HomeNDC LookupIngredientsDextrose Monohydrate › 00338-0719-06
DEXTROSE 70 g/100mL Injection, Solution, 2000 mL — NDC 00338-0719-06 package photo

DEXTROSE 70 g/100mL Injection, Solution, 2000 mL

by Baxter Healthcare Corporation · 2000 mL in 1 BAG (0338-0719-06)
NDC 00338-0719-06
🏷️ FDA NDC (as labeled) 0338-0719-06 billing pads the labeler segment with a zero
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 70% Injection is currently reported in shortage by the FDA (Other). Unavailable 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) 0338-0719-06
Product NDC 0338-0719
11-digit billing NDC 00338071906
NCPDP billing unit ML — per mL (volume)
RxCUI 237656
UNII LX22YL083G
Application # NDA020047
SPL Set ID 0332f34a-7038-47cc-ba59-d55cad6b73ca
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1991-07-02
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance DEXTROSE MONOHYDRATE
GPI-14 80100020002060
GPI class Dextrose
GCN Seq No 001993
GCN 06810
HICL code 000929
Ingredient (HICL) Dextrose 70 % 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 70%-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 0338-0719-06 — 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 → 00338-0719-06. 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 applicationNDA020047 (NDA)
Labeler code00338
First marketedJul 1991
Product typeHuman Prescription Drug
Portfolio281 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 70%-WATER IV SOLN Ingredient Dextrose 70 % 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 $0.1790 $358.00 / 2000 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J7799 No ASP payment limit on file for J7799 this quarter.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🧾 Billing & reimbursement

FDA NDC (as labeled)0338-0719-06
11-digit billing NDC00338-0719-06
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 70 g/100mL 00264-7387-50 B. 2000 ml AP FDA listed
Dextrose 70 g/100mLthis 00338-0719-06 Baxter 2000 ml AP FDA listed
Dextrose 70 g/100mL 00990-7120-07 ICU 6 pouches AP FDA listed
Dextrose 70 g/100mL 00990-7918-19 ICU 12 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

🏛️
1991
On the market since
Jul 1991
📍
2026
Currently FDA-listed
35 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 00338-0719-06, 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
41.6K
Units reimbursed last 4 qtrs
63.4M
Gross reimbursed last 4 qtrs
$11.35M
Avg / prescription
$272.71
Avg / unit
$0.1790
Latest quarter Q4 2025
11.3KRx
Fee-for-service vs managed care
90% FFS
Fee-for-service · 37,369 Rx Managed care · 4,247 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: 269,323 units · 23,792 per 100k residents MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 2,365,147 units · 40,019 per 100k residents WI Michigan: no data reported MI New York: 6,708,110 units · 34,276 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 143,225 units · 3,384 per 100k residents OR Nevada: 6,643 units · 208 per 100k residents NV Wyoming: 99,006 units · 16,953 per 100k residents WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 6,531,971 units · 52,052 per 100k residents IL Indiana: no data reported IN Ohio: 3,424,934 units · 29,062 per 100k residents OH Pennsylvania: 184,426 units · 1,423 per 100k residents PA New Jersey: 36,171 units · 389 per 100k residents NJ Massachusetts: no data reported MA California: 23,817,767 units · 61,126 per 100k residents CA Utah: 53,056 units · 1,553 per 100k residents UT Colorado: 3,051,046 units · 51,906 per 100k residents CO Nebraska: 59,094 units · 2,988 per 100k residents NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 8,084 units · 92.7 per 100k residents VA Maryland: 1,669,489 units · 27,014 per 100k residents MD Connecticut: 3,721,793 units · 102,897 per 100k residents 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: 890,529 units · 8,219 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 1,900 units · 46.9 per 100k residents OK Louisiana: no data reported LA Mississippi: 363,888 units · 12,377 per 100k residents MS Alabama: 5,584,700 units · 109,332 per 100k residents AL Georgia: 4,160,711 units · 37,725 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 266,823 units · 1,180 per 100k residents FL
Units reimbursed · per 100k residents
46.9109,332
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 Alabama 109,332 /100k
2 Connecticut 102,897 /100k
3 California 61,126 /100k
4 Illinois 52,052 /100k
5 Colorado 51,906 /100k
6 Wisconsin 40,019 /100k
7 Georgia 37,725 /100k
8 New York 34,276 /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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00338-0719-06 You're viewing this 2000 mL in 1 BAG (0338-0719-06) 1991-07-02 Active

