HomeNDC LookupIngredientsDextrose Monohydrate › 00338-0017-41
DEXTROSE 50 g/1000mL Injection, Solution, 50 mL — NDC 00338-0017-41 package photo

DEXTROSE 50 g/1000mL Injection, Solution, 50 mL

by Baxter Healthcare Corporation · 1 BAG in 1 PACKAGE (0338-0017-41) / 50 mL in 1 BAG
NDC 00338-0017-41
🏷️ FDA NDC (as labeled) 0338-0017-41 billing pads the labeler segment with a zero
This package
Contains50 mL Medicaid pays$0.1569 / unit · 12 mo Per package$7.85 / 50 ml · Medicaid Pack sizes11 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 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) 0338-0017-41
Product NDC 0338-0017
11-digit billing NDC 00338001741
NCPDP billing unit ML — per mL (volume)
UNII LX22YL083G
Application # NDA016673
SPL Set ID 3bb406a9-f5cb-403a-b1bb-5c4facbea3d5
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1971-03-04
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance DEXTROSE MONOHYDRATE
GPI-14 80100020002015
GCN Seq No 001972
GCN 06641
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 0338-0017-41 — 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 → 00338-0017-41. 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 Corporation
Application holderBAXTER HEALTHCARE CORP
FDA applicationNDA016673 (NDA)
Labeler code00338
First marketedMar 1971
Product typeHuman Prescription Drug
Portfolio280 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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.1569 $7.85 / 50 ml
Medicare drug plans payPart D · Q2 2026 $0.0214 $1.07 / 50 ml
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)0338-0017-41
11-digit billing NDC00338-0017-41
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 50 g/1000mLthis 00338-0017-41 Baxter 50 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

🏛️
1971
On the market since
Mar 1971
📍
2026
Currently FDA-listed
55 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 00338-0017-41, 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
2.8K
Units reimbursed last 4 qtrs
610.9K
Gross reimbursed last 4 qtrs
$95.9K
Avg / prescription
$34.34
Avg / unit
$0.1569
Latest quarter Q4 2025
470Rx
Fee-for-service vs managed care
20% FFS 80% MCO
Fee-for-service · 564 Rx Managed care · 2,227 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 39,000 units · 499 per 100k residents WA Idaho: 70,500 units · 3,590 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 6,500 units · 113 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 97,500 units · 498 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 17,500 units · 548 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 97 units · 1.4 per 100k residents IN Ohio: 65,500 units · 556 per 100k residents OH Pennsylvania: 6,500 units · 50.2 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 82 units · 1.2 per 100k residents MA California: 7,818 units · 20.1 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 7,100 units · 115 per 100k residents MO Kentucky: 29,047 units · 642 per 100k residents KY West Virginia: 21,000 units · 1,186 per 100k residents WV Virginia: 26,038 units · 299 per 100k residents VA Maryland: 36,763 units · 595 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: 30,850 units · 433 per 100k residents TN North Carolina: 72,500 units · 669 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: 5,062 units · 172 per 100k residents MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 42,000 units · 138 per 100k residents TX Florida: 29,500 units · 130 per 100k residents FL
Units reimbursed · per 100k residents
1.23,590
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 Idaho 3,590 /100k
2 West Virginia 1,186 /100k
3 North Carolina 669 /100k
4 Kentucky 642 /100k
5 Maryland 595 /100k
6 Ohio 556 /100k
7 Nevada 548 /100k
8 Washington 499 /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.
25 ml00338-0017-02 13,836 Rx · $2,314,602
5 ml00338-0017-03 6,330 Rx · $518,063
1 ml00338-0017-04 5,708 Rx · $757,941
1 pouch00338-0017-10 3,433 Rx · $172,624
1 ml00338-0017-48 2,998 Rx · $931,227
5 ml this page00338-0017-41 2,791 Rx · $95,852
1 pouch00338-0017-18 2,293 Rx · $1,572,540
1 pouch00338-0017-11 1,855 Rx · $257,987
1 pouch00338-0017-31 1,155 Rx · $45,788
1 pouch00338-0017-38 696 Rx · $19,636
15 ml00338-0017-01 No Medicaid data
Drug total (last 4 qtrs): 41,095 Rx · 22,536,314 units · $6,686,261 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
00338-0017-01 150 mL in 1 BAG (0338-0017-01) 1971-03-04 Active
00338-0017-02 250 mL in 1 BAG (0338-0017-02) 1971-03-04 Active
00338-0017-03 500 mL in 1 BAG (0338-0017-03) 1971-03-04 Active
00338-0017-04 1000 mL in 1 BAG (0338-0017-04) 1971-03-04 Active
00338-0017-10 4 BAG in 1 POUCH (0338-0017-10) / 25 mL in 1 BAG 1971-03-04 Active
00338-0017-11 4 BAG in 1 POUCH (0338-0017-11) / 50 mL in 1 BAG 1971-03-04 Active
00338-0017-18 4 BAG in 1 POUCH (0338-0017-18) / 100 mL in 1 BAG 1971-03-04 Active
00338-0017-31 16 BAG in 1 POUCH (0338-0017-31) / 50 mL in 1 BAG 1971-03-04 Active
00338-0017-38 16 BAG in 1 POUCH (0338-0017-38) / 100 mL in 1 BAG 1971-03-04 Active
00338-0017-41 You're viewing this 1 BAG in 1 PACKAGE (0338-0017-41) / 50 mL in 1 BAG 1971-03-04 Active
00338-0017-48 1 BAG in 1 PACKAGE (0338-0017-48) / 100 mL in 1 BAG 1971-03-04 Active

