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Dextrose 25 g/50mL Injection, Solution — NDC 00409-7517-16 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 0409-7517-16 (Billing 00409-7517-16)

by Hospira, Inc. · 10 CARTON in 1 CONTAINER / 1 SYRINGE, PLASTIC in 1 CARTON / 50 mL in 1 SYRINGE, PLASTIC

This is a package of Dextrose 25 g/50mL Injection, Solution from Hospira, Inc., marketed since Dec 2005 and currently FDA-listed. It is this product's only package size.

NDC 00409-7517-16
🏷️ FDA NDC (as labeled) 0409-7517-16 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 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

⚠️
Active FDA shortage. Dextrose Monohydrate 50% Injection is currently reported in shortage by the FDA. Available 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) 0409-7517-16
Product NDC 0409-7517
11-digit billing NDC 00409751716
NCPDP billing unit ML — per mL (volume)
RxCUI 727517, 1795514
UNII LX22YL083G
Application # NDA019445
SPL Set ID 4ed365da-4e62-4329-c1b9-c197ab4fb6e1
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2005-12-02
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance DEXTROSE MONOHYDRATE

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

GPI-14 80100020002050
GCN Seq No 001989
GCN 06771
HICL code 000926
Ingredient (HICL) Dextrose 50 % 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 50%-WATER SYRINGE
FDB brand name Dextrose In Water
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 001989
  • GCN: 06771
  • GPI-14 (Medi-Span): 80100020002050
  • HICL (First Databank): 000926
  • AHFS class code: 40:20.00.00
  • RxCUI (RxNorm): 727517
Why two NDCs? The FDA registers this code as 0409-7517-16 — 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 → 00409-7517-16. 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 50%-WATER SYRINGE Ingredient Dextrose 50 % 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 $6.05 $3,027.05 / 500 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J7799 No ASP payment limit on file for J7799 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)0409-7517-16
11-digit billing NDC00409-7517-16
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ7799
DescriptorNOC DRUGS, OTHER THAN INHALATION DRUGS, ADMINISTERED THROUGH DME
Billing units / pkg1 units
How the units are derivedThis package is 50 ML; the HCPCS unit is 1 EA, so one package = 1 billing unit.
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
00409-7517-16 You're viewing this Main listing 10 CARTON in 1 CONTAINER / 1 SYRINGE, PLASTIC in 1 CARTON / 50 mL in 1 SYRINGE, PLASTIC 2005-12-02 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dextrose 25 g/50mL 00404-9845-50 Henry 1 syringe — — FDA listed —
Dextrose 25 g/50mLthis 00409-7517-16 Hospira, 1 syringe — — FDA listed —
50% Dextrose 25 g/50mL 51662-1216-01 HF 1 syringe — — FDA listed —
Dextrose Monohydrate 25 g/50mL 51662-1453-01 HF 1 syringe — — Discontinued —
Dextrose monohydrate 25 g/50mL 51662-1584-01 HF 1 syringe — AP FDA listed —
Dextrose 25 g/50mL 70518-4219-00 REMEDYREPACK 1 syringe — — 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 76329-3302-01 International 1 syringe — AP FDA listed —
Dextrose 25 g/50mL 84549-0517-16 ProPharma 50 ml — — FDA listed —
Dextrose 25 g/50mL 71872-7057-01 Medical 1 vial — — FDA listed —
Dextrose 25 g/50mL 00404-9847-50 Henry 1 vial — — FDA listed —
Dextrose 25 g/50mL 00409-6648-02 Hospira, 25 vials — — 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

🏛️
2005
On the market since
Dec 2005
📍
2026
Currently FDA-listed
21 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.

💡 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
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

LabelerHospira, Inc.
Application holderHOSPIRA INC
FDA applicationNDA019445 (NDA)
Labeler code00409
First marketedDec 2005
Product typeHuman Prescription Drug
Portfolio317 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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 59 words ▾

1 INDICATIONS AND USAGE Dextrose (50%) Injection is indicated for the treatment of insulin-induced hypoglycemia (e.g., hyperinsulinemia, insulin shock) in adults and pediatric patients 2 years of age and older. Dextrose Injection (50%) is indicated for the treatment of insulin-induced hypoglycemia (e.g., hyperinsulinemia, insulin shock) in adults and pediatric patients 2 years of age and older. ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION • Only for intravenous infusion. Do not administer subcutaneously or intramuscularly. ( 2.1 ) • Adults and Pediatric Patients 12 Years of Age and Older o Administer into a central vein or large peripheral vein. o Recommended dosage is 10 to 25 grams (20 to 50 mL) administered once.

