HomeNDC LookupIngredientsDextrose Monohydrate › 00338-0551-11
Dextrose 5 g/100mL Injection, 50 mL — NDC 00338-0551-11 package photo

Dextrose 5 g/100mL Injection, 50 mL

by Baxter Healthcare Company · 50 mL in 1 BAG (0338-0551-11)
NDC 00338-0551-11
🏷️ FDA NDC (as labeled) 0338-0551-11 billing pads the labeler segment with a zero
This package
Contains50 mL Medicaid pays$0.3330 / unit · 12 mo Per package$0.33 / 1 bag · Medicaid Pack sizes2 compare ↓
Also priced by: Part D plans $0.0214/unit — full pricing hub ↓
Also comes in: 100 ml 00338-0551-18
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 5% 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) 0338-0551-11
Product NDC 0338-0551
11-digit billing NDC 00338055111
NCPDP billing unit ML — per mL (volume)
RxCUI 1795609, 1795616
UNII LX22YL083G
Application # NDA020179
SPL Set ID 7de48bdb-9a05-4f2a-bbff-dcfeb284ca6e
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1992-12-07
Route INTRAVENOUS
Dosage form INJECTION
Substance DEXTROSE MONOHYDRATE
GPI-14 80100020002015
GCN Seq No 060475
GCN 26636
HICL code 000915
Ingredient (HICL) Dextrose 5 % 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 5%-WATER IV SOLN
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 0338-0551-11 — 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 → 00338-0551-11. 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

LabelerBaxter Healthcare Company
Application holderBAXTER HEALTHCARE CORP
FDA applicationNDA020179 (NDA)
Labeler code00338
First marketedDec 1992
Product typeHuman Prescription Drug
Portfolio121 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 5%-WATER IV SOLN Ingredient Dextrose 5 % 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.3330 $0.33 / 1 bag
Medicare drug plans payPart D · Q2 2026 $0.0214 $0.02 / 1 bag
Medicare Part B allowsASP · J7060 $1.649 / J7060 unit
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)0338-0551-11
11-digit billing NDC00338-0551-11
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ7060
Descriptor5% DEXTROSE/WATER (500 ML = 1 UNIT)
Billing units / pkg0 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 5 g/100mL 00990-7923-13 ICU 48 pouches AP FDA listed
Dextrose 5 g/100mL 00338-0176-01 Baxter 100 ml AP FDA listed
Dextrose 5 g/100mL 00338-9655-60 Baxter 100 ml AP FDA listed
Dextrose 5 g/100mL 00990-7922-02 ICU 24 pouches AP FDA listed
Dextrose 5 g/100mL 00338-0070-10 Baxter 1000 ml AP FDA listed
Dextrose 5 g/100mL 00338-0078-20 Baxter 500 ml AP FDA listed
Dextrose 5 g/100mL 00338-0172-01 Baxter 100 ml AP FDA listed
Dextrose 5 g/100mL 00338-9653-60 Baxter 100 ml AP FDA listed
Dextrose 5 g/100mL 00338-0074-30 Baxter 250 ml AP FDA listed
Dextrose 5 g/100mL 00338-0082-10 Baxter 1000 ml AP FDA listed
Dextrose 5 g/100mLthis 00338-0551-11 Baxter 50 ml AP FDA listed
Dextrose 5 g/100mL 00338-0062-30 Baxter 250 ml AP FDA listed
Dextrose 5 g/100mL 00338-0066-20 Baxter 500 ml AP FDA listed
Dextrose 5 g/100mL 00338-0208-04 Baxter 100 ml AP FDA listed
Dextrose 5 g/100mL 00338-0216-04 Baxter 100 ml AP FDA listed
Dextrose 5 g/100mL 00338-9666-35 Baxter 100 ml AP FDA listed
Dextrose 5 g/100mL 00338-9147-30 Baxter 100 ml 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

