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Normosol-R and Dextrose Dextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium Chloride 5 g/100mL; 526 mg/100mL; 222 mg/100mL; 502 mg/100mL; 37 mg/100mL; 30 mg/100mL Injection, Solution — NDC 00990-7968-09 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Normosol-R and Dextrose Dextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium Chloride 5 g/100mL; 526 mg/100mL; 222 mg/100mL; 502 mg/100mL; 37 mg/100mL; 30 mg/100mL Injection, Solution — NDC 0990-7968-09 (Billing 00990-7968-09)

by ICU Medical Inc. · 12 BAG in 1 CASE / 1000 mL in 1 BAG

This is a package of Normosol-R and Dextrose Dextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium Chloride 5 g/100mL; 526 mg/100mL; 222 mg/100mL; 502 mg/100mL; 37 mg/100mL; 30 mg/100mL Injection, Solution from ICU Medical Inc., marketed since May 2020 and currently FDA-listed. It is this product's only package size.

NDC 00990-7968-09
🏷️ FDA NDC (as labeled) 0990-7968-09 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

NDC database record

One package, one record: these facts belong to NDC 0990-7968-09 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0990 labeler · 7968 product · 09 package
Package marketed since
May 14, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0990796809 4
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0990-7968-09
Product NDC 0990-7968
11-digit billing NDC 00990796809
NCPDP billing unit ML — per mL (volume)
RxCUI 801024, 1189629
UNII LX22YL083G, 451W47IQ8X, NVG71ZZ7P0, R6Q3791S76, 660YQ98I10, 02F3473H9O
Application # NDA017609
SPL Set ID ead1fca3-eff4-478f-8a8f-67510f80151a
Established class (EPC) Calculi Dissolution Agent; Inhibition L
Physiologic effect Increased Large Intestinal Motility
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-05-14
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM GLUCONATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE

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

GPI-14 79993002872010
GPI class Normosol-R in D5W
GCN Seq No 001961
GCN 62201
HICL code 014863
Ingredient (HICL) Electrolyte-R Solution/D5W
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C1
Therapeutic class — intermediate (HIC2) Drugs Affecting Electrolyte Balance
HIC3 code C1W
Therapeutic class — specific (HIC3) Electrolyte Maintenance
AHFS code 40:12.00.00
AHFS class Replacement Preparations
FDB label name NORMOSOL-R-DEXTROSE 5% IV SOLN
FDB brand name Normosol-R And Dextrose
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 001961
  • GCN: 62201
  • GPI-14 (Medi-Span): 79993002872010
  • HICL (First Databank): 014863
  • AHFS class code: 40:12.00.00
  • RxCUI (RxNorm): 801024
Why two NDCs? The FDA registers this code as 0990-7968-09 — 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 → 00990-7968-09. 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 NORMOSOL-R-DEXTROSE 5% IV SOLN Ingredient Electrolyte-R Solution/D5W

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.
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.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00990-7968-09 You're viewing this Main listing 12 BAG in 1 CASE / 1000 mL in 1 BAG 2020-05-14 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Normosol-R and Dextrose 5 g/100mL; 526 mg/100mL; 222 mg/100mL; 502 mg/100mL; 37 mg/100mL; 30 mg/100mLthis 00990-7968-09 ICU 1000 ml — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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
May 2020
📍
2026
Currently FDA-listed
6 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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 QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 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.

2 inactive ingredients 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

LabelerICU Medical Inc.
Application holderOTSUKA ICU MEDICAL LLC
FDA applicationNDA017609 (NDA)
Labeler code00990
First marketedMay 2020
Product typeHuman Prescription Drug
Portfolio48 products on file

More NDCs from ICU Medical Inc. labeler code 00990

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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 76 words ▾

INDICATIONS AND USAGE Normosol-R and 5% Dextrose Injection is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. Normosol-R and 5% Dextrose also can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss. The solution is not intended to supplant transfusion of whole blood or packed red cells in the presence of uncontrolled hemorrhage or severe reductions of red cell volume.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION Normosol-R and 5% Dextrose Injection is administered by intravenous infusion. The amount to be infused is based on replacement of losses of extracellular fluid volume in the individual patient. Up to 3 times the volume of estimated blood loss during and after surgery can be given to correct circulatory volume when there is only a moderate loss of blood.

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

When introducing additives, use aseptic technique, mix thoroughly and do not store. Normosol-R and 5% Dextrose solution does not contain calcium to avoid precipitation of calcium salts that may occur when certain drugs are added. Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit.

(See PRECAUTIONS .) INSTRUCTIONS FOR USE To Open: Tear outer wrap at notch and remove solution 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.