This pack accounts for about 6.8% of this product's recent Medicaid fills; the largest share goes to the 25 ml pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 00338-0017-41?
NDC 00338-0017-41 contains 50 mL — 1 bag in 1 package / 50 ml in 1 bag.
What is the difference between NDC 00338-0017-41 and NDC 00338-0017-48?
Both are DEXTROSE 50 g/1000mL Injection, Solution — the drug itself is identical. NDC 00338-0017-41 is the 50 mL package, while NDC 00338-0017-48 is the 100 ml package.
What NDC number is used to bill for this package of DEXTROSE 50 g/1000mL Injection, Solution?
Bill NDC 00338-0017-41 — the 11-digit billing format is 00338001741. 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 0338-0017-41, 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: 00338-0017-41, written without dashes as 00338001741. 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 00338-0017-41, the first segment (00338) is the labeler code FDA assigned to Baxter Healthcare Corporation; the middle segment (0017) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (41) 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 Corporation. 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 10 other package presentations of this same product, including 1 pouch (00338-0017-10), 1 pouch (00338-0017-11), 1 pouch (00338-0017-18). 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 Corporation 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 78 words

1 INDICATIONS AND USAGE Dextrose Injection (5% and 10%) is indicated as 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 adults 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 information on preparation, administration, 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 (5.4 )]. • Avoid administering Dextrose Injection (5% and 10%) simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis.

If there is only a single IV access, flush the line thoroughly with normal saline before and after blood product administration. • Use of a final filter is recommended during administration of parenteral solutions, where possible. • It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. • Use promptly; do not store solutions containing additives. • Discard the unused portion. • To determine if chemotherapy agents are compatible with Dextrose solutions, consult the specific chemotherapy agent prescribing information to determine if Dextrose is 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). • The use of pressure infusion is not recommended as a method to increase flow rates.

However, if pressure infusion is required, ensure that any air within the bag is fully evacuated prior to initiation of infusion. • If using a pumping device to administer Dextrose Injection (5% and 10%), turn off the pump before the container is empty. To Open • Do not remove from overpouch until ready to use. • Tear overwrap down side at 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: o If the outlet port protector is damaged, detached, or not present, discard container. o 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. o Check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard container. Preparation for Administration 1.

Suspend container from eyelet support. 2. Remove protector from outlet port at bottom of container.

3. Attach administration set. Refer to complete directions accompanying set.

To Add Medication • Additives may be incompatible. Complete information is not available. Do not use additives known or determined to be incompatible. • Consult with pharmacist, if available.