Repeated doses may be administered as clinically appropriate. ( 2.2 ) • Pediatric Patients 2 to 11 Years of Age o Administer into a central vein. o Appropriate dosage depends on the age, weight, clinical and metabolic conditions of the patient, and concomitant therapy. ( 2.2 ) • Maximum rate of dextrose administration without producing hyperglycemia is 0.5 g/kg of body weight/hour.

( 2.2 ) • See full prescribing information for more information on preparation and administration instructions. ( 2.1 , 2.2 )

2.1Important Preparation and Administration Instructions • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use Dextrose Injection (50%) if the solution is cloudy or the seal has been broken. • Obtain a blood glucose level prior to administering Dextrose Injection (50%). However, in an emergency, administer Dextrose Injection (50%) promptly without awaiting blood glucose test results. • Do not administer Dextrose Injection (50%) simultaneously with blood through the same infusion set because pseudoagglutination of red blood cells may occur. • Administer Dextrose Injection (50%) intravenously.

Do not administer Dextrose Injection (50%) subcutaneously or intramuscularly. • Discard the unused portion.

2.2Recommended Dosage and Administration Adults and Pediatric Patients 12 Years of Age and Older When possible, administer Dextrose Injection (50%) into a central vein or large peripheral vein because Dextrose Injection (50%) has an osmolarity greater than 900 mOsm/L and can cause venous irritation. The recommended dosage of Dextrose Injection (50%) is 10 to 25 grams (20 to 50 mL) of Dextrose Injection (50%), administered once via intravenous infusion. Repeated doses may be administered as clinically appropriate.

Slowly infuse Dextrose Injection (50%) to reduce the risk of developing hyperglycemia and to minimize venous irritation [see Warnings and Precautions (5.1 , 5.3) ] . The maximum rate at which Dextrose Injection (50%) can be infused without producing hyperglycemia is 0.5 g/kg of body weight/hour. Pediatric Patients 2 to 11 Years of Age Administer Dextrose Injection (50%) into a central vein.

Avoid administration of Dextrose Injection (50%) into a peripheral vein because Dextrose Injection (50%) has an osmolarity greater than 900 mOsm/L and can cause venous irritation [ Warnings and Precautions (5.3) ] . If central venous access cannot be obtained, consider using an alternative commercially available dextrose product with a lower concentration. The appropriate dosage of Dextrose Injection (50%) depends on the age, weight, clinical and metabolic conditions of the patient, and concomitant therapy.

Slowly infuse Dextrose Injection (50%) to reduce the risk of developing hyperglycemia and to minimize venous irritation [see Warnings and Precautions (5.1 , 5.3 )] . The maximum rate at which Dextrose Injection (50%) can be infused without producing hyperglycemia is 0.5 g/kg of body weight/hour.

💊 Dosage Forms and Strengths 64 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 50% (25 g/50 mL) (500 mg/mL) of dextrose hydrous in a clear, colorless solution supplied as: • Single-dose Ansyr ® II Plastic Syringe with syringe and barrel detached • Single-dose Fliptop Vials Injection: 50% (25 g/50 mL) (500 mg/mL) of single-dose dextrose hydrous supplied as: • Ansyr® II Plastic Syringe with syringe and barrel detached • Fliptop Vials

⛔ Contraindications 102 words ▾

4 CONTRAINDICATIONS Dextrose Injection (50%) is contraindicated in patients with: • Intracranial or intraspinal hemorrhage because Dextrose Injection (50%) can worsen cerebral edema by causing a fluid shift across the blood-brain barrier. • Severe dehydration because of the potential to worsen the patient’s hyperosmolar state. • Alcohol withdrawal because of the potential to precipitate Wernicke encephalopathy (WE) or cardiomyopathy in thiamine-deficient patients. • Known hypersensitivity to dextrose [see Warnings and Precautions (5.2) ] . • Intracranial or intraspinal hemorrhage.

( 4 ) • Severe dehydration. ( 4 ) • Alcohol withdrawal. ( 4 ) • Known hypersensitivity to dextrose.

( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Hyperglycemia or Hyperosmolar Syndrome : Monitor blood and urine glucose; administer insulin as needed. ( 5.1 ) • Hypersensitivity Reactions : Monitor for signs and symptoms and discontinue infusion immediately if reaction occurs. ( 5.2 ) • Phlebitis and Thrombosis : Remove catheter as soon as possible if thrombophlebitis develops.

