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Dextrose and Sodium Chloride 5 g/100mL; .3 g/100mL Injection, Solution — NDC 63323-0867-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dextrose and Sodium Chloride 5 g/100mL; .3 g/100mL Injection, Solution — NDC 63323-867-10 (Billing 63323-0867-10)

by Fresenius Kabi USA, LLC · 10 BAG in 1 CASE / 1000 mL in 1 BAG

This is a package of Dextrose and Sodium Chloride 5 g/100mL; .3 g/100mL Injection, Solution from Fresenius Kabi USA, LLC, marketed since Oct 2020 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 63323-0867-10
🏷️ FDA NDC (as labeled) 63323-867-10 billing pads the product segment with a zero
This package
Contains1000 mL in 1 bag Pack sizes3 compare ↓
Main listing for product 63323-867 · Also comes in: 250 ml 63323-867-75 500 ml 63323-867-74
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63323-867-10
Product NDC 63323-867
11-digit billing NDC 63323086710
NCPDP billing unit ML — per mL (volume)
RxCUI 1795147, 1795149, 1795150
UNII LX22YL083G, 451W47IQ8X
Application # ANDA211194
SPL Set ID 99c6a1a9-cadf-435b-a332-ccc189afdfa9
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 ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-10-26
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance DEXTROSE MONOHYDRATE; SODIUM CHLORIDE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 79993002202024
GPI class Dextrose-Sodium Chloride
GCN Seq No 002011
GCN 06950
HICL code 000938
Ingredient (HICL) Dextrose 5 % And 0.3 % Nacl
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%-0.3% NACL IV SOLN
FDB brand name Dextrose 5%-0.3% Nacl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 002011
  • GCN: 06950
  • GPI-14 (Medi-Span): 79993002202024
  • HICL (First Databank): 000938
  • AHFS class code: 40:20.00.00
  • RxCUI (RxNorm): 1795147
Why two NDCs? The FDA registers this code as 63323-867-10 — a 5-3-2 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 product segment → 63323-0867-10. 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.

Clinical

Label name DEXTROSE 5%-0.3% NACL IV SOLN Ingredient Dextrose 5 % And 0.3 % Nacl

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

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 No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · A4216 No ASP payment limit on file for A4216 this quarter.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 250 ml 500 ml
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)63323-867-10
11-digit billing NDC63323-0867-10
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeA4216
DescriptorSTERILE WATER, SALINE AND/OR DEXTROSE, DILUENT/FLUSH, 10 ML
Billing units / pkg0.1 units
How the units are derivedThis package is 1000 ML; the HCPCS unit is 10 ML, so one package = 0.1 billing 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63323-0867-10 You're viewing this Main listing 10 BAG in 1 CASE / 1000 mL in 1 BAG 2020-10-26 — Active
63323-0867-74 63323-867-74 20 BAG in 1 CASE / 500 mL in 1 BAG 2020-10-26 — Active
63323-0867-75 63323-867-75 30 BAG in 1 CASE / 250 mL in 1 BAG 2020-10-26 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 10 bag in 1 case / 1000 ml in 1 bag.
What NDC number is used to bill for this package of Dextrose and Sodium Chloride 5 g/100mL; .3 g/100mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dextrose and Sodium Chloride 5 g/100mL; .3 g/100mL 00990-7925-03 ICU 24 pouches — AP FDA listed —
Dextrose and Sodium Chloride 5 g/100mL; .3 g/100mLthis 63323-0867-10 Fresenius 1000 ml — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2020
On the market since
Oct 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

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 DailyMed — ingredient 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.

Manufacturer & labeler

LabelerFresenius Kabi USA, LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationANDA211194 (ANDA)
Labeler code63323
First marketedOct 2020
Product typeHuman Prescription Drug
Portfolio554 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.

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 ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 32 words ▾

INDICATIONS AND USAGE Intravenous solutions containing dextrose and sodium chloride are indicated for parenteral replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient.

