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Dextrose 25 g/50mL Injection, Solution — NDC 00404-9847-50 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dextrose 25 g/50mL Injection, Solution — NDC 0404-9847-50 (Billing 00404-9847-50)

by Henry Schein, Inc. · 1 VIAL, SINGLE-DOSE in 1 BAG / 50 mL in 1 VIAL, SINGLE-DOSE

This is a package of Dextrose 25 g/50mL Injection, Solution from Henry Schein, Inc., marketed since Jan 2022 and currently FDA-listed. It is this product's only package size.

NDC 00404-9847-50
🏷️ FDA NDC (as labeled) 0404-9847-50 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 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

⚠️
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) 0404-9847-50
Product NDC 0404-9847
11-digit billing NDC 00404984750
RxCUI 1795514
UNII LX22YL083G
Application # NDA019445
SPL Set ID 40fd1ac4-39bb-45fb-ba99-4fb65481f231
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-01-10
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance DEXTROSE MONOHYDRATE
Quick answers
  • RxCUI (RxNorm): 1795514
Why two NDCs? The FDA registers this code as 0404-9847-50 — 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 → 00404-9847-50. 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

📗 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 · 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
00404-9847-50 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 BAG / 50 mL in 1 VIAL, SINGLE-DOSE 2022-01-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dextrose 25 g/50mLthis 00404-9847-50 Henry 1 vial — — FDA listed —
Dextrose 25 g/50mL 00409-6648-02 Hospira, 25 vials — — FDA listed —
Dextrose 25 g/50mL 51662-1215-01 HF 50 ml — — FDA listed —
Dextrose 25 g/50mL 71872-7057-01 Medical 1 vial — — FDA listed —
Dextrose 25 g/50mL 71872-7003-01 Medical 1 syringe — — FDA listed —
Dextrose 25 g/50mL 71872-7102-01 Medical 1 syringe — — FDA listed —
Dextrose Monohydrate 25 g/50mL 71872-7282-01 Medical 1 syringe — AP FDA listed —
Dextrose Monohydrate 25 g/50mL 51662-1453-01 HF 1 syringe — — Discontinued —
Dextrose Monohydrate 25 g/50mL 76329-3302-01 International 1 syringe — AP FDA listed —
Dextrose monohydrate 25 g/50mL 51662-1584-01 HF 1 syringe — AP FDA listed —
Dextrose 25 g/50mL 00404-9845-50 Henry 1 syringe — — FDA listed —
Dextrose 25 g/50mL 00409-7517-16 Hospira, 1 syringe — — FDA listed —
Dextrose 25 g/50mL 70518-4219-00 REMEDYREPACK 1 syringe — — FDA listed —
Dextrose 25 g/50mL 84549-0517-16 ProPharma 50 ml — — 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

🏛️
2022
On the market since
Jan 2022
📍
2026
Currently FDA-listed
4 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerHenry Schein, Inc.
Application holderHOSPIRA INC
FDA applicationNDA019445 (NDA)
Labeler code00404
First marketedJan 2022
Product typeHuman Prescription Drug
Portfolio172 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 70 words ▾

Indications and Usage 50% Dextrose Injection is indicated in the treatment of insulin hypoglycemia (hyperinsulinemia or insulin shock) to restore blood glucose levels. The solution is also indicated, after dilution, for intravenous infusion as a source of carbohydrate calories in patients whose oral intake is restricted or inadequate to maintain nutritional requirements. Slow infusion of hypertonic solutions is essential to insure proper utilization of dextrose and avoid production of hyperglycemia.

⏱️ Dosage and Administration ~1 min read ▾

Dosage and Administration For peripheral vein administration: Injection of the solution should be made slowly . The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg of body weight/hour. About 95% of the dextrose is retained when infused ata rate of 0.8 g/kg/hr.

In insulin-induced hypoglycemia, intravenous injection of 10 to 25 grams of dextrose (20 to 50 mL of 50% dextrose) is usually adequate. Repeated doses and supportive treatment may be required in severe cases. A specimen for blood glucose determination should be taken before injecting the dextrose.

