HomeNDC LookupIngredientsDextrose Monohydrate › 00990-7930-02
Dextrose 10 g/100mL Injection, Solution — NDC 00990-7930-02 package photo

Dextrose 10 g/100mL Injection, Solution

by ICU Medical, Inc. · 24 POUCH in 1 CASE (0990-7930-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG
NDC 00990-7930-02
🏷️ FDA NDC (as labeled) 0990-7930-02 billing pads the labeler segment with a zero
This package
Contains250 mL in 1 bag Medicaid pays$0.0210 / unit · 12 mo Per package$126.00 / 6000 ml · Medicaid Pack sizes3 compare ↓
Also priced by: Part D plans $0.0214/unit — full pricing hub ↓
Rx only Brand On market Non-controlled ⚠ On shortage
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Active FDA shortage. Dextrose Monohydrate 10% Injection is currently reported in shortage by the FDA. Available Shortage details →
⚠️
Other active recalls for Dextrose Monohydrate (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0435-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0437-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0436-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 0990-7930-02
Product NDC 0990-7930
11-digit billing NDC 00990793002
NCPDP billing unit ML — per mL (volume)
UNII LX22YL083G
Application # NDA018080
SPL Set ID 8b25b7e0-703e-4b43-a4eb-52863511602d
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-07-15
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance DEXTROSE MONOHYDRATE
GPI-14 80100020002020
GPI class Dextrose
GCN Seq No 001978
GCN 06671
HICL code 000918
Ingredient (HICL) Dextrose 10 % 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 10%-WATER IV SOLUTION
FDB brand name Dextrose In Water
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 0990-7930-02 — 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 → 00990-7930-02. 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.

🏭 Manufacturer & labeler

LabelerICU Medical, Inc.
Application holderOTSUKA ICU MEDICAL LLC
FDA applicationNDA018080 (NDA)
Labeler code00990
First marketedJul 2019
Product typeHuman Prescription Drug
Portfolio5 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.

🩺 Clinical

Label name DEXTROSE 10%-WATER IV SOLUTION Ingredient Dextrose 10 % In Water
📗 Our plain-language guide HelloPharmacist
  • Dextrose is essentially glucose — sugar — given directly into a vein. In an emergency, it's used to quickly raise dangerously low blood sugar, which can happen with too much insuli...
  • Specific formulations — Infant Dextrose (25%) and Dextrose (25% injection) — are FDA-approved to treat low blood sugar in newborns and infants up to 2 years old. That said, prematu...
  • Is dextrose safe for my baby or newborn?
  • The most common issues are high blood sugar, vein irritation or clotting at the IV site, low sodium in the blood, and infection. More serious — but less common — reactions include...
📖 Read our full Dextrose guide →
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.

🧪 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 DailyMedingredient 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.

💲 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 $0.0210 $126.00 / 6000 ml
Medicare drug plans payPart D · Q2 2026 $0.0214 $128.40 / 6000 ml
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)0990-7930-02
11-digit billing NDC00990-7930-02
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
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dextrose 10 g/100mL 00990-7938-19 ICU 12 pouches AP FDA listed
Dextrose 10 g/100mLthis 00990-7930-02 ICU 24 pouches AP 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
Jul 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.

🗺️ 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 00990-7930-02, 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 – Q4 2025 · 4 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
71
Units reimbursed last 4 qtrs
18.3K
Gross reimbursed last 4 qtrs
$383.25
Avg / prescription
$5.40
Avg / unit
$0.0210
Latest quarter Q4 2025
18Rx
Fee-for-service vs managed care
100% FFS
Fee-for-service · 71 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: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 18,250 units · 295 per 100k residents 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: no data reported 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
295295
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 Missouri 295 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
Drug total (last 4 qtrs): 234 Rx · 92,401 units · $2,063 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00990-7930-02 You're viewing this 24 POUCH in 1 CASE (0990-7930-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG 2019-08-01 Active
00990-7930-03 24 POUCH in 1 CASE (0990-7930-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG 2019-08-01 Active
00990-7930-09 12 POUCH in 1 CASE (0990-7930-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG 2019-08-01 Active

