Dextrose and Sodium Chloride 5 g/100mL; 450 mg/100mL Injection, Solution — NDC 00338-0085-04 package photo

Dextrose and Sodium Chloride 5 g/100mL; 450 mg/100mL Injection, Solution

by Baxter Healthcare Company · 14 BAG in 1 CARTON (0338-0085-04) / 1000 mL in 1 BAG
NDC 00338-0085-04
🏷️ FDA NDC (as labeled) 0338-0085-04 billing pads the labeler segment with a zero
This package
Contains1000 mL in 1 bag Medicaid pays$0.0220 / unit · 12 mo Per package$308.00 / 14000 ml · Medicaid Pack sizes2 compare ↓
Also priced by: Part D plans $0.0058/unit — full pricing hub ↓
Also comes in: 500 ml 00338-0085-03
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 10, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 0338-0085-04
Product NDC 0338-0085
11-digit billing NDC 00338008504
NCPDP billing unit ML — per mL (volume)
UNII LX22YL083G, 451W47IQ8X
Application # NDA016683
SPL Set ID dcbf1907-1841-4afc-ab5d-a9893a2d7256
Established class (EPC) Osmotic Laxative
Mechanism of action Osmotic Activity
Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1971-03-22
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance DEXTROSE MONOHYDRATE; SODIUM CHLORIDE
GPI-14 79993002202030
GPI class Dextrose-NaCl
GCN Seq No 002006
GCN 06940
HICL code 000936
Ingredient (HICL) Dextrose 5 %-0.45 % Sod Chlord
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C5
Therapeutic class — intermediate (HIC2) Carbohydrates And/Or Proteins
HIC3 code C5K
Therapeutic class — specific (HIC3) Iv Solutions: Dextrose-Saline
AHFS code 40:20.00.00
AHFS class Caloric Agents
FDB label name DEXTROSE 5%-0.45% NACL IV SOLN
FDB brand name Dextrose 5%-0.45% Nacl
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 0338-0085-04 — 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 → 00338-0085-04. 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 applicationNDA016683 (NDA)
Labeler code00338
First marketedMar 1971
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%-0.45% NACL IV SOLN Ingredient Dextrose 5 %-0.45 % Sod Chlord
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 $0.0220 $308.00 / 14000 ml
Medicare drug plans payPart D · Q2 2026 $0.0058 $81.20 / 14000 ml
Medicare Part B allowsASP · J7799 No ASP payment limit on file for J7799 this quarter.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🧾 Billing & reimbursement

FDA NDC (as labeled)0338-0085-04
11-digit billing NDC00338-0085-04
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 and Sodium Chloride 5 g/100mL; 450 mg/100mLthis 00338-0085-04 Baxter 1000 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 00338-0085-04, 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
6.6K
Units reimbursed last 4 qtrs
10M
Gross reimbursed last 4 qtrs
$220.7K
Avg / prescription
$33.22
Avg / unit
$0.0220
Latest quarter Q4 2025
1.3KRx
Fee-for-service vs managed care
32% FFS 68% MCO
Fee-for-service · 2,106 Rx Managed care · 4,536 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: 14,014 units · 1,238 per 100k residents MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 2,006,370 units · 10,252 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 25,000 units · 783 per 100k residents NV Wyoming: no data reported WY South Dakota: 2,033 units · 221 per 100k residents SD Iowa: no data reported IA Illinois: 298,000 units · 2,375 per 100k residents IL Indiana: 115,000 units · 1,676 per 100k residents IN Ohio: 195,503 units · 1,659 per 100k residents OH Pennsylvania: 482,507 units · 3,723 per 100k residents PA New Jersey: 279,000 units · 3,003 per 100k residents NJ Massachusetts: 3,569 units · 51.0 per 100k residents MA California: 941,952 units · 2,417 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 613,000 units · 9,893 per 100k residents MO Kentucky: 965,846 units · 21,340 per 100k residents KY West Virginia: 514,000 units · 29,040 per 100k residents WV Virginia: 105,001 units · 1,205 per 100k residents VA Maryland: 311,617 units · 5,042 per 100k residents MD Connecticut: 206,001 units · 5,695 per 100k residents CT Rhode Island: no data reported RI Arizona: 414,000 units · 5,571 per 100k residents AZ New Mexico: 88,506 units · 4,187 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 864,000 units · 12,125 per 100k residents TN North Carolina: 595,900 units · 5,500 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 73,200 units · 1,600 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: 14,500 units · 2,135 per 100k residents DC Hawaii: no data reported HI Texas: 472,003 units · 1,547 per 100k residents TX Florida: 447,700 units · 1,980 per 100k residents FL
Units reimbursed · per 100k residents
51.029,040
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 West Virginia 29,040 /100k
2 Kentucky 21,340 /100k
3 Tennessee 12,125 /100k
4 New York 10,252 /100k
5 Missouri 9,893 /100k
6 Connecticut 5,695 /100k
7 Arizona 5,571 /100k
8 North Carolina 5,500 /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.
1 ml this page00338-0085-04 6,642 Rx · $220,677
5 ml00338-0085-03 1,338 Rx · $14,275
Drug total (last 4 qtrs): 7,980 Rx · 10,748,370 units · $234,952 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for DEXTROSE and SODIUM CHLORIDE — the ingredient across all brands.