If supplemental medication is desired, follow directions below before preparing for administration. To Add Medication Prepare additive port. Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject.

Withdraw needle after injecting medication. The additive port may be protected by covering with an additive cap. Mix container contents thoroughly.

To Administer Attach administration set per manufacturer’s instructions. Regulate rate of administration per institutional policy. WARNING: Do not use flexible container in series connections.

⛔ Contraindications 3 words ▾

CONTRAINDICATIONS None known.

⚠️ Warnings ~1 min read ▾

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. Solutions which contain potassium should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present. In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention.

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 during fluid replacement with Normosol-R and 5% Dextrose. Solutions containing acetate or gluconate ions should be used with great care in patients with metabolic or respiratory alkalosis. Acetate or gluconate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of these ions, such as severe hepatic insufficiency.

The intravenous administration of this solution can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. Elderly patients may be at increased risk for the development of fluid overloading and dilutional hyponatremia following Normosol-R and 5% Dextrose administration. 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.

🤰 Pregnancy 52 words ▾

Pregnancy Category C Animal reproduction studies have not been conducted with Normosol-R and 5% Dextrose Injection. It is also not known whether this solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This solution 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 175 words ▾

Geriatric Use Clinical studies of Normosol-R and 5% Dextrose did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified 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.

Elderly patients have been shown to secrete higher levels of antidiuretic hormone than younger patients, which may increase the risk of fluid overloading, and dilutional hyponatremia in these patients. (See WARNINGS .) 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.

(See WARNINGS .)

🆘 Overdosage 25 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 ~3 min read ▾

CLINICAL PHARMACOLOGY When administered intravenously, Normosol-R and 5% Dextrose Injection provides water and electrolytes with carbohydrate calories for replacement of acute extracellular fluid losses without disturbing normal electrolyte relationships. The electrolyte composition approaches that of the principal ions of normal plasma (extracellular fluid). The electrolyte concentration is approximately isotonic in relation to the extracellular fluid (approx.

280 mOsmol/liter) and provides a physiologic sodium to chloride ratio, normal plasma concentrations of potassium and magnesium and two bicarbonate alternates, acetate and gluconate. Dextrose provides minimal calories and renders the solution hypertonic. Solutions containing carbohydrate in the form of dextrose restore blood glucose levels and supply 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.

Potassium chloride in water dissociates to provide potassium (K + ) and chloride (Cl‾) ions. Potassium is the chief cation of body cells (160 mEq/liter of intracellular water). It is found in low concentration in plasma and extracellular fluids (3.5 to 5.0 mEq/liter in a healthy adult and child over 10 days old; 3.5 to 6.0 mEq/liter in a child less than 10 days old).

Potassium plays an important role in electrolyte balance. Normally about 80 to 90% of the potassium intake is excreted in the urine; the remainder in the stools and to a small extent, in the perspiration. The kidney does not conserve potassium well so that during fasting or in patients on a potassium-free diet, potassium loss from the body continues resulting in potassium depletion.

Magnesium chloride in water dissociates to provide magnesium (Mg ++ ) and chloride (Cl‾) ions. Magnesium is the second most plentiful cation of the intracellular fluids. It is an important cofactor for enzymatic reactions and plays an important role in neurochemical transmission and muscular excitability.

Normal plasma concentration ranges from 1.5 to 2.5 or 3.0 mEq per liter. Magnesium is excreted solely by the kidney at a rate proportional to the plasma concentration and glomerular filtration. Sodium acetate provides sodium (Na + ) and acetate (CH 3 COO‾) ions, the latter anion (a source of hydrogen ion acceptors) serving as an alternate source of bicarbonate (HCO 3 ‾) by metabolic conversion in the liver.

This has been shown to proceed readily even in the presence of severe liver disease. Thus, acetate anion exerts a mild systemic antiacidotic action that may be advantageous during fluid and electrolyte replacement therapy. Sodium gluconate provides sodium (Na + ) and gluconate (C 6 H 11 0 7 ‾) ions.

Although gluconate is a theoretical alternate metabolic source of bicarbonate (HC0 3 ‾) anion, a significant antiacidotic action has not been established. Thus, the gluconate anion serves primarily to complete the cation-anion balance of the solution. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight.

Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Average normal pediatric daily requirements are based on the child’s weight as described in the table below: Weight Fluid Requirements Up to 10 kg 100… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 164 words ▾

HOW SUPPLIED Normosol-R and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is supplied in a 1000 mL single-dose flexible plastic container (NDC No. 0409–7968–09 and 0990-7968-09). ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code.