This pack accounts for about 30% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 00990-7930-02?
NDC 00990-7930-02 is listed by the FDA — 24 pouch in 1 case / 1 bag in 1 pouch / 250 ml in 1 bag.
What NDC number is used to bill for this package of Dextrose 10 g/100mL Injection, Solution?
Bill NDC 00990-7930-02 — the 11-digit billing format is 00990793002. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 ✓ Available
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 FDA registers it as 0990-7930-02, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00990-7930-02, written without dashes as 00990793002. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00990-7930-02, the first segment (00990) is the labeler code FDA assigned to ICU Medical, Inc.; the middle segment (7930) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 12 pouches (00990-7930-09), 24 pouches (00990-7930-03). Each has its own NDC and its own page — see the package list near the top of this page.
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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 79 words

1 INDICATIONS AND USAGE Dextrose Injection (5% and 10%) is indicated as a source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product. 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. ( 1 )

⏱️ Dosage and Administration ~3 min read

2 DOSAGE AND ADMINISTRATION Only for intravenous infusion. ( 2.1 ) Infusion rate depends on the age, weight, clinical and metabolic conditions of the patient and concomitant therapy. See full prescribing information for more information on preparation, administration, and dosing considerations. ( 2.1 , 2.2 , 2.3 )

2.1Important Administration Instructions Dextrose Injection (5% and 10%) is intended for intravenous use. Use a peripheral vein to administer if the final dextrose concentration is 5% or less and the osmolarity is less than 900 mOsm/L. Consider using a central vein to administer hypertonic solutions with osmolarity of 900 mOsm/L or greater to avoid venous irritation [see Warnings and Precautions (5.3) ] .

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.

2.2Important Preparation Information Visually inspect the Dextrose Injection (5% and 10%) for particulate matter and discoloration. Do not administer Dextrose Injection (5% and 10%) if the solution is cloudy, there are precipitates, or the container is damaged. To reduce the risk of air embolism, adhere to the following preparation instructions for Dextrose Injection (5% and 10%): Use a non-vented infusion set or close the vent on a vented set.

Use a dedicated line without any connections (do not connect flexible containers in series). Do not pressurize the flexible container to increase flow rates. If using a pumping device to administer Dextrose Injection (5% and 10%), turn off the pump before the container is empty.

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

2.3Dosage Considerations The choice of dextrose concentration, rate, and volume depends on the age, weight, clinical and metabolic conditions of the patient and concomitant therapy. Dextrose Injection (5% and 10%) administration rate should be based on the patient's tolerance of dextrose, especially for 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) ] .

💊 Dosage Forms and Strengths 123 words

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

( 3 ) 10% (10 g/100 mL) (100 mg/mL) of dextrose hydrous in single-dose flexible containers: 250 mL, 500 mL, and 1000 mL. ( 3 )

Contraindications 46 words

4 CONTRAINDICATIONS Dextrose Injection (5% and 10%) is contraindicated in patients with: Clinically significant hyperglycemia [see Warnings and Precautions (5.2) ] . Known hypersensitivity to dextrose [see Warnings and Precautions (5.3) ] . Clinically significant hyperglycemia. ( 4 ) Known hypersensitivity to dextrose. ( 4 )

⚠️ Warnings and Cautions ~3 min read

5 WARNINGS AND PRECAUTIONS Neonatal Hypoglycemia : Closely monitor blood glucose concentrations to ensure adequate glycemic control. ( 5.1 ) Hyperglycemia and Hyperosmolar Hyperglycemic State : Use with caution in patients with known subclinical or overt diabetes mellitus. ( 5.2 ) Hypersensitivity Reactions: Monitor for signs and symptoms and discontinue infusion immediately if reaction occurs.