🧭 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 0338-0719-06, 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: 00338-0719-06, written without dashes as 00338071906. 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 00338-0719-06, the first segment (00338) is the labeler code FDA assigned to Baxter Healthcare Corporation; the middle segment (0719) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (06) 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.
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 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 80 words

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

( 1 )

⏱️ Dosage and Administration ~3 min read

2 DOSAGE AND ADMINISTRATION • Pharmacy Bulk Package. Not for direct intravenous infusion. ( 2.1 ) • For slow intravenous infusion only into a: ( 2.2 ) o Central vein, if final dextrose concentration is greater than 5% or osmolality is greater than 900 mOsm/L approximately. o Peripheral vein, if final dextrose concentration 5% or less and osmolality is less than 900 mOsm/L approximately. • Individualize dosage based on the patient’s clinical condition, body weight, nutritional/fluid requirements, as well as additional energy given orally/enterally.

( 2.3 ) • Discontinue infusion of concentrated dextrose solutions slowly. ( 2.4 )

2.1Preparation Instructions Prior to Administration Dextrose Injection is supplied as a pharmacy bulk package for admixing only and is not for direct intravenous infusion. Dextrose Injection is intended for use in the preparation of sterile, intravenous admixtures. Prior to administration, Dextrose Injection must be transferred to a separate PN container , diluted with other compatible intravenous fluids and used as an admixture in PN solutions. • Do not remove from overpouch until ready to use. • Tear protective overwrap 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. • Inspect Dextrose Injection prior to use.

Opacity of the container may be observed due to moisture absorption during the sterilization process. 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 as solution path sterility may be impaired. o Check for minute leaks by squeezing the inner container firmly. If leaks are found, discard solution as sterility may be impaired. o Do not use unless solution is clear and container is intact. • Because additives may be incompatible, evaluate all additions for compatibility and stability of the resulting preparation. Consult with a pharmacist, if available.

If it is deemed advisable to introduce additives, use aseptic technique and mix thoroughly. • Calcium and phosphate ratios must be considered. Excess addition of calcium and phosphate, especially in the form of mineral salts, may result in the formation of calcium phosphate precipitates [see Warnings and Precautions (5.1)] . Preparation for Admixing 1.

The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). 2. Suspend container from eyelet support.

3. Remove plastic protector from outlet port at bottom of container. 4.

Attach solution transfer set. Refer to complete directions accompanying set. Note: The closure shall be penetrated only one time with a suitable sterile transfer device or dispensing set which allows measured dispensing of the contents.

5. The VIAFLEX plastic container should not be written on directly since ink migration has not been investigated. Affix accompanying label for date and time of entry notation.

6. Once container closure has been penetrated, withdrawal of contents should be completed without delay. After initial entry, maintain contents at room temperature (25°C/77°F) and dispense within 4 hours.

2.2Important Administration Instructions • Dextrose Injection is for admixing use only and is not for direct intravenous infusion . Prior to administration, Dextrose Injection must be diluted with other compatible intravenous fluids and used as an admixture in PN solutions . • 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 administratio…

💊 Dosage Forms and Strengths 60 words

3 DOSAGE FORMS AND STRENGTHS Dextrose Injection 70%, USP is a sterile, non-pyrogenic, hypertonic solution of 70 grams of dextrose hydrous per 100 mL (0.7 grams/mL) in a 2000 mL Pharmacy Bulk Package flexible container. • Injection: 70% (0.7 grams/mL), 70 grams of dextrose hydrous per 100 mL in a 2000 mL Pharmacy Bulk Package flexible container. ( 3 )

Contraindications 48 words

4 CONTRAINDICATIONS The use of Dextrose Injection is contraindicated in patients: • Who are severely dehydrated as hypertonic dextrose solution can worsen the patient’s hyperosmolar state [see Warnings and Precautions (5.2)] . • Known hypersensitivity to dextrose [see Warnings and Precautions (5.3)] . Severe dehydration. ( 4 )