( 2.1 , 5.3 ) • Electrolyte Imbalance and Fluid Overload : Monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during administration. ( 5.4 ) • Hyponatremia : Monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and neurologic status. ( 5.5 ) • Potential Aluminum Toxicity for Patients with Immature or Impaired Renal Function : Prolonged administration of Dextrose Injection (50%) may lead to toxic levels of aluminum in pediatric patients with immature renal function or renal impairment, and in adults with renal impairment.

( 5.6 )

5.1Hyperglycemia and Hyperosmolar Hyperglycemic State Significant hyperglycemia and hyperosmolar hyperglycemic state may result from too rapid administration of Dextrose Injection (50%). Symptoms of hyperosmolar hyperglycemic state include mental confusion and loss of consciousness . To minimize these risks, slowly infuse Dextrose Injection (50%) and monitor blood and urine glucose during treatment with Dextrose Injection (50%).

If Dextrose Injection (50%) is abruptly discontinued, patients should receive 5% or 10% dextrose injection to avoid rebound hypoglycemia.

5.2Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, have been reported with Dextrose Injection (50%) administration [see Adverse Reactions (6) ] . Stop administration of Dextrose Injection (50%) immediately if signs or symptoms of a hypersensitivity reaction develop. Initiate appropriate treatment as clinically indicated.

5.3Phlebitis and Thrombosis Dextrose Injection (50%) is hypertonic (has an osmolarity greater than 900 mOsm/L) and may cause phlebitis and thrombosis at the site of injection. If thrombophlebitis occurs, remove the catheter as soon as possible. Administer Dextrose Injection (50%) via slow intravenous infusion into a central vein (when possible) to reduce the risk of phlebitis and thrombosis.

Ensure that the needle is well within the lumen of the vein and that extravasation does not occur. If thrombosis occurs, stop administration of Dextrose Injection (50%) and initiate corrective measures. Avoid administration of Dextrose Injection (50%) into a peripheral vein in pediatric patients 2 to 11 years old.

If central venous access cannot be obtained in these pediatric patients, consider using an alternative commercially available dextrose product with a lower concentration. Do not administer Dextrose Injection (50%) subcutaneously or intramuscularly.

5.4Electrolyte Imbalance and Fluid Overload Electrolyte deficits, particularly serum potassium and phosphate, may occur during prolonged use of Dextrose Injection (50%). Depending on the administered volume and the infusion rate, administration of Dextrose Injection (50%) can cause fluid overload including pulmonary edema. Avoid Dextrose Injection (50%) in patients at risk for fluid and/or solute overload.

If use cannot be avoided in these patients, monitor fluid balance, electrolyte concentrations, and acid base balance, especially during prolonged use. Additional monitoring is recommended for patients with water and electrolyte disturbances that could be aggravated by increased glucose, insulin administration, and/or free water load.

5.5Hyponatremia Dextrose Injection (50%) may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy and vomiting. The risk of hospital-acquired hyponatremia is increased in pediatric patients, geriatric patients, patients treated with diuretics, and patients with cardiac or pulmonary failure or with the syndrome of inappropr… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 187 words ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are also described elsewhere in the labeling: • Hyperglycemia and Hyperosmolar Syndrome [see Warnings and Precautions (5.1) ] • Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] • Phlebitis and Thrombosis [see Warnings and Precautions (5.3) ] • Electrolyte Imbalance and Fluid Overload [see Warnings and Precautions (5.4) ] • Hyponatremia [see Warnings and Precautions (5.5) ] The following adverse reactions associated with the use of Dextrose Injection were identified in clinical trials or postmarketing reports.

Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Administration site conditions: blister, extravasation, phlebitis, erythema, pain, vein damage, thrombosis Immune system disorders: anaphylaxis, angioedema, bronchospasm, chills, hypotension, pruritis, pyrexia, rash Cardiovascular disorders: cyanosis, volume overload The most common adverse reactions are hyperglycemia, hypersensitivity reactions, hyponatremia, infection (both systemic and at the injection site), vein thrombosis, phlebitis, and electrolyte imbalance.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 167 words ▾

7 DRUG INTERACTIONS Effects on Glycemic Control and Electrolyte Balance: Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations, and acid-base balance. Avoid use of Dextrose Injection in patients receiving drugs associated with hyponatremia. ( 7.1 )

7.1Drugs with Effects on Glycemic Control and Electrolyte Balance Dextrose Injection (50%) can affect glycemic control, vasopressin, and fluid and/or electrolyte balance [see Warnings and Precautions (5.1 , 5.4 , 5.5) ] . Monitor patients’ blood glucose concentrations, fluid balance, serum electrolyte concentrations, and acid-base balance. Concomitant administration of Dextrose Injection (50%) with drugs associated with hyponatremia may increase the risk of developing hyponatremia.