Top reported reactions

Vomiting39
Nausea33
Hyponatraemia27
Ascites26
Constipation26
Sepsis26
Abdominal Distension25

Reporter sex

0 reports

Serious outcomes

Hospitalization107
Death56
Life-threatening33
Disabling25
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 25 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00338-0085-03 24 BAG in 1 CARTON (0338-0085-03) / 500 mL in 1 BAG 1971-03-22 Active
00338-0085-04 You're viewing this 14 BAG in 1 CARTON (0338-0085-04) / 1000 mL in 1 BAG 1971-03-22 Active

In Medicaid, this is the most-dispensed pack of this product — about 83% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00338-0085-04?
NDC 00338-0085-04 is listed by the FDA — 14 bag in 1 carton / 1000 ml in 1 bag.
What NDC number is used to bill for this package of Dextrose and Sodium Chloride 5 g/100mL; 450 mg/100mL Injection, Solution?
Bill NDC 00338-0085-04 — the 11-digit billing format is 00338008504. 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 0338-0085-04, 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: 00338-0085-04, written without dashes as 00338008504. 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 00338-0085-04, the first segment (00338) is the labeler code FDA assigned to Baxter Healthcare Company; the middle segment (0085) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 500 ml (00338-0085-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
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 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 37 words

1 INDICATIONS AND USAGE Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes and calories. Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes and calories. ( 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 and Sodium Chloride Injection is only for intravenous infusion. • The osmolarity of Dextrose and Sodium Chloride Injection, ranges from 280 to 560 mOsmol/L (calc). Peripheral administration is generally acceptable; however; consider central vein administration if there is peripheral vein irritation, phlebitis, and/or associated pain. • Do not administer Dextrose and Sodium Chloride 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 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 the specific, sodium chloride, and dextrose concentrations, 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 (5.2) , Use in Specific Populations (8.4) ] .

2.3Instructions for Use To Open • Do not remove container from overwrap until ready to use. • Tear overwrap down side at slit and remove solution container. • 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 squeezing 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. • When introducing additives, consult the instructions for use of the medication to be added and other relevant literature. • Before adding a substance or medication, verify that it is soluble and/or stable in Dextrose and Sodium Chloride Injection and that the pH range of Dextrose and Sodium Chloride Injection is appropriate.

To Add Medication Before Solution Administration 1. Prepare medication site. 2.

Using syringe with 19 to 22-gauge needle, puncture resealable medication port and inject…

💊 Dosage Forms and Strengths 122 words

3 DOSAGE FORMS AND STRENGTHS Dextrose and Sodium Chloride Injection are clear solutions in 250 mL, 500 mL and 1000 mL single-dose, flexible containers: 250 mL flexible container • 5% Dextrose and 0.2% Sodium Chloride Injection, USP 500 mL flexible container • 5% Dextrose and 0.45% Sodium Chloride Injection, USP • 5% Dextrose and 0.9% Sodium Chloride Injection, USP 1000 mL flexible container • 2.5% Dextrose and 0.45% Sodium Chloride Injection, USP • 5% Dextrose and 0.2% Sodium Chloride Injection, USP • 5% Dextrose and 0.45% Sodium Chloride Injection, USP • 5% Dextrose and 0.9% Sodium Chloride Injection, USP Dextrose and Sodium Chloride Injection is available in multiple strengths.

See full prescribing information for detailed description of each product. ( 3 )

Contraindications 58 words

4 CONTRAINDICATIONS Dextrose and Sodium Chloride Injection is contraindicated in patients with: • known hypersensitivity to dextrose and/or sodium chloride [see Warnings and Precautions 5.1) ] • clinically significant hyperglycemia [see Warnings and Precautions (5.2) ] • Known hypersensitivity to dextrose, or sodium chloride ( 4 , 5.1 ) • Clinically significant hyperglycemia ( 4 , 5.2 )

⚠️ Warnings and Cautions ~3 min read

5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions : Monitor for signs and symptoms and discontinue infusion if reactions occur. ( 5.1 ) • Hyperglycemia or Hyperosmolar Hyperglycemic State : Monitor blood glucose and administer insulin as needed. ( 5.2 , 8.4 ) • Hyponatremia, Hypokalemia, Hypernatremia and Hyperchloremia : Avoid in patients with or at risk for hypo-/hypernatremia and hypokalemia.