( 5.3 ) Phlebitis and Thrombosis : Remove catheter as soon as possible if thrombophlebitis develops. ( 2.1 , 5.4 ) Hyponatremia : Monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and neurologic status. ( 5.5 ) Electrolyte Imbalance and Fluid Overload : Monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during administration.

( 5.6 ) Refeeding Syndrome : Monitor laboratory parameters. ( 5.7 )

5.1Neonatal Hypoglycemia Neonates, especially preterm neonates with low birth weight, are at increased risk of developing hypoglycemia. Closely monitor blood glucose concentration during treatment with Dextrose Injection (5% and 10%) to ensure adequate glycemic control in order to avoid potential long-term adverse effects.

5.2Hyperglycemia and Hyperosmolar Hyperglycemic State The use of Dextrose Injection (5% and 10%) in patients with impaired glucose tolerance may worsen hyperglycemia. Administration of dextrose at a rate exceeding the patient's utilization rate may lead to hyperglycemia, coma, and death. Hyperglycemia is associated with an increase in serum osmolality, resulting in osmotic diuresis, dehydration and electrolyte losses [see Warnings and Precautions (5.6) , Use in Specific Populations (8.4) ] .

Patients with underlying CNS disease and renal impairment who receive dextrose infusions may be at greater risk of developing hyperosmolar hyperglycemic state. Monitor blood glucose levels and treat hyperglycemia to maintain levels within normal limits while administering Dextrose Injection (5% and 10%). Insulin may be administered or adjusted to maintain optimal blood glucose levels during Dextrose Injection (5% and 10%) administration.

5.3Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, have been reported with Dextrose Injection (5% and 10%) administration [see Adverse Reactions (6) ] . Stop administration of Dextrose Injection (5% and 10%) immediately if signs or symptoms of a hypersensitivity reaction develop. Initiate appropriate treatment as clinically indicated.

5.4Phlebitis and Thrombosis The infusion of hypertonic solutions into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis [see Dosage and Administration (2.1) ] . If thrombophlebitis develops, remove the catheter as soon as possible.

5.5Hyponatremia 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) ] .

5.6Electrolyte Imbalance and Fluid Overload Electrolyte deficits, particularly serum potassium and phosphate, may occur during prolonged use of Dextrose Injection (5% and 10%). Depending on the administered volume and the infusion rate, Dextrose Injection (5% and 10%) can cause fluid o…

🤒 Adverse Reactions 202 words

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Neonatal Hypoglycemia [see Warnings and Precautions (5.1) ] Hyperglycemia and Hyperosmolar Hyperglycemic State [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Phlebitis and Thrombosis [see Warnings and Precautions (5.4) ] Hyponatremia [see Warnings and Precautions (5.5) ] Electrolyte Imbalance and Fluid Overload [see Warnings and Precautions (5.6) ] Refeeding syndrome [see Warnings and Precautions (5.7) ] The following adverse reactions associated with the use of Dextrose Injection (5% and 10%) were identified in clinical studies or postmarketing reports.

Because some of these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Administration site conditions: blister, erythema, extravasation, pain, phlebitis, vein damage, thrombosis Immune system disorders: anaphylaxis, angioedema, bronchospasm, chills, hypotension, pruritis, pyrexia, rash Cardiovascular disorders: cyanosis, volume overload The most common adverse reactions are hyperglycemia, hypersensitivity reactions, hyponatremia, infection, both systemic and at the injection site, vein thrombosis or phlebitis, and electrolyte imbalance.

( 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.

🔄 Drug Interactions 178 words

7 DRUG INTERACTIONS Drugs with Effects on Glycemic Control and Electrolyte Balance : Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations, and acid-base balance. Avoid use of Dextrose Injection in patients receiving drugs associated with hyponatremia. ( 7.1 )

7.1Drugs with Effects on Glycemic Control and Electrolyte Balance Dextrose Injection (5% and 10%) can affect glycemic control, vasopressin, and fluid and/or electrolyte balance [see Warnings and Precautions (5.1 , 5.2 , 5.4 , 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) ] .