In such emergencies, dextrose should be administered promptly without awaiting pretreatment test results. For central venous administration: For total parenteral nutrition 50% Dextrose Injection, USP is administered by slow intravenous infusion (a) after admixture with amino acid solutions via an indwelling catheter with the tip positioned in a large central vein, preferably the superior vena cava, or (b) after dilution with sterile water for injection. Dosage should be adjusted to meet individual patient requirements.

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. The maximum rate of dextrose administration which does not result in glycosuria is the same as cited above. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

See CONTRAINDICATIONS .

⛔ Contraindications 56 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 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 146 words ▾

Warnings 50% Dextrose Injection is hypertonic and may cause phlebitis and thrombosis at the site of injection. 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. Additives may be incompatible. Consult with pharmacist if available.

When introducing additives, use aseptic technique, mix thoroughly and do not store. For peripheral vein administration: The solution 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 only after suitable dilution.

🤒 Adverse Reactions 83 words ▾

Adverse Reactions Hyperosmolar syndrome, resulting from excessively rapid administration of concentrated dextrose may cause 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.

🆘 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 123 words ▾

Clinical Pharmacolgy When administered intravenously this solution restores blood glucose levels in hypoglycemia and provides a source of carbohydrate calories. Carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein-sparing action. Dextrose injection 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 requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms.

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

📦 How Supplied / Storage and Handling 161 words ▾

How Supplied 50% Dextrose Injection, USP is supplied in single-dose containers as follows: Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Abboject® is a trademark of Abbott Labaratories. LifeShield® is the trademark of ICU Medical, Inc. and is used under license. For Medical Information about 50% Dextrose Injection, please visit www.pfizermedinfo.com or call 1-800-438-1985 Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit NDC 0409-6648-02 Tray containing 25 50 mL Single-Dose Fliptop Vials NDC 0404-9847-50 1 Single-Dose Fliptop Vial per bag (Vial bears NDC 0409-6648-16) 25 g/50 mL (0.5 g/mL) NDC 0409-7517-16 Bundle containing 10 Ansyr™ II Plastic Syringe NDC 0404-9845-50 1 Ansyr™ II Plastic Syringe per bag (Syringe bears NDC 0409-7517-66) 25 g/50 mL (0.5mg/mL) Image1.jpg

📋 Description 210 words ▾

Descprition 50% Dextrose Injection, USP is a sterile, nonpyrogenic, hypertonic solution of dextrose in water for injection for intravenous injection as a fluid and nutrient replenisher. Each mL of fluid contains 0.5 g dextrose, hydrous which delivers 3.4 kcal/gram. The solution has an osmolarity of 2.53 mOsmol/mL (calc.), pH 3.2 to 6.5 and may contain sodium hydroxide and/or hydrochloric acid for pH adjustment.

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 with the entire unit. Dextrose, USP is chemically designated C 6 H 12 O 6 ∙ H 2 O (D-glucose monohydrate), a hexose sugar freely soluble in water.

Dextrose, hydrous has the following structural formula: Water for Injection, USP is chemically designated H 2 O. The syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life.

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 syringe material. Formula1.jpg

⚠️ Precautions ~1 min read ▾

Precautions Do not use unless the solution is clear and seal is intact. Discard unused portion. 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. To minimize hyperglycemia and consequent glycosuria, it is desirable to monitor blood and urine glucose and if necessary, add insulin.

When a concentrated dextrose infusion is abruptly withdrawn, it is advisable to follow with the administration of 5% or 10% dextrose injection to avoid rebound hypoglycemia. 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 is well within the lumen of the vein and that extravasation does not occur.

If thrombosis should occur during administration, the injection should be stopped and corrective measures instituted. Concentrated dextrose solutions should not be administered subcutaneously or intramuscularly. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with solutions in polypropylene syringes have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Pregnancy : 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.

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 50% Dextrose Injection, USP is administered to a nursing mother.

📄 Package Label / Principal Display Panel 4 words ▾

Sample Package Label Label1.jpg

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Dextrose (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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 Henry Schein, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Henry Schein, 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.
← 00404-9845-50 · Henry 00404-9848-10 · Henry →
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.