Both NDC codes are expected to be in the market for a period of time. TABLE Electrolyte Content, Caloric Value and Characteristics Milliequivalents per Liter HC0 - 3 (alternates) Cal* mOsmol/L Tonicity Na + K + Mg ++ Cl - Acetate Gluconate per Liter (calc.) (total contents) pH Normosol-R and 5% Dextrose 140 5 3 98** 27 23 185 547 Hypertonic 5.2 (4.0 to 6.5) * Normosol-R and 5% Dextrose calories derived from dextrose (170) and gluconate (15). **Not including hydrochloric acid. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. ® Normosol − multiple electrolyte solution, ICU Medical, Inc.

Revised: March, 2020 IFU0000172 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

📋 Description ~2 min read ▾

DESCRIPTION Normosol-R and 5% Dextrose Injection is a sterile, nonpyrogenic solution of balanced electrolytes (with dextrose) in water for injection. The solution is administered by intravenous infusion for parenteral replacement of acute losses of extracellular fluid (with minimal carbohydrate calories). Each 100 mL of Normosol-R and 5% Dextrose Injection contains dextrose 5 g; sodium chloride 526 mg; sodium acetate, anhydrous 222 mg; sodium gluconate 502 mg; potassium chloride 37 mg; magnesium chloride, hexahydrate 30 mg; pH adjusted with hydrochloric acid.

See TABLE for summary of electrolyte content, caloric value and characteristics of this solution. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded.

Normosol-R and 5% Dextrose Injection is a parenteral fluid, electrolyte and nutrient replenisher. Dextrose, USP is chemically designated D-glucose monohydrate (C 6 H 12 O 6 • H 2 0), 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.

Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Magnesium Chloride, USP is chemically designated magnesium chloride hexahydrate (MgCl 2 • 6H 2 O) deliquescent crystals very soluble in water. Sodium Acetate, USP, is chemically designated sodium acetate anhydrous (C 2 H 3 NaO 2 ), a hygroscopic powder soluble in water.

It has the following structural formula: Sodium gluconate is chemically designated C 6 H 11 NaO 7 , the normal sodium salt of gluconic acid soluble in water. It has the following structural formula: Water for Injection, USP is chemically designated H 2 0. The flexible plastic container is fabricated from a specially formulated polyvinylchloride.

Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content.

Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. structural formula dextrose USP structural formula sodium acetate usp structural formula sodium gluconate

⚠️ Precautions ~2 min read ▾

PRECAUTIONS Normosol-R and 5% Dextrose Injection should be used with caution in severe renal impairment because of the danger of hyperkalemia. As with all intravenous solutions, care should be taken to avoid circulatory overload, especially in patients with cardiac or pulmonary disorders. Normosol-R and 5% Dextrose is not intended to correct acidosis or large deficits of individual electrolytes, nor to replace blood or plasma expanders when these are indicated.

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. Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin. Solutions containing acetate or gluconate ions should be used with caution, as excess administration may result in metabolic alkalosis.

Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus. 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 Normosol-R and 5% Dextrose Injection. It is also not known whether this solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This solution 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 Clinical studies of Normosol-R and 5% Dextrose did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified 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. Elderly patients have been shown to secrete higher levels of antidiuretic hormone than younger patients, which may increase the risk of fluid overloading, and dilutional hyponatremia in these patients. (See WARNINGS .) 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. (See WARNINGS .)

📄 Package Label / Principal Display Panel 173 words ▾

PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label 1000 mL NDC 0990-7968-09 NORMOSOL ® -R and 5% DEXTROSE Inj. MULTIPLE ELECTROLYTES AND 5% DEXTROSE INJECTION TYPE 1, USP EACH 100 mL CONTAINS DEXTROSE, HYDROUS 5 g; SODIUM CHLORIDE 526 mg; SODIUM ACETATE, ANHYD. 222 mg; SODIUM GLUCONATE 502 mg; POTASSIUM CHLORIDE 37 mg; MAGNESIUM CHLORIDE, HEXAHYDRATE 30 mg IN WATER FOR INJECTION. pH ADJUSTED WITH HCl.

ELECTROLYTES PER 1000 mL (NOT INCLUDING pH ADJUSTMENT): SODIUM 140 mEq; POTASSIUM 5 mEq; MAGNESIUM 3 mEq; CHLORIDE 98 mEq; ACETATE 27 mEq; GLUCONATE 23 mEq. 547 mOsmol/LITER (CALC). pH 5.2 (4.0 to 6.5) ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE.

WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR (IV) USE.

USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED.

MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 3 v CONTAINS DEHP IMP0000055 icumedical ICU Medical, Inc., Lake Forest, Illinois, 60045, USA PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label

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

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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
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 ICU Medical Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
ICU Medical Inc. 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.
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.
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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.