in patients who receive parenteral nutrition for extended periods of time, especially preterm infants; monitor liver function tests, if abnormalities occur consider discontinuation or dosage reduction. ( 5.7 , 8.4 ) • Electrolyte Imbalance and Fluid Overload : monitor daily fluid balance, blood electrolyte levels, correct as needed.

( 5.8 , 8.4 )

5.1Hyperglycemia and Hyperosmolar Hyperglycemic State The use of dextrose infusions in patients with diabetes mellitus or 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. Patients with underlying confusion 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 optimum levels while administering Dextrose Injection. Insulin may be administered or adjusted to maintain optimal blood glucose levels during Dextrose Injection administration.

5.2Hypersensitivity Reactions Hypersensitivity reactions including anaphylaxis have been reported with dextrose infusions. Stop infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity reaction develop. Signs or symptoms may include: tachypnea, dyspnea, hypoxia, bronchospasm, tachycardia, hypotension, cyanosis, vomiting, nausea, headache, sweating, dizziness, altered mentation, flushing, rash, urticaria, erythema, pyrexia, and chills.

5.3Risk of Infections Patients who require parenteral nutrition are at high risk of infections because the nutritional components of these solutions can support microbial growth. The risk of infection is increased in patients with malnutrition-associated immunosuppression, hyperglycemia exacerbated by dextrose infusion, long-term use and poor maintenance of intravenous catheters, or immunosuppressive effects of other concomitant conditions, drugs, or other components of the parenteral formulation (e.g., lipid emulsion).

To decrease the risk of infectious complications, ensure aseptic technique in catheter placement and maintenance, as well as aseptic technique in the preparation and administration of the nutritional formula. Monitor for signs and symptoms (including fever and chills) of early infections, including laboratory test results (including leukocytosis and hyperglycemia) and frequent checks of the parenteral access device and insertion site for edema, redness and discharge.

5.4Refeeding Syndrome Refeeding severely undernourished patients may result in refeeding syndrome, characterized by the intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop. To prevent these complications, monitor severely undernourished patients and slowly increase nutrient intakes.

5.5Vein Damage and Thrombosis Dextrose Injection is for admixture with amino acids or dilution with other compatible intravenous fluids. It is not for direct intravenous infusion. Administer solutions containing more… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 196 words ▾

6 ADVERSE REACTIONS The following adverse reactions from voluntary reports or clinical studies have been reported with Dextrose Injection. Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. • Hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions ( 5.1 )] . • Hypersensitivity reactions [see Warnings and Precautions ( 5.2 )] . • Risk of infections [see Warnings and Precautions ( 5.3 )] . • Refeeding syndrome [see Warnings and Precautions ( 5.4 )] . • Vein damage and thrombosis [see Warnings and Precautions ( 5.5 )] . • Aluminum toxicity [see Warnings and Precautions ( 5.6 )] . • Risk of parenteral nutrition associated liver disease [see Warnings and Precautions ( 5.7 )] . • Electrolyte imbalance and fluid overload [see Warnings and Precautions ( 5.8 )] .

The most common adverse reactions are hyperosmolar syndrome, infection both systemic and at the injection site, vein thrombosis or phlebitis, and hypervolemia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact ICU Medical, Inc. at 1-800-441-4100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Pediatric Use: Increased risk of hypoglycemia/hyperglycemia; monitor serum glucose concentrations. ( 8.4 )

8.1Pregnancy Risk Summary There are no data with Dextrose Injection in pregnant women. In addition, animal reproduction studies have not been conducted with dextrose. 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.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Consider parenteral nutrition in cases of severe maternal malnutrition where nutritional requirements cannot be fulfilled by the enteral route because of the risks to the fetus associated with severe malnutrition, including preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations, and perinatal mortality.

8.2Lactation There are no data regarding the presence of dextrose in human milk, the effects 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 Injection and any potential adverse effects on the breastfed infant from Dextrose Injection or from the underlying maternal condition.

8.4Pediatric Use Neonates, especially those born premature and with low birth weight are at increased risk of developing hypo – or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose infusions to ensure adequate glycemic control in order to avoid potential long term adverse effects. Hypoglycemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycemia has been associated with intraventricular hemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged length of hospital stay, and death.

Plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes. In very low birth weight infants, excessive or rapid administration of Dextrose Injection may result in increased serum osmolality and possible intracerebral hemorrhage. Because of immature renal function, preterm infants receiving prolonged treatment with Dextrose Injection, may be at risk aluminum toxicity [see Warnings and Precautions ( 5.6 )] .

Patients, including pediatric patients, may be at risk for Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions ( 5.7 )] .

8.5Geriatric Use Clinical studies of Dextrose Injection did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from other younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

🤰 Pregnancy 104 words ▾

8.1Pregnancy Risk Summary There are no data with Dextrose Injection in pregnant women. In addition, animal reproduction studies have not been conducted with dextrose. 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.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Consider parenteral nutrition in cases of severe maternal malnutrition where nutritional requirements cannot be fulfilled by the enteral route because of the risks to the fetus associated with severe malnutrition, including preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations, and perinatal mortality.

