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Dextrose 10 g/100mL Injection, Solution, Concentrate — NDC 00990-7938-19 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dextrose 10 g/100mL Injection, Solution, Concentrate — NDC 0990-7938-19 (Billing 00990-7938-19)

by ICU Medical, Inc. · 12 POUCH in 1 CASE / 1 BAG in 1 POUCH / 500 mL in 1 BAG

This is a package of Dextrose 10 g/100mL Injection, Solution, Concentrate from ICU Medical, Inc., marketed since Nov 2019 and currently FDA-listed. It is this product's only package size.

NDC 00990-7938-19
🏷️ FDA NDC (as labeled) 0990-7938-19 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⚠ On shortage ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 0990-7938-19 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0990 labeler · 7938 product · 19 package
Package marketed since
Nov 20, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0990793819 6
FDA record last changed
Jul 24, 2026
⚠️
Active FDA shortage. Dextrose Monohydrate 10% Injection is currently reported in shortage by the FDA (Discontinuation of the manufacture of the drug). Unavailable Shortage details →
⚠️
Other active recalls for Dextrose Monohydrate (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0435-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0437-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0436-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0990-7938-19
Product NDC 0990-7938
11-digit billing NDC 00990793819
NCPDP billing unit ML — per mL (volume)
RxCUI 1795477
UNII LX22YL083G
Application # NDA018080
SPL Set ID cb578dba-094c-4787-951d-763d12fd06e1
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-11-20
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION, CONCENTRATE
Substance DEXTROSE MONOHYDRATE
TE code (Orange Book) AP · RLD · RS

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

GPI-14 80100020002020
GPI class Dextrose
GCN Seq No 001978
GCN 06671
HICL code 000918
Ingredient (HICL) Dextrose 10 % In Water
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C5
Therapeutic class — intermediate (HIC2) Carbohydrates And/Or Proteins
HIC3 code C5J
Therapeutic class — specific (HIC3) Iv Solutions: Dextrose-Water
AHFS code 40:20.00.00
AHFS class Caloric Agents
FDB label name DEXTROSE 10%-WATER IV SOLUTION
FDB brand name Dextrose In Water
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 001978
  • GCN: 06671
  • GPI-14 (Medi-Span): 80100020002020
  • HICL (First Databank): 000918
  • AHFS class code: 40:20.00.00
  • RxCUI (RxNorm): 1795477
Why two NDCs? The FDA registers this code as 0990-7938-19 — 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 → 00990-7938-19. 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 10%-WATER IV SOLUTION Ingredient Dextrose 10 % In Water
📗 Our plain-language guide HelloPharmacist
  • Dextrose is essentially the same glucose your body gets from food, but in this case it's going directly into the bloodstream. That's important in two main situations: when blood su...
  • Why is my loved one being given dextrose through an IV — isn't sugar just food?
  • Yes, that's a real concern. Dextrose raises blood glucose, which is exactly what you need when blood sugar is too low. But if it's given too fast or in too high a concentration, it...
  • Can dextrose actually cause high blood sugar? I thought it was for low blood sugar.
📖 Read our full Dextrose guide →

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 · Q2 2026 $0.0200 $120.00 / 6000 ml
Medicare Part B allowsASP · A4216 No ASP payment limit on file for A4216 this quarter.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)0990-7938-19
11-digit billing NDC00990-7938-19
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler 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 500 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
00990-7938-19 You're viewing this Main listing 12 POUCH in 1 CASE / 1 BAG in 1 POUCH / 500 mL in 1 BAG 2019-11-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dextrose 10 g/100mL 00264-7520-00 B. 1000 ml — AP FDA listed —
Dextrose 100 g/1000mL 00338-0023-02 Baxter 250 ml — AP FDA listed —
Dextrose 10 g/100mL 00990-7930-02 ICU 24 pouches — AP FDA listed —
Dextrose 10 g/100mLthis 00990-7938-19 ICU 12 pouches — AP FDA listed —
Dextrose 100 mg/mL 17271-0721-05 Becton 250 ml — AP FDA listed —
Dextrose 100 mg/mL 63323-0824-74 Fresenius 250 ml — AP FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2019
On the market since
Nov 2019
📍
2026
Currently FDA-listed
7 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