⏱️ Dosage and Administration 99 words ▾

DOSAGE AND ADMINISTRATION The dose is dependent upon the age, weight and clinical condition of the patient. As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

See PRECAUTIONS . Drug Interactions Additives may be incompatible. Consult with pharmacist, if available.

When introducing additives, use aseptic technique, mix thoroughly and do not store.

⛔ Contraindications 3 words ▾

CONTRAINDICATIONS None known.

⚠️ Warnings 126 words ▾

WARNINGS Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. Excessive administration of potassium-free solutions may result in significant hypokalemia. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.

The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.

🤒 Adverse Reactions 65 words ▾

ADVERSE REACTIONS 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.

🔄 Drug Interactions 23 words ▾

Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

🤰 Pregnancy 55 words ▾

Pregnancy Category C. Animal reproduction studies have not been conducted with dextrose or sodium chloride. It is also not known whether dextrose or sodium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose or sodium chloride should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 86 words ▾

Pediatric Use. The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants, the volume of fluid may affect fluid and electrolyte balance.

Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.

🧓 Geriatric Use 113 words ▾

Geriatric Use. An evaluation of current literature revealed no clinical experience identifying differences in response between 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.

Sodium ions are known to be substantially excreted by the kidney, and the risk of toxic reactions 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 26 words ▾

OVERDOSAGE In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS , PRECAUTIONS , and ADVERSE REACTIONS .

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY When administered intravenously, these solutions provide a source of water, carbohydrate and electrolytes. Solutions which provide combinations of hypotonic or isotonic concentrations of dextrose and of sodium chloride are suitable for parenteral maintenance or replacement of water and electrolyte requirements with minimal carbohydrate calories. Solutions containing carbohydrate in the form of dextrose restore blood glucose levels and provide calories.

Carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein-sparing action. Dextrose injected parenterally undergoes oxidation to carbon dioxide and water. Sodium chloride in water dissociates to provide sodium (Na + ) and chloride (Cl¯) ions.

Sodium (Na + ) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl¯) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na + ) and chloride (Cl¯) are largely under the control of the kidney which maintains a balance between intake and output.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirements range from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms.

Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na + ) plays a major role in maintaining physiologic equilibrium.

📦 How Supplied / Storage and Handling 176 words ▾

HOW SUPPLIED Dextrose and Sodium Chloride Injection, USP are supplied in single-dose flexible plastic containers in various sizes as shown in the accompanying Table. Content and Characteristics Grams/100 mL Per 1000 mL Product Code NDC No. Product Dextrose (hydrous) Sodium Chloride Sodium Na + Chloride Cl – Caloric Tonicity Osmolarity mOsmol/L (calc) pH Container 867175 63323-867-75 5% Dextrose and 0.3% Sodium Chloride Inj., USP 5 0.3 51 mEq 51 mEq 170 Hypertonic 355 4.3 (3.5 to 6.5) 250 mL Bag 867174 63323-867-74 5% Dextrose and 0.3% Sodium Chloride Inj., USP 5 0.3 51 mEq 51 mEq 170 Hypertonic 355 4.3 (3.5 to 6.5) 500 mL Bag 867110 63323-867-10 5% Dextrose and 0.3% Sodium Chloride Inj., USP 5 0.3 51 mEq 51 mEq 170 Hypertonic 355 4.3 (3.5 to 6.5) 1000 mL Bag The container closure is not made with natural rubber latex.

Non-PVC, Non-DEHP, Sterile. Protect from freezing. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.].

Manufactured for: Lake Zurich, IL 60047 Made in Germany 451679 www.fresenius-kabi.com/us Issued: September 2020 dexsod-img-02.jpg

📋 Description ~1 min read ▾

DESCRIPTION Dextrose and Sodium Chloride Injection, USP solutions are sterile and nonpyrogenic. They are large volume parenteral solutions containing 5 grams per 100 mL of Dextrose and 0.3 grams per 100 mL of Sodium Chloride in water for injection intended for intravenous administration. See Table for summary of content and characteristics of these solutions.

The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solutions are parenteral fluid, nutrient and electrolyte replenishers.

Dextrose, USP is chemically designated D-glucose monohydrate (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water. It has the following structural formula: Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H 2 O.