🧒 Pediatric Use 183 words ▾

8.4Pediatric Use Neonates, especially those born premature and with low birth weight are at increased risk of developing hypo – or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose infusions to ensure adequate glycemic control in order to avoid potential long term adverse effects. Hypoglycemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycemia has been associated with intraventricular hemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged length of hospital stay, and death.

Plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes. In very low birth weight infants, excessive or rapid administration of Dextrose Injection may result in increased serum osmolality and possible intracerebral hemorrhage. Because of immature renal function, preterm infants receiving prolonged treatment with Dextrose Injection, may be at risk aluminum toxicity [see Warnings and Precautions ( 5.6 )] .

Patients, including pediatric patients, may be at risk for Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions ( 5.7 )] .

🧓 Geriatric Use 45 words ▾

8.5Geriatric Use Clinical studies of Dextrose Injection did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from other younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

🆘 Overdosage 97 words ▾

10 OVERDOSAGE An increased infusion rate of Dextrose Injection or administration of a concentrated dextrose solution can cause hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance [see Warnings and Precautions ( 5.1 , 5.8 )] . Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal. Discontinue infusion and institute appropriate corrective measures in the event of overhydration or solute overload during therapy, with particular attention to respiratory and cardiovascular systems .

For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org .

🧬 Clinical Pharmacology 28 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Dextrose Injection is used to supplement nutrition by providing glucose parenterally. Dextrose is oxidized to carbon dioxide and water, yielding energy.

🧬 Mechanism of Action 25 words ▾

12.1Mechanism of Action Dextrose Injection is used to supplement nutrition by providing glucose parenterally. Dextrose is oxidized to carbon dioxide and water, yielding energy.

📦 How Supplied / Storage and Handling 171 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Dextrose Injection, 20%, 30%, 40%, 50%, and 70% USP are sterile hypertonic solutions of dextrose supplied in single-dose, partial-fill flexible containers (see Tables 1 and 2 ) for intravenous administration after appropriate admixture or dilution [see Dosage and Administration ( 2.1 )] . Do not remove container from the overwrap until intended for use. Table 2: Strengths, Fill Volume, and NDC # of Dextrose Injection 20%, 30%, 40%, 50%, and 70% Strength Fill Volume NDC# 20% (0.2 grams/mL) 500 mL 0409-7935-19 0990-7935-19 30% (0.3 grams/mL) 500 mL 0409-8004-15 0990-8004-15 40% (0.4 grams/mL) 500 mL 0409-7937-19 0990-7937-19 50% (0.5 grams/mL) 500 mL 0409-7936-19 0990-7936-19 70% (0.7 grams/mL) 500 mL 0409-7918-19 0990-7918-19 ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code.

Both NDC codes are expected to be in the market for a period of time. Use the product immediately after mixing and the introduction of additives. Store between 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.] Do not freeze.

📋 Description ~1 min read ▾

11 DESCRIPTION Dextrose Injection, USP 20%, 30%, 40%, 50% and 70% are sterile, nonpyrogenic, hypertonic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after appropriate admixture or dilution [see Dosage and Administration ( 2.1 )] . Partial-fill containers, designed to facilitate admixture or dilution to provide dextrose in various concentrations, are available in various sizes. See Table 1 for the content and characteristics of these concentrated solutions .

The solutions contain no bacteriostatic, antimicrobial agent or added buffer and are intended only for use as a single-dose injection following admixture or dilution. The pH is 4.3 (range is 3.2 to 6.5). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly.

Table 1. Contents and Characteristics of Dextrose Injection 20%, 30%, 40%, 50%, and 70% Strength Fill Volume Amount of Dextrose Hydrous per Container kcal Caloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous. per Container mOsmol per liter 20% (0.2 grams/mL) 500 mL 100 grams 340 1009 30% (0.3 grams/mL) 500 mL 150 grams 510 1514 40% (0.4 grams/mL) 500 mL 200 grams 680 2018 50% (0.5 grams/mL) 500 mL 250 grams 850 2523 70% (0.7 grams/mL) 500 mL 350 grams 1190 3532 Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water.

The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula: Dextrose may be derived from corn. Water for Injection, USP is chemically designated H 2 O.