🧪 Avoiding an ingredient? See Dextrose inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 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

LabelerICU Medical, Inc.
Application holderOTSUKA ICU MEDICAL LLC
FDA applicationNDA018080 (NDA)
Labeler code00990
First marketedNov 2019
Product typeHuman Prescription Drug
Portfolio5 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. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 46 words ▾

INDICATIONS AND USAGE 10% Dextrose Injection, USP (concentrated dextrose in water) in a partial-fill container is indicated for admixture with amino acids or dilution with other compatible IV fluids to provide a 5% final dextrose concentration for intravenous infusion in patients whose condition requires parenteral nutrition.

⏱️ Dosage and Administration 203 words ▾

DOSAGE AND ADMINISTRATION Concentrated Dextrose in Water is administered by slow intravenous infusion (a) after admixture with amino acid solutions or (b) after dilution with other compatible IV fluids. Dosage should be adjusted to meet the requirements of each individual patient. The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg of body weight /hr.

About 95% of the dextrose is retained when infused at a rate of 0.8 g/kg/hr. 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. A list of nutritional admixture values is appended.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS ). Drug Interaction Additives may be incompatible.

Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Some opacity of the plastic due to moisture absorption during sterilization process may be observed.

This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. WARNING: Do not use flexible container in series connections.

⛔ Contraindications 57 words ▾

CONTRAINDICATIONS A concentrated dextrose solution should not be used when intracranial or intraspinal hemorrhage is present nor in the presence of delirium tremens if the patient is already dehydrated. Dextrose Injection, USP without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur.

⚠️ Warnings ~1 min read ▾

WARNINGS Concentrated dextrose in water should be administered only after suitable dilution. Hypertonic dextrose solutions should be given slowly. Significant hyperglycemia and possible hyperosmolar syndrome may result from too rapid administration.

The physician should be aware of the symptoms of hyperosmolar syndrome, such as mental confusion and loss of consciousness, especially in patients with chronic uremia and those with known carbohydrate intolerance. 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. WARNING : This product contains aluminum that may be toxic.

Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity.

Tissue loading may occur at even lower rates of administration. FOR PERIPHERAL VEIN ADMINISTRATION Hypertonic dextrose solutions (above 5% concentration) should be given slowly, preferably through a small bore needle into a large vein, to minimize venous irritation. FOR CENTRAL VENOUS ADMINISTRATION Concentrated dextrose should be administered via central vein after appropriate admixture or dilution when required.

🤒 Adverse Reactions 85 words ▾

ADVERSE REACTIONS Hyperosmolar syndrome, resulting from excessively rapid administration of concentrated dextrose may cause hypovolemia, dehydration, mental confusion and/or loss of consciousness. 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 64 words ▾

Drug Interaction Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Some opacity of the plastic due to moisture absorption during sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. WARNING: Do not use flexible container in series connections.

🤰 Pregnancy 56 words ▾

Pregnancy Category C. Animal reproduction studies have not been conducted with dextrose. It is also not known whether dextrose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose should be given to a pregnant woman only if clearly needed. This product contains no more than 25 mcg/L of aluminum.

🆘 Overdosage 24 words ▾

OVERDOSAGE In the event of overhydration or solute overload during therapy, re-evaluate the patient and institute appropriate corrective measures. (See WARNINGS and PRECAUTIONS ).

🧬 Clinical Pharmacology 127 words ▾

CLINICAL PHARMACOLOGY When administered intravenously, 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 Injection, USP undergoes oxidation to carbon dioxide and water.

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, respectively). 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 186 words ▾

HOW SUPPLIED 10% Dextrose Injection, USP is supplied in single-dose, partial-fill, flexible containers as follows: a 500 mL volume in a 1000 mL container. See the following table. Concentrated Dextrose In Water Content and Characteristics NDC No. % Conc.