🏛️
1992
On the market since
Dec 1992
📍
2026
Currently FDA-listed
34 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 00338-0551-11, 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
3.9K
Units reimbursed last 4 qtrs
946.7K
Gross reimbursed last 4 qtrs
$315.3K
Avg / prescription
$80.34
Avg / unit
$0.3330
Latest quarter Q4 2025
797Rx
Fee-for-service vs managed care
44% FFS 56% MCO
Fee-for-service · 1,728 Rx Managed care · 2,196 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: 229,500 units · 4,000 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 379,550 units · 1,939 per 100k residents NY Vermont: no data reported VT New Hampshire: 48,136 units · 3,433 per 100k residents 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: 17,800 units · 142 per 100k residents IL Indiana: 13,400 units · 195 per 100k residents IN Ohio: 127,200 units · 1,079 per 100k residents OH Pennsylvania: no data reported PA New Jersey: 46,350 units · 499 per 100k residents NJ Massachusetts: no data reported MA California: 25,117 units · 64.5 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 29,050 units · 469 per 100k residents MO Kentucky: 389 units · 8.6 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 21,218 units · 343 per 100k residents 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: 9,000 units · 83.1 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
8.64,000
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 Minnesota 4,000 /100k
2 New Hampshire 3,433 /100k
3 New York 1,939 /100k
4 Ohio 1,079 /100k
5 New Jersey 499 /100k
6 Missouri 469 /100k
7 Maryland 343 /100k
8 Indiana 195 /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.
5 ml this page00338-0551-11 3,924 Rx · $315,256
1 ml00338-0551-18 3,219 Rx · $357,685
Drug total (last 4 qtrs): 7,143 Rx · 1,981,262 units · $672,941 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
00338-0551-11 You're viewing this 50 mL in 1 BAG (0338-0551-11) 1992-12-07 Active
00338-0551-18 100 mL in 1 BAG (0338-0551-18) 1992-12-07 Active

You're viewing the smallest of 2 pack sizes for this product.

In Medicaid, this is the most-dispensed pack of this product — about 55% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00338-0551-11?
NDC 00338-0551-11 contains 50 mL — 50 ml in 1 bag.
What is the difference between NDC 00338-0551-11 and NDC 00338-0551-18?
Both are Dextrose 5 g/100mL Injection — the drug itself is identical. NDC 00338-0551-11 is the 50 mL package, while NDC 00338-0551-18 is the 100 ml package.
What NDC number is used to bill for this package of Dextrose 5 g/100mL Injection?
Bill NDC 00338-0551-11 — the 11-digit billing format is 00338055111. 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 0338-0551-11, 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: 00338-0551-11, written without dashes as 00338055111. 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 00338-0551-11, the first segment (00338) is the labeler code FDA assigned to Baxter Healthcare Company; the middle segment (0551) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (11) 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 Baxter Healthcare Company. 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 1 other package presentation of this same product, including 100 ml (00338-0551-18). 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?
Baxter Healthcare Company 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 J7060 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 86 words

1 INDICATIONS AND USAGE Dextrose Injection is indicated as source of water and calories and may also be used as diluent for reconstitution of a powdered or liquid (up to 10 mL) drug product packaged in a vial with a 20 mm closure. Dextrose Injection is indicated as a source of calories and water and may also be used as diluent for reconstitution of a powdered or liquid (up to 10 mL) drug product packaged in a vial with a 20 mm closure. ( 1 )

⏱️ Dosage and Administration ~3 min read

2 DOSAGE AND ADMINISTRATION • Only for intravenous infusion. ( 2.1 ) • See full prescribing information for information on preparation, administration, dosing considerations and instructions for use. ( 2.1 , 2.2 , 2.3 )

2.1Important Administration Instructions • Dextrose Injection is intended for intravenous use. • Peripheral administration of 5% dextrose is generally acceptable, however, consider central vein when administering more than 5% dextrose or with an osmolarity of at least 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain [see Warnings and Precautions (5.3) ] . • Do not administer Dextrose Injection simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis. • To prevent air embolism, use a non-vented infusion set or close the vent on a vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administration, do not pressurize the flexible container to increase flow rates, and if administration is controlled by a pumping device, turn off pump before the container runs dry. • 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. • Use of a final filter is recommended during administration of parenteral solutions, where possible.

2.2Recommended Dosage The choice of dextrose concentration, rate and volume depends on the age, weight, clinical and metabolic conditions of the patient and concomitant therapy. Electrolyte supplementation may be indicated according to the clinical needs of the patient. The administration rate should be governed, especially for premature infants with low birth weight, during the first few days of therapy, by the patient’s tolerance to dextrose.

Increase the infusion rate gradually as indicated by frequent monitoring of blood glucose concentrations [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4) ].

2.3Instructions for Use To Open • Do not remove from overpouch until ready to use. • Tear overwrap sharply down from the slit and remove solution container. Small amounts of moisture may be found on the solution container from water permeating from inside the container. The amount of permeated water is insufficient to affect the solution significantly.

If larger amounts of water are found, the container should be checked for tears or leaks. • Visually inspect the container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety.

The opacity will diminish gradually. Evaluate the following: • If the outlet port protector is damaged, detached, or not present, discard container. • Check to ensure the solution is clear and there are no precipitates. Discard if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals. • Check for minute leaks by separately squeezing the inner bag firmly.