Drugs associated with hyponatremia include diuretics and those that cause SIADH (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), arginine vasopressin analogs, certain antiepileptic, psychotropic, and cytotoxic drugs). Avoid use of Dextrose Injection (50%) in patients receiving drugs associated with hyponatremia. If use cannot be avoided, closely monitor serum sodium concentrations during concomitant use [see Warnings and Precautions (5.5) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pediatric Use: Increased risk of hypoglycemia/hyperglycemia and imbalances in fluid/electrolytes; monitor serum glucose concentrations, volume status, and electrolytes. Use a different dextrose product if treatment is necessary in a pediatric patient younger than 2 years old. ( 8.4 )

8.1Pregnancy Risk Summary Appropriate administration of Dextrose Injection (50%) during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. However, maternal hyperglycemia secondary to infusion of glucose-containing products at the time of delivery has been associated with adverse neonatal outcomes such as neonatal hypoglycemia. Animal reproduction studies have not been conducted with dextrose.

The background risk of major birth defects and miscarriage in patients with insulin-induced hypoglycemia (e.g., hyperinsulinemia, insulin shock) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

8.2Lactation Risk Summary There are no data on the effects of Dextrose Injection (50%) on levels of glucose in human milk, on the breastfed infant, or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Dextrose Injection (50%) and any potential adverse effects on the breastfed infant from Dextrose Injection (50%) or from the underlying maternal condition.

8.4Pediatric Use Dextrose Injection (50%) is indicated in pediatric patients aged 2 years and older for the treatment of insulin-induced hypoglycemia (e.g., hyperinsulinemia, or insulin shock). Monitor plasma electrolyte concentrations closely in pediatric patients who may have impaired ability to regulate fluids and electrolytes [see Warnings and Precautions (5.4) ] . Pediatric patients treated with Dextrose Injection (50%) are at increased risk of developing hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.5) ] .

Dextrose Injection (50%) is not indicated for use in neonates. Dextrose Injection (50%) can increase the risk of developing hypo- or hyperglycemia in neonates, especially preterm neonates with low birth weight. Excessive or rapid administration of Dextrose Injection (50%) may also result in increased serum osmolality and risk of intracerebral hemorrhage in very low birth weight neonates.

Dextrose Injection (50%) is not indicated for use in pediatric patients younger than 2 years old due to the potential for excessive aluminum exposure. If treatment with Dextrose Injection (50%) is necessary in a pediatric patient younger than 2 years old, use a different dextrose product [see Indications and Usage (1) and Warnings and Precautions (5.6) ] .

8.5Geriatric Use Dextrose Injection (50%) has not been studied in a sufficient number of patients aged 65 and over to determine whether they respond differently from younger adult patients. Geriatric patients are at increased risk of developing hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.5) ] . Other reported clinical experience has not identified differences in responses between the geriatric and younger adult patients.

In general, the infusion rate for geriatric patients should start low and be titrated up cautiously, reflecting the greater risk for electrolyte abnormalities and fluid overload. Dextrose is known to be substantially excreted by the kidney, and the risk of adverse reactions to Dextrose Injection (50%) may be greater in patients with impaired renal function. Because geriatric patients are more likely to have impaired renal function, care should be taken in selection of the infusion rate, and patients should be closely monitored during Dextrose Injection (50%) treatment.

🤰 Pregnancy 119 words ▾

8.1Pregnancy Risk Summary Appropriate administration of Dextrose Injection (50%) during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. However, maternal hyperglycemia secondary to infusion of glucose-containing products at the time of delivery has been associated with adverse neonatal outcomes such as neonatal hypoglycemia. Animal reproduction studies have not been conducted with dextrose.