Fill Volume (mL) Total Grams of Dextrose Hydrous Per Container kcal Caloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous. /100 mL (Per Container) mOsmol/liter (calc.) pH (range) 0409-7938-19 10 500 50 34 (170) 505 4.3 (3.2 to 6.5) 0990-7938-19 10 500 50 34 (170) 505 4.3 (3.2 to 6.5) 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. Nutritional Admixture Values Equal volumes of 10% Dextrose Injection, USP and Aminosyn™ 7% provide the following: Dextrose Pre-Dilution Concentration Admixture Non-Protein kcal/g N Admixture Non-Protein kcal/liter Admixture g N/liter Admixture Dextrose Concentration 10% 31 170 5.5 5% Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

Revised: November, 2018 EN-4694 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

📋 Description ~1 min read ▾

DESCRIPTION 10% Dextrose Injection, USP (concentrated dextrose in water) is a sterile, nonpyrogenic, hypertonic solution of Dextrose, USP in water for injection for intravenous administration after appropriate admixture or dilution. 10% Dextrose Injection, USP is provided as a 500 mL volume in a 1000 mL partial-fill container. The container is designed to facilitate admixture or dilution.

See table under HOW SUPPLIED for summary of content and characteristics of this concentrated solution. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection following admixture or dilution. 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. Dextrose Injection, USP is a parenteral fluid and nutrient replenisher.

Dextrose Injection, 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: Water for Injection, USP is chemically designated H 2 O. structural formula dextrose

⚠️ Precautions 163 words ▾

PRECAUTIONS Electrolyte deficits, particularly in serum potassium and phosphate, may occur during prolonged use of concentrated dextrose solutions. Blood electrolyte monitoring is essential, and fluid and electrolyte imbalances should be corrected. Essential vitamins and minerals also should be provided as needed.

Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus. Care should be exercised to insure that the needle (or catheter) is well within the lumen of the vein and that extravasation does not occur. Concentrated dextrose solutions should not be administered subcutaneously or intramuscularly.

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. It is also not known whether dextrose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose should be given to a pregnant woman only if clearly needed.

This product contains no more than 25 mcg/L of aluminum.

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

PRINCIPAL DISPLAY PANEL - 500 mL Bag Label 500 mL NDC 0990-7938-19 IN 1000 mL PARTIAL-FILL CONTAINER 10% DEXTROSE Injection, USP EACH 100 mL CONTAINS DEXTROSE, HYDROUS 10 g IN WATER FOR INJECTION. 505 mOsmol/LITER (CALC.) pH 4.3 (3.2 TO 6.5) CAUTION: HYPERTONIC. ADMINISTER ONLY AFTER DILUTION.

DEXTROSE SOLUTIONS WITHOUT SALTS SHOULD NOT BE USED IN BLOOD TRANSFUSIONS BECAUSE OF POSSIBLE ROULEAU FORMATION. 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 I.V.

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 IM-4435 3 V CONTAINS DEHP icumedical ICU Medical, Inc., Lake Forest, Illinois, 60045 USA PRINCIPAL DISPLAY PANEL - 500 mL Bag Label

PRINCIPAL DISPLAY PANEL - 500 mL Bag Pouch Label TO OPEN — TEAR AT NOTCH The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap until ready for use. Visually inspect overwrap for tears or holes.

Discard unit if overwrap is damaged. Use unit promptly when pouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

See insert. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired.

Rx only WR-0559 ICU Medical, Inc., Lake Forest, Illinois, 60045 USA icumedical PRINCIPAL DISPLAY PANEL - 500 mL Bag Pouch Label

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 (this brand).

Top reported reactions

Myelosuppression1,752
Nausea1,001
Vomiting927
Acute Kidney Injury792
White Blood Cell Count Decreased719
Pyrexia700
Dyspnoea672

Age at onset

Neonate221
Infant60
Child116
Adolescent60
Adult1,763
Elderly965

Reporter sex

13,286 reports
Male · 46%
Female · 54%
Unknown · 0%

Serious outcomes

Hospitalization6,665
Death2,065
Life-threatening1,812
Disabling718
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,042 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 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.
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.
← 00990-7937-19 · ICU 00990-7941-03 · ICU →
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.