NDC 0990-7965-09 (00990-7965-09) — NORMOSOL-M AND DEXTROSE dextrose

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0990-7965-09

Product NDC 0990-7965

11-digit billing NDC 00990796509

NCPDP billing unit ML — per mL (volume)

RxCUI 801005, 801009

UNII LX22YL083G, 451W47IQ8X, M911911U02, 0E95JZY48K

Application # NDA017610

SPL Set ID aba60c84-94d9-46d0-bdbb-25e0c4e8cc41

Established class (EPC) Calculi Dissolution Agent; Inhibition Large Intestine Fluid/E

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 2021-02-08

Route INTRAVENOUS

Dosage form INJECTION, SOLUTION

Substance DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM ACETATE; MAGNESIUM ACETATE

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

GPI-14 79993002752010

GPI class Normosol-M in D5W

GCN Seq No 001960

GCN 62540

HICL code 014861

Ingredient (HICL) Electrolyte-M 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-M-DEXTROSE 5% IV SOLN

FDB brand name Normosol-M And Dextrose

Legend status F — Federal legend — prescription drug or device

Quick answers

GSN (GCN sequence number): 001960
GCN: 62540
GPI-14 (Medi-Span): 79993002752010
HICL (First Databank): 014861
AHFS class code: 40:12.00.00
RxCUI (RxNorm): 801005

Why two NDCs? The FDA registers this code as 0990-7965-09 — 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 → 00990-7965-09. 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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 6, 2026
RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
Medi-Span GPI (licensed)
First Databank (licensed) · refreshed Oct 1, 2026

Clinical

Label name NORMOSOL-M-DEXTROSE 5% IV SOLN Ingredient Electrolyte-M Solution/D5W

Patient education

📘 MedlinePlus patient leaflet ↗

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.

MedlinePlus (NLM) · refreshed Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 6, 2026

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	$12.71	$152,570.40 / 12000 ml
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?

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.

CMS NADAC weekly file
CMS ASP pricing files · refreshed Sep 20, 2026
CMS Medicaid State Drug Utilization Data · through Q1 2026
CMS Part D plan pricing files · refreshed Sep 24, 2026
VA National Acquisition Center price file

Packaging — all sizes for this product

Package NDC	Description	Marketing start	Marketing end	Status
00990-7965-09 You're viewing this Main listing	12 POUCH in 1 CASE / 1 BAG in 1 POUCH / 1000 mL in 1 BAG	2021-02-08	—	Active

Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Normosol-M And Dextrose 5 g/100mL; 234 mg/100mL; 128 mg/100mL; 21 mg/100mLthis 00990-7965-09	ICU	12 pouches	—	—	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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA Orange Book · refreshed Oct 3, 2026
CMS NADAC weekly file

Availability & generic status

🏛️

2021

On the market since

Feb 2021

📍

2026

Currently FDA-listed

5 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.

FDA Orange Book · refreshed Oct 3, 2026

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.

FDA label on DailyMed · label index refreshed Oct 6, 2026
FDA openFDA NDC Directory · synced Oct 1, 2026

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 applicationNDA017610 (NDA)

Labeler code00990

First marketedFeb 2021

Product typeHuman Prescription Drug

Portfolio48 products on file

More NDCs from ICU Medical Inc. labeler code 00990

🔎 All NDCs from ICU Medical Inc.

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.

FDA openFDA NDC Directory · synced Oct 1, 2026
Drugs@FDA

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 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel

🎯 Indications and Usage 52 words ▾

INDICATIONS AND USAGE Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is indicated for parenteral maintenance of routine daily fluid and electrolyte requirements with minimal carbohydrate calories from dextrose. Magnesium in the formula may help to prevent iatrogenic magnesium deficiency in patients receiving prolonged parenteral therapy.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION Normosol-M and 5% Dextrose Injection is administered by intravenous infusion. The dose is dependent upon the age, weight and clinical condition of the patient. A daily total amount of 1500 mL/M 2 of body surface will meet the usual adult daily requirements for water and principal electrolytes in patients unable to take anything by mouth.