The background risk of major birth defects and miscarriage in patients with insulin-induced hypoglycemia (e.g., hyperinsulinemia, insulin shock) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

🧒 Pediatric Use 191 words ▾

8.4Pediatric Use Dextrose Injection (50%) is indicated in pediatric patients aged 2 years and older for the treatment of insulin-induced hypoglycemia (e.g., hyperinsulinemia, or insulin shock). Monitor plasma electrolyte concentrations closely in pediatric patients who may have impaired ability to regulate fluids and electrolytes [see Warnings and Precautions (5.4) ] . Pediatric patients treated with Dextrose Injection (50%) are at increased risk of developing hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.5) ] .

Dextrose Injection (50%) is not indicated for use in neonates. Dextrose Injection (50%) can increase the risk of developing hypo- or hyperglycemia in neonates, especially preterm neonates with low birth weight. Excessive or rapid administration of Dextrose Injection (50%) may also result in increased serum osmolality and risk of intracerebral hemorrhage in very low birth weight neonates.

Dextrose Injection (50%) is not indicated for use in pediatric patients younger than 2 years old due to the potential for excessive aluminum exposure. If treatment with Dextrose Injection (50%) is necessary in a pediatric patient younger than 2 years old, use a different dextrose product [see Indications and Usage (1) and Warnings and Precautions (5.6) ] .

🧓 Geriatric Use 153 words ▾

8.5Geriatric Use Dextrose Injection (50%) has not been studied in a sufficient number of patients aged 65 and over to determine whether they respond differently from younger adult patients. Geriatric patients are at increased risk of developing hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.5) ] . Other reported clinical experience has not identified differences in responses between the geriatric and younger adult patients.

In general, the infusion rate for geriatric patients should start low and be titrated up cautiously, reflecting the greater risk for electrolyte abnormalities and fluid overload. Dextrose is known to be substantially excreted by the kidney, and the risk of adverse reactions to Dextrose Injection (50%) may be greater in patients with impaired renal function. Because geriatric patients are more likely to have impaired renal function, care should be taken in selection of the infusion rate, and patients should be closely monitored during Dextrose Injection (50%) treatment.

🆘 Overdosage 94 words ▾

10 OVERDOSAGE A medication error resulting in a high infusion rate of Dextrose Injection (50%) can cause hyperglycemia, hyperosmolality, and adverse effects on fluid and electrolyte balance [see Warnings and Precautions (5.1 , 5.4) ] . Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal. In the event of overdosage (overhydration or solute overload) during Dextrose Injection (50%) treatment, discontinue the infusion.

Institute corrective measures such as administration of exogenous insulin, and treat adverse effects on the CNS, respiratory, and cardiovascular systems [see Warnings and Precautions (5.1 , 5.4) ] .

🧬 Clinical Pharmacology 52 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Dextrose restores blood glucose levels and provides a source of carbohydrate calories.

12.2Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of dextrose have not been fully characterized.

12.3Pharmacokinetics Dextrose is oxidized to carbon dioxide and water.

🧬 Mechanism of Action 16 words ▾

12.1Mechanism of Action Dextrose restores blood glucose levels and provides a source of carbohydrate calories.

📦 How Supplied / Storage and Handling 110 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Dextrose Injection, USP (50%) is supplied as a clear, colorless solution in single-dose containers as follows: Unit of Sale and Product Description Strength (Concentration) NDC Bundle of 10 50 mL Ansyr ® II Plastic Syringe with syringe and barrel detached 50% (25 g/50 mL) (0.5 g/mL) 0409-7517-16 Tray of 25 50 mL Single-Dose Fliptop Vials 50% (25 g/50 mL) (0.5 g/mL) 0409-6648-02 Storage and Handling Minimize exposure of Dextrose Injection (50%) to heat. Avoid excessive heat.

Protect from freezing. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1027-9.0 Logo

📦 Storage and Handling 41 words ▾

Storage and Handling Minimize exposure of Dextrose Injection (50%) to heat. Avoid excessive heat. Protect from freezing. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1027-9.0 Logo

📋 Description 155 words ▾

11 DESCRIPTION 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 molecular weight of dextrose (D-glucose) monohydrate is 198.17.

Dextrose Injection, USP (50%) is a sterile, nonpyrogenic, hypertonic solution of dextrose in water for injection for intravenous injection. Each milliliter (mL) of fluid contains 0.5 grams of dextrose, hydrous which delivers 3.4 kcal/gram (0.85 kcal/mL). The solution has an osmolarity of 2.53 mOsmol/mL (calculation) and the pH range is 3.2 to 6.5.