If, in the informed judgment of the healthcare provider, it is deemed advisable to introduce additives, use aseptic technique. • Wh…

💊 Dosage Forms and Strengths 116 words

3 DOSAGE FORMS AND STRENGTHS Injection: • 5% (5 g/100 mL) (50 mg/mL) of dextrose hydrous a clear, sterile, non-pyrogenic solution in single-dose partial-fill flexible containers: 25 mL, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL • 10% (10 g/100 mL) (100 mg/mL) of dextrose hydrous in sing-dose partial-fill flexible containers: 250 mL, 500 mL, and 1000 mL Injection: • 5% (5 g/100 mL) (50 mg/mL) of dextrose hydrous in single-dose partial-fill flexible containers: 25 mL, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL. ( 3 ) • 10% (10 g/100 mL)(100 mg/mL) of dextrose hydrous in partial-fill flexible containers: 250 mL, 500 mL, and 1000 mL.

( 3 )

Contraindications 50 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 or 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 reactions occur.

( 5.3 ) • Phlebitis and Thrombosis : Remove catheter as soon as possible if thrombophlebitis develops. ( 2.2 , 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 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, 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 infusion rate, Dextrose Injection (5% and 10%) can cause fluid overload, including pulmonary edema.…

🤒 Adverse Reactions 210 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 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. 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 Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 175 words

7 DRUG INTERACTIONS 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 )

7.1Effects 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 patient’s 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 infants, 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 insufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Geriatric patients are at increased risk of developing hyponatremia as well as for developing 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 low and be titrated up cautiously, reflecting their greater risk for electrolyte abnormalities and fluid overload. Dextrose Injection (5% and 10%) 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 123 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 164 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 infants, excessive or rapid administration of Dextrose Injection (5% and 10%) may result in increased serum osmolality and risk of intracerebral hemorrhage.

🧓 Geriatric Use 163 words

8.5Geriatric Use Dextrose Injection (5% and 10%) has not been studied insufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Geriatric patients are at increased risk of developing hyponatremia as well as for developing 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 low and be titrated up cautiously, reflecting their greater risk for electrolyte abnormalities and fluid overload. Dextrose Injection (5% and 10%) 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 99 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 162 words

16 HOW SUPPLIED/STORAGE AND HANDLING Dextrose Injection (5% and 10%), USP is clear, colorless, sterile solutions of dextrose supplied in a single-dose, partial-fill flexible containers. Product Description Size Code NDC Dextrose Injection 5%, USP (5 g/100 mL) (50 mg/mL) 25 mL Quad pack 2B0080 0338-0017-10 50 mL Single pack Quad pack Multi pack 2B0086 2B0081 2B0088 0338-0017-41 0338-0017-11 0338-0017-31 100 mL Single pack Quad pack Multi pack 2B0087 2B0082 2B0089 0338-0017-48 0338-0017-18 0338-0017-38 250 mL 500 mL 1000 mL 2B0062 2B0063 2B0064 0338-0017-02 0338-0017-03 0338-0017-04 Dextrose Injection 10%, USP (10 g/100 mL) (100 mg/mL) 250 mL 500 mL 1000 mL 2B0162 2B0163 2B0164 0338-0023-02 0338-0023-03 0338-0023-04 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); brief exposure up to 40°C/104°F does not adversely affect the product.

📋 Description ~2 min read

11 DESCRIPTION Dextrose Injection, 5% and 10% USP are sterile, non-pyrogenic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration as a source of water and calories. Partial-fill containers, designed to facilitate admixture when necessary, are available in 25 mL, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 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% and 10%, 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 Osmolarity (mOsmol per liter) Dextrose Injection 5%, USP (0.05 grams/mL) 25 mL Quad pack 1.25 grams 4.25 252 50 mL Single pack Quad pack Multi pack 2.5 grams 8.5 252 100 mL Single pack Quad pack Multi pack 5 grams 17 252 250 mL 12.5 grams 42.5 252 500 mL 25 grams 85 252 1000 mL 50 grams 170 252 Dextrose Injection 10%, USP (0.1 grams/mL) 250 mL 25 grams 85 505 500 mL 50 grams 170 505 1000 mL 100 grams 340 505 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 H2O. Dextrose is derived from corn.

The VIAFLEX Plus plastic container is fabricated from 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. Solutions in contact with the plastic container can leach out certain of its chemical components in small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. 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.

Dextrose Hydrous Structural Formula

💬 Information for Patients 29 words

17 PATIENT COUNSELING INFORMATION Manufactured by, Packed by, Distributed by: Baxter Healthcare Corporation Deerfield, IL 60015 USA Printed in USA Baxter and Viaflex are trademarks of Baxter International Inc.

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.