If leaks are found, discard container. • Check that the vial adaptor cover is intact. If the vial adaptor cover is not intact, discard product. Preparation for Administration • Instructions for Assembly and Reconstitution: (Steps 1-3 for Assembly and steps 4-6 for Reconstitution) Step 1: Remove vial cover and disinfect stopper.

Step 2: Peel off foil cover. Inspect adaptor for moisture. Discard if moisture is found.

Step 3: Place vial upright and hold firmly. Push adaptor down until vial snaps in place. DO NOT TWIST.

Pull vial to ensure fully seated. Step 4: Squeeze the bag and check vial. Use only if vial is fully seated and dry.

Bend up then down to break the seal. Step 5: Hold bag with vial down. Squeeze solution into vial until half full.

Shake to suspend drug in solution. Step…

💊 Dosage Forms and Strengths 60 words

3 DOSAGE FORMS AND STRENGTHS Dextrose Injection, USP is a clear, sterile, non-pyrogenic solution of 5 grams of dextrose hydrous per 100 mL (0.05 grams/mL) in 50 mL and 100 mL single-dose, partial-fill flexible containers. Injection: 5% (0.05 grams/mL), 5 grams of dextrose hydrous per 100 mL in 50 mL and 100 mL single-dose, partial-fill flexible containers: ( 3 )

Contraindications 48 words

4 CONTRAINDICATIONS The use of Dextrose Injection is contraindicated in patients with: • Clinically significant hyperglycemia [see Warnings and Precautions (5.1) ]. • Known hypersensitivity to dextrose [see Warnings and Precautions (5.2) ] • Clinically significant hyperglycemia. ( 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 ) • Vein Damage and Thrombosis : Consider central vein when administering more than 5% dextrose or with an osmolarity of ≥ 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain.

( 2.2 , 5.3 ) • Hyponatremia : Avoid in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations ( 5.4 ) • Electrolyte Imbalance and Fluid Overload : Avoid in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor daily fluid balance, electrolyte concentrations, and acid-base balance, as needed and especially during prolonged use ( 5.5 ) • Refeeding Syndrome : Monitor severely undernourished patients and slowly increase nutrient intake.

( 5.6 )

5.1Hyperglycemia and Hyperosmolar Hyperglycemic State The use of dextrose infusions 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 (5.5) ].

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. Insulin may be administered or adjusted to maintain optimal blood glucose levels during Dextrose Injection administration.

5.2Hypersensitivity Reactions Hypersensitivity and infusion reactions including anaphylaxis, have been reported with Dextrose Injection [see Adverse Reactions (6) ] . Stop infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated.

5.3Vein Damage and Thrombosis Peripheral administration of 5% Dextrose Injection is generally acceptable, however, consider central vein when administering more than 5% dextrose or with an osmolarity of ≥ 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain [see Dosage and Administration (2.1) ] . The infusion of hypertonic solutions into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis. The primary complication of peripheral access is venous thrombophlebitis, which manifests as pain, erythema, tenderness or a palpable cord.

Remove the catheter as soon as possible, if thrombophlebitis develops.

5.4Hyponatremia 5% Dextrose Injection is an isotonic solution [see Description, Table 1 (11) ] . In the body, however, glucose containing fluids can become extremely physiologically hypotonic due to rapid glucose metabolization. Monitoring of serum sodium is particularly important for hypotonic fluids.

Depending on the tonicity of the solution, the volume and rate of infusion, and depending on a patient’s underlying clinical condition and capability to metabolize glucose, intravenous administration of glucose can cause electrolyte disturbances, most importantly hypo- or hyperosmotic hyponatremia. Monitor serum sodium to minimize the risk of hyponatremia. The risk for hyponatremia is increased in pediatric patients, elderly patients, postoperative patients, those with psychogenic polydipsia, and in patients treated with medications that increase the risk of hyponatremia (such as diuretics, certain antiepileptic and psychotropic medications).

Close clinical monitoring may be warranted. Acute hyponatremia can lead to acute hyponatremic encephalopathy characterized by head…

🤒 Adverse Reactions 192 words

6 ADVERSE REACTIONS The following adverse reactions associated with the use of dextrose injection were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. The following clinically significant adverse reactions are described elsewhere in the labeling: • Hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions (5.1) ] • Hypersensitivity reactions: anaphylaxis, pruritis, bronchospasm, cyanosis, angioedema, hypotension, pyrexia, chills, and rash [see Warnings and Precautions (5.2) ] • Infusion Site Reactions: infusion site phlebitis, infusion site erythema, vein damage and thrombosis [see Warnings and Precautions (5.3) ] • Hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.4) ] • Refeeding syndrome [see Warnings and Precautions (5.6) ] Electrolyte imbalance, fluid overload and hypervolemia [see Warnings and Precautions (5.5) ] 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 Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 99 words

7 DRUG INTERACTIONS Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance : Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations and acid-base balance. ( 7.1 )

7.1Other Products that Affect Glycemic Control or Fluid and/or Electrolyte Balance Dextrose Injection can affect glycemic control, vasopressin and fluid and/or electrolyte balance [see Warnings and Precautions ( 5.1 , 5.4 , 5.5 )] . Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations and acid-base balance when using Dextrose Injection in patients treated with other substances that affect glycemic control, vasopressin or fluid and/or electrolyte balance.