If use cannot be avoided, monitor serum sodium and potassium concentrations. ( 5.3 , 5.4 , 5.5 , 8.4 ) • Fluid Overload : Avoid in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor daily fluid balance and electrolyte, concentrations and acid-base balance, as needed and especially during prolonged use.

( 5.6 ) • Refeeding Syndrome : Monitor severely undernourished patients and slowly increase nutrient intake. ( 5.7 )

5.1Hypersensitivity Reactions Hypersensitivity and infusion reactions, including anaphylaxis, have been reported with Dextrose and Sodium Chloride Injection [see Adverse Reactions (6) ]. Stop the infusion immediately if signs or symptoms of a hypersensitivity or infusion reaction develops [see Contraindications (4) ]. Appropriate therapeutic countermeasures must be instituted as clinically indicated.

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.

Patients with underlying central nervous system disease and renal impairment who receive dextrose infusions, may be at greater risk of developing hyperosmolar hyperglycemic state. Monitor blood glucose concentrations and treat hyperglycemia to maintain concentrations within normal limits while administering Dextrose and Sodium Chloride Injection. Insulin may be administered or adjusted to maintain optimal blood glucose concentrations.

5.3Hyponatremia Dextrose and Sodium Chloride Injection is a hypertonic 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. 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 certain diuretic, antiepileptic and psychotropic medications) [see Drug Interactions (7.1) ].

Acute hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury. Patients at increased risk for developing complications of hyponatremia, such as hyponatremic encephalopathy include pediatric patients; women, in particular, premenopausal women; patients with hypoxemia; and in patients with underlying central nervous system disease [see Use in Specific Populations (8.4 , 8.5 )].

Avoid Dextrose and Sodium Chloride Injection in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations. Rapid correction of hyponatremia is potentially dangerous with risk of serious neurologic complications such as osmotic demyelination syndrome with risk of seizures and cerebral edema.

To avoid complications, monitor ser…

🤒 Adverse Reactions 114 words

6 ADVERSE REACTIONS - Anaphylactic reaction, hypersensitivity, and chills - Hyponatremia (applies to solutions containing less than 0.9% Sodium Chloride) Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

Adverse reactions include electrolyte imbalances, hyperglycemia, and hypervolemia and injection site reactions. ( 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 157 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 ) • Lithium : Decreased lithium concentrations with concomitant use; monitor serum lithium concentrations. ( 7.2 )

7.1Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance Dextrose and Sodium Chloride Injection can affect glycemic control, vasopressin and fluid and/or electrolyte balance [see Warnings and Precautions (5.2 , 5.3 , 5.4 , 5.5 , 5.6) ] . Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations and acid-base balance when using Dextrose and Sodium Chloride Injection in patients treated with other substances that affect glycemic control, vasopressin or fluid and/or electrolyte balance.

7.2Lithium Renal sodium and lithium clearance may be increased during administration of Dextrose and Sodium Chloride Injection resulting in decreased serum lithium concentrations. Monitor serum lithium concentrations during concomitant use.

👥 Use in Specific Populations ~2 min read

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Appropriate administration of Dextrose and Sodium Chloride Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with Dextrose and Sodium Chloride Injection. 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 Sodium is present in human breast milk. There are no data on the effects of Dextrose and Sodium Chloride Injection on a breastfed infant or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Dextrose and Sodium Chloride Injection and any potential adverse effects on the breastfed infant from Dextrose and Sodium Chloride Injection or from the underlying maternal condition.

8.4Pediatric Use The safety profile of Dextrose and Sodium Chloride 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 solutions 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 and Sodium Chloride 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.

8.5Geriatric Use Clinical studies of Dextrose and Sodium Chloride 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 (5.3) ] . Dextrose and Sodium Chloride Injection is known to be substantially excreted by the kidney, and the risk of adverse reactions to this product may be greater in patients with impaired renal function [see Warnings and Precautions (5.2 , 5.5) ] .

Dose selection for an elderly patient should be cautious, 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.

8.6Renal Impairment Administration of Dextrose and Sodium Chloride Injection in patients with renal impairment may result in hyperosmolar hyperglycemic state, hyponatremia, and/or fluid overload. Monitor patients with renal impairment for development of these adverse reactions [see Warnings and Precautions (5.2 , 5.3 , 5.5 , 5.6) ] .

🤰 Pregnancy 96 words

8.1Pregnancy Risk Summary Appropriate administration of Dextrose and Sodium Chloride Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with Dextrose and Sodium Chloride Injection. 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 125 words

8.4Pediatric Use The safety profile of Dextrose and Sodium Chloride 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 solutions 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 and Sodium Chloride 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.

🧓 Geriatric Use 132 words

8.5Geriatric Use Clinical studies of Dextrose and Sodium Chloride 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 (5.3) ] . Dextrose and Sodium Chloride Injection is known to be substantially excreted by the kidney, and the risk of adverse reactions to this product may be greater in patients with impaired renal function [see Warnings and Precautions (5.2 , 5.5) ] .