The usual daily maintenance amount for an average adult (70 kg and 1.8 square meters of body surface) is approximately three liters. 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. To avoid precipitation of calcium salts that may occur when certain drugs are added, Normosol-M and 5% Dextrose Injection does not contain calcium.

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 3 words ▾

CONTRAINDICATIONS None known.

⚠️ Warnings 185 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. 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.

Solutions containing acetate should be used with great care in patients with metabolic or respiratory alkalosis, and in those conditions in which there is an increased level or an impaired utilization of acetate, such as severe hepatic insufficiency. Administration of this solution 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.

🤰 Pregnancy 52 words ▾

Pregnancy Category C. Animal reproduction studies have not been conducted with Normosol-M 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 63 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 and 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.

🆘 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-M and 5% Dextrose Injection provides water and electrolytes (with dextrose as a readily available source of carbohydrate) for maintenance of daily fluid and electrolyte requirements, plus minimal carbohydrate calories. The electrolyte composition approaches that of the principal ions of normal plasma (extracellular fluid). The electrolyte concentration is hypotonic (112 mOsmol/liter) in relation to the extracellular fluid (280 mOsmol/liter).

One liter provides approximately one-third of the average adult daily requirement for water and principal electrolytes in balanced proportions, with acetate as a bicarbonate alternate, plus 170 calories from dextrose. 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 in 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 acetate in water dissociates to provide potassium (K + ) and acetate (CH 3 COO − ) 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 acetate in water dissociates to provide magnesium (Mg ++ ) and acetate (CH 3 COO − ) 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. Acetate anion (CH 3 COO − ), a source of hydrogen ion acceptors, serves 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. 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 147 words ▾

HOW SUPPLIED Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is supplied in single-dose flexible plastic containers. NDC No. Product Container Size (mL) 0409-7965-03 Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Inj., Type 1, USP) 500 0990-7965-03 Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Inj., Type 1, USP) 500 0409-7965-09 Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Inj., Type 1, USP) 1000 0990-7965-09 Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Inj., Type 1, USP) 1000 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. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Revised: March, 2020 IFU0000171 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

📋 Description ~2 min read ▾

DESCRIPTION Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is a sterile, nonpyrogenic, hypertonic solution of balanced maintenance electrolytes and 5% dextrose injection in water for injection. The solution is administered by intravenous infusion for parenteral maintenance of routine daily fluid and electrolyte requirements with minimal carbohydrate calories. Each 100 mL contains dextrose, hydrous 5 g, sodium chloride, 234 mg, potassium acetate, 128 mg and magnesium acetate, anhydrous 21 mg.

May contain hydrochloric acid for pH adjustment. The electrolyte content (not including hydrochloric acid) and other characteristics are as follows: Sodium (Na + ) 40 mEq/liter Potassium (K + ) 13 mEq/liter Magnesium (Mg ++ ) 3 mEq/liter Chloride (Cl − ) 40 mEq/liter Bicarbonate (HCO 3 − ) as acetate 16 mEq/liter Caloric value (dextrose) 170 Calories/liter Tonicity Hypertonic Osmolarity 363 mOsmol/liter (calc.) pH (range) 5.0 (4.0 to 6.5) 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-M 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 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. Potassium Acetate, USP is chemically designated CH 3 COOK, colorless crystals or white crystalline powder very soluble in water. Magnesium acetate is chemically designated Mg (C 2 H 3 O 2 ) 2 , colorless or white crystals very soluble in water.

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 dextrose

⚠️ Precautions ~1 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. Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin. Solutions containing acetate 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.

In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage. Pregnancy Category C. Animal reproduction studies have not been conducted with Normosol-M 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 and 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.

📄 Package Label / Principal Display Panel 164 words ▾

PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label 1000 mL NDC 0990-7965-09 NORMOSOL ® -M AND 5% DEXTROSE INJECTION MULTIPLE ELECTROLYTES AND 5% DEXTROSE INJECTION TYPE 1, USP EACH 100 mL CONTAINS DEXTROSE, HYDROUS 5 g; SODIUM CHLORIDE 234 mg; POTASSIUM ACETATE 128 mg; MAGNESIUM ACETATE, ANHYDROUS 21 mg IN WATER FOR INJECTION. MAY CONTAIN HYDROCHLORIC ACID FOR pH ADJUSTMENT. ELECTROLYTES PER 1000 mL (NOT INCLUDING pH ADJUSTMENT); SODIUM 40 mEq; POTASSIUM 13 mEq; MAGNESIUM 3 mEq; CHLORIDE 40 mEq; ACETATE 16 mEq.