👥 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 Appropriate administration of Dextrose Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with injectable dextrose solutions. The estimated 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 There are no data on the presence of dextrose in human milk, the effects on a breastfed infant, or the effects on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of Dextrose Injection to an infant during lactation; therefore, 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 The safety profile of Dextrose Injection in pediatric patients is similar to adults. Neonates, especially premature infants 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. Closely monitor plasma electrolyte concentrations in pediatric patients who 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 risk of intracerebral hemorrhage. Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions (5.4) ] .

8.5Geriatric Use Clinical studies of Dextrose Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions (5.4) ] . Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Dextrose is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

🤰 Pregnancy 91 words

8.1Pregnancy Risk Summary Appropriate administration of Dextrose Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with injectable dextrose solutions. The estimated 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 126 words

8.4Pediatric Use The safety profile of Dextrose Injection in pediatric patients is similar to adults. Neonates, especially premature infants 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. Closely monitor plasma electrolyte concentrations in pediatric patients who 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 risk of intracerebral hemorrhage. Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions (5.4) ] .

🧓 Geriatric Use 162 words

8.5Geriatric Use Clinical studies of Dextrose Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions (5.4) ] . Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Dextrose is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

🆘 Overdosage 108 words

10 OVERDOSAGE An increased infusion rate of Dextrose Injection or administration of dextrose solutions can cause hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance [see Warnings and Precautions (5.1 , 5.5) ] . Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal. Discontinue infusion, reduce dose and institute appropriate corrective measures such as administration of exogenous insulin.

Discontinue infusion and institute appropriate corrective measures in the event of overhydration or solute overload during therapy, with particular attention to CNS, respiratory and cardiovascular systems. If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.

🧬 Clinical Pharmacology 16 words

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Dextrose oxidized to carbon dioxide and water, yielding energy.

🧬 Mechanism of Action 13 words

12.1Mechanism of Action Dextrose oxidized to carbon dioxide and water, yielding energy.

📦 How Supplied / Storage and Handling 86 words

16 HOW SUPPLIED/STORAGE AND HANDLING Dextrose Injection 5%, USP is a clear, sterile solutions of dextrose supplied in single-dose, partial-fill flexible containers. Product Description Size Code NDC Dextrose Injection 5%, USP (0.05 grams/mL) 50 mL 2B0040 0338-0551-11 100 mL 2B0041 0338-0551-18 Do not remove container from the overwrap until intended for use. Use the product immediately after mixing and the introduction of additives.

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F).

📋 Description ~2 min read

11 DESCRIPTION Dextrose Injection, 5% USP is a clear, sterile, non-pyrogenicsolutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after admixture with a single dose powdered or liquid (up to 10 mL) drug vial [see Dosage and Administration (2.1) ] . Partial-fill containers, designed to facilitate admixture, are available in 50 mL, and 100 mL sizes. See Table 1 for the content and characteristics of this solution.

The solution contains no bacteriostatic, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. The pH range is 4.0 (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 5%, USP 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 Dextrose Injection 5%, USP (0.05 grams/mL) 50 mL 2.5 grams 8.5 252 100 mL 5 grams 17 252 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 is derived from corn. The MINI-BAG Plus Container is a standard diluent container with an integral drug vial adaptor.

It allows for drug admixture after connection to a single dose powdered or liquid (up to 10 mL) drug vial having a 20 mm closure. A breakaway seal in the tube between the vial adaptor and the container is broken to allow transfer of the diluent into the vial and reconstitution of the drug. The MiniBag Plus product mechanically prohibits the transfer of contaminants into and out of the system during and after docking, minimizing environmental and personal exposure.

The reconstituted drug is then transferred from the vial into the container diluent and mixed to result in an admixture for delivery to the patient. The VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle.

The VIAFLEX Plus plastic container system utilizes the same container as the VIAFLEX plastic container system. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million.

However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies. D-Glucose monohydrate Chemical Structure

💬 Information for Patients 73 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)] • Vein damage and thrombosis [see Warnings and Precautions (5.3)] • Hyponatremia [see Warnings and Precautions (5.4)] • Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.5)] • Refeeding syndrome [see Warnings and Precautions (5.6)]

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.