👥 Use in Specific Populations ~3 min read

8 USE IN SPECIFIC POPULATIONS Pediatric Use : Increased risk of hypoglycemia/hyperglycemia and imbalances in fluid/electrolytes; monitor serum glucose concentrations, volume status, and electrolytes. ( 8.4 )

8.1Pregnancy 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 .

8.2Lactation 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.

8.4Pediatric Use Dextrose Injection (5% and 10%) is indicated in pediatric patients as a source of water and calories, and may also be used as a diluent for reconstitution of a powder or liquid drug product. Neonates, especially 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.

8.5Geriatric Use Dextrose Injection (5% and 10%) has not been studied in sufficient number of patients aged 65 and over to determine whether they respond differently from younger patients. Geriatric patients are at increased risk of developing hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.5) ] . Other reported clinical experience has not identified differences in responses between the geriatric and younger adult patients.

In general, the infusion rate for geriatric patients should start slow and be titrated up cautiously, reflecting their greater risk for electrolyte abnormalities and fluid overload. Dextrose is known to be substantially excreted by the kidney, and the risk of adverse reactions to Dextrose Injection (5% and 10%) may be greater in patients with impaired renal function. Because geriatric patients are more likely to have impaired renal function, care should be taken in selection of infusion rate and patients should be closely monitored during Dextrose Injection (5% and 10%) treatment.

🤰 Pregnancy 124 words

8.1Pregnancy 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 .

🧒 Pediatric Use 163 words

8.4Pediatric Use Dextrose Injection (5% and 10%) is indicated in pediatric patients as a source of water and calories, and may also be used as a diluent for reconstitution of a powder or liquid drug product. Neonates, especially 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.

🧓 Geriatric Use 156 words

8.5Geriatric Use Dextrose Injection (5% and 10%) has not been studied in sufficient number of patients aged 65 and over to determine whether they respond differently from younger patients. Geriatric patients are at increased risk of developing hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.5) ] . Other reported clinical experience has not identified differences in responses between the geriatric and younger adult patients.

In general, the infusion rate for geriatric patients should start slow and be titrated up cautiously, reflecting their greater risk for electrolyte abnormalities and fluid overload. Dextrose is known to be substantially excreted by the kidney, and the risk of adverse reactions to Dextrose Injection (5% and 10%) may be greater in patients with impaired renal function. Because geriatric patients are more likely to have impaired renal function, care should be taken in selection of infusion rate and patients should be closely monitored during Dextrose Injection (5% and 10%) treatment.

🆘 Overdosage 97 words

10 OVERDOSAGE A medication error resulting in a high infusion rate of Dextrose Injection (5% and 10%) can cause hyperglycemia, hyperosmolality, and adverse effects on fluid and electrolyte balance [see Warnings and Precautions (5.2 , 5.6) ]. Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal. In the event of overdosage (overhydration or solute overload) during Dextrose Injection (5% and 10%) treatment, discontinue the infusion.

Institute corrective measures such as administration of exogenous insulin, and treat adverse effects on the CNS, respiratory, and cardiovascular systems [see Warnings and Precautions (5.2 , 5.6) ] .

🧬 Clinical Pharmacology 57 words

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Dextrose provides a source of carbohydrate calories and is used to supplement nutrition by providing glucose parenterally.

12.2Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of dextrose have not been fully characterized.

12.3Pharmacokinetics Dextrose is oxidized to carbon dioxide and water.

🧬 Mechanism of Action 21 words

12.1Mechanism of Action Dextrose provides a source of carbohydrate calories and is used to supplement nutrition by providing glucose parenterally.

📦 How Supplied / Storage and Handling ~1 min read

16 HOW SUPPLIED/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, Illinois, 60045, USA 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 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.

📦 Storage and Handling 29 words

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.

📋 Description 220 words

11 DESCRIPTION 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: Water for Injection, USP is chemically designated H 2 O.

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. Chemical Structure

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