363 mOsmol/LITER (CALC). pH 5.0 (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. USUAL DOSAGE: SEE INSERT. FOR I.V.

USE. 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 IMP0000054 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icumedical PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label

Glossary — plain-language definitions of medical terms used in this label:

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

edema: Swelling caused by extra fluid trapped in the body's tissues.

electrolyte: A mineral in the blood and body fluids, such as sodium, potassium, or calcium, that carries a small electric charge and helps the body work.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

extravasation: The accidental leaking of an injected medicine out of the vein into the surrounding tissue, which can cause pain, swelling, or tissue damage.

febrile: Having a fever, or relating to a fever.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

hyperglycemia: High blood sugar, meaning there is more glucose (sugar) in the blood than normal.

hyperkalemia: A higher-than-normal level of potassium, an important mineral, in the blood.

hypoglycemia: Low blood sugar, when the amount of glucose (sugar) in the blood drops below the normal range.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

parenteral: Given by injection or drip into the body rather than swallowed by mouth.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

pregnancy category: An older letter rating (A, B, C, D, or X) once used to describe a medicine's possible risk during pregnancy.

pulmonary edema: A buildup of fluid in the lungs' air sacs that makes it hard to breathe.

Rx only: A label marking meaning the medicine can be obtained only with a prescription from a licensed health professional.

thrombosis: The forming of a blood clot inside a blood vessel, which can block normal blood flow.

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

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 this package alone, 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.

📅 Q2 2025 – Q1 2026 · 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

30

Units reimbursed last 4 qtrs

26

Gross reimbursed last 4 qtrs

$330.57

Avg / prescription

$11.02

Avg / unit

$12.7142

Latest quarter Q1 2026

18Rx

Fee-for-service vs managed care ⓘ

100% MCO

Fee-for-service · 0 Rx Managed care · 30 Rx

State Medicaid map

Units reimbursed · per 100k residents

0.60.6

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 Kentucky 0.6 /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.

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)	✓ 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 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.

Related NDC lookups

🧪 All Dextrose Monohydrate, Sodium Chloride, Potassium Acetate, And Magnesium Acetate NDCsSame ingredient 🏭 All ICU labeler NDCsLabeler code 00990 📚 All Calculi Dissolution Agent NDCsDrug class

Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Electrolyte Maintenance.

Electrolyte-S Solution 00264-7703-00 Electrolyte-S (Ph 7.4) 00264-7707-00 Electrolyte-P Solution/D5W 00264-7730-10 Ringer's Solution,Lactated 00264-7750-00 Ringer's Solution 00264-7780-00 Electrolyte-48 Solution/D5W 00338-0143-03 Electrolyte-148 Solution 00338-0179-03 Electrolyte-A Solution 00338-0221-03 Electrolyte-148 (Ph 7.4) 00338-9593-10 Sodium/Pot/Mag/Calc/Chlor/Acet 00409-5779-01 Electrolyte-Mb Solution/D5W 00990-7372-03 Electrolyte-R (Ph 7.4) 00990-7670-03 Electrolyte-R Solution 00990-7967-09 Electrolyte-R Solution/D5W 00990-7968-09

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

First Databank (licensed) · refreshed Oct 1, 2026

NORMOSOL-M AND DEXTROSE dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate 5 g/100mL; 234 mg/100mL; 128 mg/100mL; 21 mg/100mL Injection, Solution — NDC 0990-7965-09 (Billing 00990-7965-09)

NDC database record

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

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

Clinical

Patient education

Supplement & herbal interactions

Pricing

Packaging — all sizes for this product

Therapeutic equivalents

Availability & generic status

Inactive Ingredients / Excipients

Inactive ingredient FAQ

Manufacturer & labeler

More NDCs from ICU Medical Inc. labeler code 00990

Full prescribing information FDA SPL

Medicaid utilization & spend

About this NDC listing & data coverage

Questions about this listing