Dose selection for an elderly patient should be cautious, 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.

🆘 Overdosage 162 words

10 OVERDOSAGE Excessive administration of Dextrose and Sodium Chloride Injection can cause: Electrolyte and Fluid Disorders • Hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance, and corresponding complications, which can be fatal [see Warnings and Precautions (5.2) ] . • Hyponatremia, manifestations may include seizures, coma, cerebral edema and death) [see Warnings and Precautions (5.3) ] . • Hypernatremia, especially in patients with severe renal impairment [see Warnings and Precautions (5.5) ] . • Fluid overload (which can lead to central and/or peripheral edema) [see Warnings and Precautions (5.6) ] .

When assessing an overdose, any additives in the solution must also be considered. Clinically significant overdose of Dextrose and Sodium Chloride Injection may, therefore, constitute a medical emergency. The effects of an overdose may require immediate medical attention and treatment.

Interventions include discontinuation of the infusion, dose reduction, monitoring of fluid balance, electrolyte concentrations and acid-base balance and institution of appropriate corrective measures such as administration of exogenous insulin.

🧬 Clinical Pharmacology 64 words

12 CLINICAL PHARMACOLOGY Dextrose and Sodium Chloride Injection, USP has value as a source of water, electrolytes, and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.

12.1Mechanism of Action Dextrose and Sodium Chloride Injection is a source of water, electrolytes and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.

🧬 Mechanism of Action 31 words

12.1Mechanism of Action Dextrose and Sodium Chloride Injection is a source of water, electrolytes and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.

📦 How Supplied / Storage and Handling 107 words

16 HOW SUPPLIED/STORAGE AND HANDLING Dextrose and Sodium Chloride Injection are clear solutions in 250 mL, 500 mL and 1000 mL single-dose, flexible containers available as follows: Code Size (mL) NDC Product Name 2B1024 1000 0338-0073-04 2.5% Dextrose and 0.45% Sodium Chloride Injection, USP 2B1092 250 0338-0077-02 5% Dextrose and 0.2% Sodium Chloride Injection, USP 2B1094 1000 0338-0077-04 2B1073 500 0338-0085-03 5% Dextrose and 0.45% Sodium Chloride Injection, USP 2B1074 1000 0338-0085-04 2B1063 500 0338-0089-03 5% Dextrose and 0.9% Sodium Chloride Injection, USP 2B1064 1000 0338-0089-04 Storage : Avoid excessive heat.

Store at room temperature (25°C/77°F); brief exposure up to 40°C/104°F does not adversely affect the product.

📋 Description ~1 min read

11 DESCRIPTION Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in single-dose containers for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1 .

Table 1. Size (mL) Composition (g/L) Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Osmolarity (mOsmol/L) (calc.) pH Ionic Concentration (mEq/L) Caloric Content (kcal/L) **Dextrose Hydrous, USP Sodium Chloride, USP (NaCl) Sodium Chloride 2.5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 25 4.5 280 4.5 (3.2 to 6.5) 77 77 85 5% Dextrose and 0.2% Sodium Chloride Injection, USP 250 1000 50 2 321 4.0 (3.2 to 6.5) 34 34 170 5% Dextrose and 0.33% Sodium Chloride Injection, USP 250 1000 50 3.3 365 4.0 (3.2 to 6.5) 56 56 170 5% Dextrose and 0.45% Sodium Chloride Injection, USP 500 1000 50 4.5 406 4.0 (3.2 to 6.5) 77 77 170 5% Dextrose and 0.9% Sodium Chloride Injection, USP 500 1000 50 9 560 4.0 (3.2 to 6.5) 154 154 170 Dextrose is derived from corn.

The VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). 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. Dextrose Structural Formula

💬 Information for Patients 123 words

17 PATIENT COUNSELING INFORMATION Inform patients, caregivers or home healthcare providers of the following risks of Dextrose and Sodium Chloride Injection: • Hypersensitivity reactions [see Warnings and Precautions (5.1) ] • Hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions (5.2) ] • Hyponatremia [see Warnings and Precautions (5.3) ] • Hypokalemia [see Warnings and Precautions (5.4) ] • Hypernatremia and hyperchloremia [see Warnings and Precautions (5.5) ] • Fluid overload [see Warnings and Precautions (5.6) ] • Refeeding syndrome [see Warnings and Precautions (5.7) ] Baxter Healthcare Corporation Deerfield, IL 60015 USA Printed in USA Distributed in Canada by Baxter Corporation Mississauga, ON L5N 0C2 07-19-00-9764 Baxter, and Viaflex and PL 146 are trademarks of Baxter International Inc.

For Product Information 1-800-933-0303

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.