Dextrose Injection contains no more than 25 mcg/L of aluminum. Structural Formula for Dextrose Injection, USP

💬 Information for Patients 111 words ▾

17 PATIENT COUNSELING INFORMATION Inform patients, caregivers, or home healthcare providers of the following risks of Dextrose Injection: • Hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions ( 5.1 )] • Hypersensitivity reactions [see Warnings and Precautions ( 5.2 )] • Risk of infection [see Warnings and Precautions ( 5.3 )] • Vein damage and thrombosis [see Warnings and Precautions ( 5.5 )] • Aluminum toxicity [see Warnings and Precautions ( 5.6 )] • Risk of parenteral nutrition associated liver disease [see Warnings and Precautions ( 5.7 )] • Fluid overload and electrolyte imbalance [see Warnings and Precautions ( 5.8 )] EN-4695 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

📄 Package Label / Principal Display Panel ~3 min read ▾

PRINCIPAL DISPLAY PANEL - 70 g/100 mL Bag Label 500 mL NDC 0990-7918-19 DEXTROSE INJECTION, USP 70% IN 1000 mL PARTIAL-FILL CONTAINER EACH 100 mL CONTAINS DEXTROSE, HYDROUS, USP 70 g IN WATER FOR INJECTION. HYPERTONIC OSMOLARITY 3532 mOsmol/LITER (calc). pH 4.3 (3.2 to 6.5) SPECIFIC GRAVITY 1.236 CAUTION: HYPERTONIC. ADMINISTER ONLY AFTER DILUTION VIA CENTRAL VENOUS CATHETER.

STERILE, NONPYROGENIC. SINGLE DOSE CONTAINER. DOSAGE AND ADMINISTRATION: SEE PACKAGE INSERT.

CAUTION: DO NOT USE UNLESS SOLUTION IS CLEAR, CLOSURE IS INTACT, AND CONTAINER IS UNDAMAGED. CHECK FOR MINUTE LEAKS BY SQUEEZING FIRMLY. IF LEAKS ARE FOUND DISCARD CONTAINER AND CONTENTS AS STERILITY MAY BE IMPAIRED.

MUST NOT BE USED IN SERIES CONNECTIONS. ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE.

WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C/77°F). AVOID EXCESSIVE HEAT.

PROTECT FROM FREEZING. Rx ONLY IM-4402 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA 3 v CONTAINS DEHP 70% icu medical PPRINCIPAL DISPLAY PANEL - 70 g/100 mL Bag Label

PRINCIPAL DISPLAY PANEL - 70 g/100 mL Bag Overwrap TO OPEN — TEAR AT NOTCH The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap until ready for use. Visually inspect overwrap for tears or holes.

Discard unit if overwrap is damaged. Use unit promptly when pouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

See insert. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired.

Rx only WR-0551 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icu medical PRINCIPAL DISPLAY PANEL - 70 g/100 mL Bag Overwrap

PRINCIPAL DISPLAY PANEL - 20 g/100 mL Bag Label 500 mL IN 1000 mL PARTIAL-FILL CONTAINER NDC 0990-7935-19 20% DEXTROSE Injection, USP EACH 100 mL CONTAINS DEXTROSE, HYDROUS 20 g IN WATER FOR INJECTION. 1009 mOsmol/LITER (CALC.) pH 4.3 (3.2 to 6.5) CAUTION: HYPERTONIC. ADMINISTER ONLY AFTER DILUTION.

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 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 icu medical IM-4404 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA PRINCIPAL DISPLAY PANEL - 20 g/100 mL Bag Label

PRINCIPAL DISPLAY PANEL - 20 g/100 mL Bag Overwrap TO OPEN — TEAR AT NOTCH The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap until ready for use. Visually inspect overwrap for tears or holes.

Discard unit if overwrap is damaged. Use unit promptly when pouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

See insert. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired.

Rx only WR-0552 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icu medical PRINCIPAL DISPLAY PANEL - 20 g/100 mL Bag Overwrap

PRINCIPAL DISPLAY PANEL - 50 g/100 mL Bag Label 500 mL NDC 0990-7936-19 DEXTROSE INJECTION, USP 50% IN 1000 mL PARTIAL-FILL CONTAINER EACH 100 mL CONTAINS DEXTROSE, HYDROUS, USP 50 g IN WATER FOR INJECTION. HYPERTONIC OSMOLARITY 2523 mOsmol/LITER (calc). pH 4.3 (3.2 to 6.5) SPECIFIC GRAVITY 1.170 CAUTION: HYPERTONIC. ADMINISTER ONLY AFTER DILUTION VIA CENTRAL VENOUS CATHETER.

STERILE, NONPYROGENIC. SINGLE DOSE CONTAINER. DOSAGE AND ADMINISTRATION: SEE PACKAGE INSERT.

CAUTION: DO NOT USE UNLESS SOLUTION IS CLEAR, CLOSURE IS INTACT, AND CONTAINER IS UNDAMAGED. CHECK FOR MINUTE… [Excerpted — this section continues on DailyMed.]

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
133
Units reimbursed last 4 qtrs
1M
Gross reimbursed last 4 qtrs
$31.9K
Avg / prescription
$240.05
Avg / unit
$0.0308
Latest quarter Q1 2026
30Rx
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 133 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 866,500 units · 2,224 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 170,000 units · 1,569 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
1,5692,224
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 California 2,224 /100k
2 North Carolina 1,569 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by ICU Medical Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
ICU Medical Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J7799 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00990-7930-02 · ICU 00990-7936-19 · ICU →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.