⚠️ Warnings and Cautions ~3 min read

5 WARNINGS AND PRECAUTIONS • Pulmonary Embolism due to Pulmonary Vascular Precipitates : If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. ( 5.1 ) • Hyperglycemia or Hyperosmolar Hyperglycemic State : Monitor blood glucose and administer insulin as needed. ( 5.2 ) • Hypersensitivity Reactions : Monitor for signs and symptoms and discontinue infusion if reactions occur.

( 5.3 ) • Vein Damage and Thrombosis : Administer solutions containing more than 5% dextrose as the final concentration or solutions with an osmolarity of approximately 900 mOsm/L or greater through a central vein. ( 2.2 , 5.4 ) • Hyponatremia: Monitor serum sodium to minimize the risk of hypo- or hyperosmotic hyponatremia. ( 5.5 ) • Risk of Infection : Monitor for signs and symptoms and laboratory parameters.

( 5.6 ) • Refeeding Syndrome : Monitory laboratory parameters. ( 5.7 ) • Hepatobiliary Disorders : Monitor liver function parameters and ammonia levels. ( 5.8 ) • Aluminum Toxicity : Dextrose Injection contains aluminum that may be toxic.

Adult patients with impaired renal function and preterm infants are at higher risk. Limit aluminum to less than 4 mcg/kg/day ( 5.9 , 8.4 ) • Parenteral Nutrition Associated Liver Disease : Increased risk in patients who receive parenteral nutrition for extended periods of time, especially preterm infants; monitor liver function tests, if abnormalities occur consider discontinuation or dosage reduction. ( 5.10 , 8.4 ) • Electrolyte Imbalance and Fluid Overload : Monitor daily fluid balance, blood electrolyte levels, correct as needed.

( 5.11 , 8.4 )

5.1Pulmonary Embolism due to Pulmonary Vascular Precipitates Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition. In some cases, fatal outcomes due to pulmonary embolism have occurred. Patients, especially those with hypophosphatemia, may require the addition of phosphate.

To prevent hypocalcemia, calcium supplementation should always accompany phosphate administration. Excessive addition of calcium and phosphate increases the risk of the formation of calcium phosphate precipitates. Precipitates have been reported even in the absence of phosphate salt in the solution.

Precipitation following passage through an in-line filter and suspected in vivo precipitate formation has also been reported. If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. In addition to inspection of the solution [see Dosage and Administration (2.1 , 2.2 )] , the infusion set and catheter should also periodically be checked for precipitates.

5.2Hyperglycemia 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 (5.11) ] .

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.

5.3Hypersensitivity 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. Signs or symptoms may include: pruritis, bronchospasm, cyanosis, angioedema, hypotension, pyrexia, chills, and rash.

5.4 Vein Damage and Thrombosis Dextrose Inject…

🤒 Adverse Reactions ~1 min read

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: • Pulmonary embolism due to pulmonary vascular precipitates [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) ] • Vein damage and thrombosis [see Warnings and Precautions (5.4) ] • H yponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.5) ] • Risk of infections [see Warnings and Precautions (5.6) ] • Refeeding syndrome [see Warnings and Precautions (5.7) ] • Aluminum toxicity [see Warnings and Precautions (5.9) ] • Hepatobiliary disorders [see Warnings and Precautions (5.8) ] • Risk of parenteral nutrition associated liver disease [see Warnings and Precautions (5.10) ] • Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.11) ] The most common adverse reactions are, hyperglycemia, hypersensitivity reactions, infection both systemic and at the injection site, and vein thrombosis or phlebitis.

( 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 101 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 and fluid and/or electrolyte balance [see Warnings and Precautions (5.2 , 5.5 , 5.11 )] . 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, or fluid and/or electrolyte balance (such as diuretics and anti-epileptics).

👥 Use in Specific Populations ~3 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. However, maternal hyperglycemia secondary to infusion of glucose-containing products at the time of delivery has been associated with adverse neonatal outcomes such as neonatal hypoglycemia. Malnutrition in pregnant women is associated with adverse maternal and fetal outcomes (see Clinical Considerations).

