Normosol-R SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE 526 mg/100mL; 222 mg/100mL; 502 mg/100mL; 37 mg/100mL; 30 mg/100mL Injection, Solution
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Electrolyte solutions class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- This solution is replacing fluids and essential minerals your body lost — for example, during surgery, an injury, or a serious illness. Think of it as restoring your body's interna...
- Why am I getting this IV fluid — what is it actually doing for me?
- It's similar, but not identical. Regular saline (0.9% sodium chloride) only contains sodium and chloride. These electrolyte solutions also include potassium, magnesium, and other c...
- Is this the same as a regular saline drip?
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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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.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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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.
3 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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?
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💲 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 system | Per mL | Per 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. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Normosol-R 526 mg/100mL; 222 mg/100mL; 502 mg/100mL; 37 mg/100mL; 30 mg/100mLthis 00990-7670-03 | ICU | 500 ml | — | — | FDA listed | — |
| Normosol-R 526 mg/100mL; 222 mg/100mL; 502 mg/100mL; 37 mg/100mL; 30 mg/100mL 00990-7967-09 | ICU | 12 pouches | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
💊 Medicaid utilization by pack size
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00990-7670-03 You're viewing this | 24 BAG in 1 CASE (0990-7670-03) / 500 mL in 1 BAG | 2019-12-31 | Active |
| 00990-7670-09 | 12 BAG in 1 CASE (0990-7670-09) / 1000 mL in 1 BAG | 2019-09-01 | Active |
This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓
Pack size FAQ
What quantity is in NDC 00990-7670-03?
What NDC number is used to bill for this package of Normosol-R SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE 526 mg/100mL; 222 mg/100mL; 502 mg/100mL; 37 mg/100mL; 30 mg/100mL Injection, Solution?
🧭 About this NDC listing & data coverage
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. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Normosol-R pH 7.4 is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. Normosol-R pH 7.4 also can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss. Normosol-R pH 7.4 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.
Normosol-R pH 7.4 is particularly valuable as a solution for use in starting blood, i.e., as a priming solution for the infusion set. No hemolysis of blood is seen at the interface or with mixed solution and blood. It may also be used as a diluent to aid in the transfusion of packed red blood cells (PRBC).
Normosol-R pH 7.4 and physiologic saline solution (0.9% Sodium Chloride Injection, USP) are compatible with both young and old PRBC.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Normosol-R pH 7.4 is administered by intravenous infusion. It may also be administered subcutaneously. The amount to be infused is based on replacement of losses of extracellular fluid volume in the individual patient.
Up to three 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. 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.
The opacity will diminish gradually. 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 ▾
CONTRAINDICATIONS None known.
⚠️ Warnings ▾
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. 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 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 ▾
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 ▾
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 pH 7.4 does not contain calcium to avoid precipitation of calcium salts that may occur when certain drugs are added. Solutions which contain calcium in amounts exceeding the normal plasma concentration may enhance clotting on contact with citrated blood. Hence, Normosol-R pH 7.4 can be used for starting a blood transfusion.
🤰 Pregnancy ▾
Pregnancy Category C. Animal reproduction studies have not been conducted with Normosol-R pH 7.4. 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 ▾
Pediatric Use. The safety and effectiveness of Normosol-R pH 7.4 have been established in the age groups of birth to 16 years. Use of Normosol-R pH 7.4 is supported by evidence from adequate and well-controlled clinical studies in adults with additional data from post-marketing experience in the pediatric population.
🧓 Geriatric Use ▾
Geriatric Use: Clinical studies of Normosol-R 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 ▾
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 ▾
CLINICAL PHARMACOLOGY When administered intravenously, Normosol-R pH 7.4 provides water and electrolytes 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. 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 O 7 − ) ions. Although gluconate is a theoretical alternate metabolic source of bicarbonate (HCO 3 − ) anion, a significant antiacidotic action has not been established.
Thus, the gluconate anion serves primarily to complete the cation-anion balance of the solutions. 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 mL/kg 11 to 20 kg 1,000 mL + 50 mL/kg for each kg above 10 kg Above 20 kg 1,500 mL + 20 mL/kg for each kg above 20 kg 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 ▾
HOW SUPPLIED Normosol-R pH 7.4 (Multiple Electrolytes Injection Type 1, USP) is supplied in 500 and 1000 mL single-dose flexible plastic containers NDC 0409-7670-03 Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA NDC 0990-7670-03 , NDC 0409-7670-09 Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USA , NDC 0990-7670-09 , ICU Medical is transitioning NDC from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. Exposure of pharmaceutical products to heat should be minimized.
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Revised: August, 2020 IFU0000259
📋 Description ▾
DESCRIPTION Normosol ® -R pH 7.4 is a sterile, nonpyrogenic, isotonic solution of balanced electrolytes in water for injection. The solution is administered by intravenous infusion for parenteral replacement of acute losses of extracellular fluid. Each 100 mL of Normosol-R pH 7.4 contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride, hexahydrate 30 mg.
May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH range 6.5 to 7.6; 295 mOsmol/liter (calc.). 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. 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 pH 7.4 is a parenteral fluid and electrolyte replenisher. 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 O. The flexible plastic container is fabricated from a specially formulated polyvinyl chloride.
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 sodium acetate structural formula sodium gluconate