The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (free flex ® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period.

The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. dexsod-struc-01.jpg

⚠️ Precautions ~2 min read ▾

PRECAUTIONS Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus. Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions to patients receiving corticosteroids or corticotropin.

Do not administer unless solution is clear and container is undamaged. Discard unused portion. Pregnancy Category C.

Animal reproduction studies have not been conducted with dextrose or sodium chloride. It is also not known whether dextrose or sodium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose or sodium chloride should be given to a pregnant woman only if clearly needed.

Pediatric Use. The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants, the volume of fluid may affect fluid and electrolyte balance.

Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage. Geriatric Use.

An evaluation of current literature revealed no clinical experience identifying differences in response between 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. Sodium ions are known to be substantially excreted by the kidney, and the risk of toxic reactions 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.

📖 Instructions for Use ~1 min read ▾

INSTRUCTIONS FOR USE: Check flexible container solution composition, lot number, and expiry date. Do not remove solution container from its overwrap until immediately before use. Use sterile equipment and aseptic technique.

To Open 1. Turn solution container over so that the text is face down. Using the pre-cut corner tabs, peel open the overwrap and remove solution container.

2. Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution.

3. Do not use if the solution is cloudy or a precipitate is present. To Add Medication 1.

Identify WHITE Additive Port with arrow pointing toward container. 2. Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward container.

3. Hold base of WHITE Additive Port horizontally. 4.

Insert needle horizontally through the center of WHITE Additive Port's septum and inject additives. 5. Mix container contents thoroughly.

For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly. Preparation for Administration 1. Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from container.

2. Use a non-vented infusion set or close the air-inlet on a vented set. 3.

Close the roller clamp of the infusion set. 4. Hold the base of BLUE Infusion Port.

5. Insert spike through BLUE Infusion Port by rotating wrist slightly until the spike is inserted. NOTE: See full directions accompanying administration set.

WARNING: Do not use flexible container in series connections.

📄 Package Label / Principal Display Panel ~1 min read ▾

PACKAGE LABEL – PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 250 mL Bag Label NDC 63323-867-75 free flex ® 250 mL 5% Dextrose and 0.3% Sodium Chloride Injection, USP For intravenous use. Rx only dexsod-label-01.jpg

PACKAGE LABEL – PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 250 mL Case Label NDC 63323-867-75 Product No. 867175 5% Dextrose and 0.3% Sodium Chloride Injection, USP 250 mL x 30 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. dexsod-label-02.jpg

PACKAGE LABEL – PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 500 mL Bag Label NDC 63323-867-74 free flex ® 500 mL 5% Dextrose and 0.3% Sodium Chloride Injection, USP For intravenous use. Rx only dexsod-label-03.jpg

PACKAGE LABEL – PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 500 mL Case Label NDC 63323-867-74 Product No. 867174 5% Dextrose and 0.3% Sodium Chloride Injection, USP 500 mL x 20 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. dexsod-label-04.jpg

PACKAGE LABEL – PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 1000 mL Bag Label NDC 63323-867-10 free flex ® 1000 mL 5% Dextrose and 0.3% Sodium Chloride Injection, USP For intravenous use. Rx only dexsod-label-05.jpg

PACKAGE LABEL – PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 1000 mL Case Label NDC 63323-867-10 Product No. 867110 5% Dextrose and 0.3% Sodium Chloride Injection, USP 1,000 mL x 10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. dexsod-label-06.jpg

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

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 (this brand).

Top reported reactions

Vomiting39
Nausea33
Hyponatraemia27
Ascites26
Constipation26
Sepsis26
Abdominal Distension25

Age at onset

Neonate1
Child7
Adolescent2
Adult16
Elderly11

Reporter sex

165 reports
Male · 55%
Female · 45%

Serious outcomes

Hospitalization107
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.

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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Fresenius Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 250 ml (63323-0867-75), 500 ml (63323-0867-74). 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?
Fresenius Kabi USA, LLC 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 A4216 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.
← 63323-0865-02 · Fresenius 63323-0869-10 · Fresenius →
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.