May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The Dextrose Injection (50%) vial contains no more than 600 mcg/L of aluminum. The solution contains no bacteriostatic, antimicrobial agent or added buffer (except for pH adjustment) and is supplied as single-dose containers.

Dextrose is derived from corn. Chemical Structure

🧬 Pharmacokinetics 10 words ▾

12.3Pharmacokinetics Dextrose is oxidized to carbon dioxide and water.

🧬 Pharmacodynamics 23 words ▾

12.2Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of dextrose have not been fully characterized.

🧪 Nonclinical Toxicology 28 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with dextrose to evaluate the drug’s carcinogenic potential, mutagenic potential, or effects on fertility have not been performed.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 25 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with dextrose to evaluate the drug’s carcinogenic potential, mutagenic potential, or effects on fertility have not been performed.

📄 Recent Major Changes 29 words ▾

Dosage and Administration ( 2.2 ) 07/2025 Contraindications ( 4 ) 07/2025 Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 , 5.5 , 5.6 ) 07/2025

📄 Package Label / Principal Display Panel 214 words ▾

PRINCIPAL DISPLAY PANEL - 50 mL Syringe Label - 0409-7517-66 50% DEXTROSE 50 mL Single-dose Rx only NDC 0409-7517-66 50% DEXTROSE Injection, USP 25 g/50 mL (0.5 g/mL) For intravenous use. Recommended Dosage: See Prescribing Information. Sterile, nonpyrogenic. 2.53 mOsmol/mL (calc.). pH is 3.2 to 6.5. Distributed by Hospira, Inc. Lake Forest, IL 60045 USA Hospira PAA241611 LOT AA#### EXP YYYY-MMM PRINCIPAL DISPLAY PANEL - 50 mL Syringe Label - 0409-7517-66

PRINCIPAL DISPLAY PANEL - 50 mL Syringe Carton - 0409-7517-66 50 mL NDC 0409-7517-66 50% DEXTROSE Injection, USP 25 g/50 mL (0.5 g/mL) Ansyr ® II Unit of Use Syringe For Intravenous Use Rx only LOT AA#### EXP YYYY-MMM Hospira ◀ PRESS AND PULL TO OPEN ▶ PRINCIPAL DISPLAY PANEL - 50 mL Syringe Carton - 0409-7517-66

PRINCIPAL DISPLAY PANEL - 50 mL Vial Label - 0409-6648-16 50 mL Single-dose 50% Dextrose Injection, USP 25 grams/50 mL (0.5 g/mL) Distributed by Hospira, Inc. Lake Forest, IL 60045 USA Hospira PRINCIPAL DISPLAY PANEL - 50 mL Vial Label - 0409-6648-16

PRINCIPAL DISPLAY PANEL - 50 mL Vial Tray - 0409-6648-02 50 mL Single-dose Fliptop Vial Rx only NDC 0409-6648-02 Contains 25 of NDC 0409-6648-16 50% Dextrose Injection, USP 25 grams/50 mL (0.5 g/mL) Hospira PRINCIPAL DISPLAY PANEL - 50 mL Vial Tray - 0409-6648-02

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.
📅 Q1 2025 – Q1 2026 · 5 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
1K
Units reimbursed last 4 qtrs
13.7K
Gross reimbursed last 4 qtrs
$82.9K
Avg / prescription
$80.91
Avg / unit
$6.0541
Latest quarter Q1 2026
188Rx
Fee-for-service vs managed care ⓘ
24% FFS 76% MCO
Fee-for-service · 250 Rx Managed care · 774 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: 26 units · 2.3 per 100k residents MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 3,500 units · 17.9 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 14 units · 1.5 per 100k residents SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 1,000 units · 7.7 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 24 units · 0.3 per 100k residents MA California: 520 units · 1.3 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 5,661 units · 91.4 per 100k residents MO Kentucky: 483 units · 10.7 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 14 units · 0.7 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 1,704 units · 23.9 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: 740 units · 51.6 per 100k residents HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.391.4
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 Missouri 91.4 /100k
2 Hawaii 51.6 /100k
3 Tennessee 23.9 /100k
4 New York 17.9 /100k
5 Kentucky 10.7 /100k
6 Pennsylvania 7.7 /100k
7 Montana 2.3 /100k
8 South Dakota 1.5 /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.

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 — 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 ✓ Available
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 Hospira, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Hospira, 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 J7799 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.
← 00409-7419-03 · Hospira, 00409-7535-25 · Hospira, →
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.