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. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Severe malnutrition in pregnant women is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality. Parenteral nutrition should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake.

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. Plasma electrolyte concentrations should be closely monitored 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. Because of immature renal function, preterm infants receiving prolonged treatment with dextrose injection, may be at risk of aluminum toxicity [see Warnings and Precautions (5.9) ]. Patients, including pediatric patients, may be at risk for Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions (5.10) ] .

Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy.

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 (5.5)] . 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. This…

🤰 Pregnancy 178 words

8.1Pregnancy Risk Summary Appropriate administration of Dextrose Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. However, maternal hyperglycemia secondary to infusion of glucose-containing products at the time of delivery has been associated with adverse neonatal outcomes such as neonatal hypoglycemia. Malnutrition in pregnant women is associated with adverse maternal and fetal outcomes (see Clinical Considerations).

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. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Severe malnutrition in pregnant women is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality. Parenteral nutrition should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake.

🧒 Pediatric Use 169 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. Plasma electrolyte concentrations should be closely monitored 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. Because of immature renal function, preterm infants receiving prolonged treatment with dextrose injection, may be at risk of aluminum toxicity [see Warnings and Precautions (5.9) ]. Patients, including pediatric patients, may be at risk for Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions (5.10) ] .

Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy.

🧓 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 (5.5)] . 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. This drug 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 a concentrated dextrose solution can cause hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance [see Warnings and Precautions (5.2 , 5.11) ] . Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal. Discontinue infusion 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 28 words

12 CLINICAL PHARMACOLOGY

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

🧬 Mechanism of Action 25 words

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

📦 How Supplied / Storage and Handling 95 words

16 HOW SUPPLIED/STORAGE AND HANDLING Dextrose Injection 70%, USP (0.7 grams/mL) is available in a Pharmacy Bulk Package flexible plastic container for intravenous administration after appropriate dilution [see Dosage and Administration (2.1) ] and is available in the following size in Table 2 below. Table 2 Product Description Code Volume NDC Dextrose Injection 70%, USP (0.7 grams/mL) 2B0296 2000 mL 0338-0719-06 Do not remove container from the overwrap until ready to use. Store at room temperature (25°C /77°F).

Do not freeze. Avoid excessive heat. For storage of admixed solution, see Dosage and Administration (2.1) .

📋 Description ~1 min read

11 DESCRIPTION Dextrose Injection 70%, USP is a clear, sterile, nonpyrogenic, hypertonic solution of Dextrose, USP in Water for Injection in a flexible plastic container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program.

Dextrose Injection is not for direct intravenous infusion [see Dosage and Administration (2.1) ] . The Pharmacy Bulk Package is designed to facilitate admixture or dilution to provide dextrose in various concentrations and is available in a 2000 mL size. 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 following admixture or dilution. 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 70%, USP Strength Fill Volume Amount of Dextrose Hydrous, USP per container kcal Caloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous per Container Osmolarity (mOsmol per liter) (calc.) Dextrose Injection 70%, USP (0.7 grams/mL) 2000 mL 1400 grams 4760 3530 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 70%, USP contains no more than 25 mcg/L of aluminum. Dextrose is derived from corn.

Structural formula of Dextrose Hydrous, USP

💬 Information for Patients 135 words

17 PATIENT COUNSELING INFORMATION Inform patients, caregivers, or home healthcare providers of the following risks of Dextrose Injection: • Pulmonary embolism due to pulmonary vascular precipitates [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) ] • Vein damage and thrombosis [see Warnings and Precautions (5.4) ] • Hyponatremia [see Warnings and Precautions (5.5) ] • Risk of infections [see Warnings and Precautions (5.6) ] • Refeeding syndrome [see Warnings and Precautions (5.7) ] • Hepatobiliary disorders [see Warnings and Precautions (5.8) ] • Aluminum toxicity [see Warnings and Precautions (5.9) ] • Risk of parenteral nutrition associated liver disease [see Warnings and Precautions (5.10) ] • Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.11) ]

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.