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Infant Dextrose 250 mg/mL Injection, Solution — NDC 00404-9844-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Infant Dextrose 250 mg/mL Injection, Solution — NDC 0404-9844-10 (Billing 00404-9844-10)

by Henry Schein, Inc. · 1 SYRINGE in 1 BAG / 10 mL in 1 SYRINGE

This is a package of Infant Dextrose 250 mg/mL Injection, Solution from Henry Schein, Inc., marketed since Jan 2022 and currently FDA-listed. It is this product's only package size.

NDC 00404-9844-10
🏷️ FDA NDC (as labeled) 0404-9844-10 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 (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 2, 2026 — Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. (B BRAUN MEDICAL INC) · FDA recall D-0496-2026
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) 0404-9844-10
Product NDC 0404-9844
11-digit billing NDC 00404984410
RxCUI 727518
UNII LX22YL083G
Application # NDA019445
SPL Set ID ce71d929-d11e-444c-bd45-e025d5172057
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): 727518
Why two NDCs? The FDA registers this code as 0404-9844-10 — 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 → 00404-9844-10. 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
00404-9844-10 You're viewing this Main listing 1 SYRINGE in 1 BAG / 10 mL in 1 SYRINGE 2022-01-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Infant Dextrose 250 mg/mLthis 00404-9844-10 Henry 1 syringe — — FDA listed —
Dextrose 250 mg/mL 00409-1775-10 Hospira, 1 syringe — — FDA listed —
25% Dextrose Infant 250 mg/mL 51662-1213-01 HF 1 syringe — — FDA listed —
Dextrose 250 mg/mL 70518-4452-00 REMEDYREPACK 1 syringe — — FDA listed —
Dextrose 250 mg/mL 71872-7214-01 Medical 1 syringe — — 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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. 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 🧪 Nonclinical Toxicology 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 52 words ▾

1 Indications and Usage Dextrose Injection (25%) is indicated for the treatment of acute symptomatic episodes of hypoglycemia in pediatric patients from birth up to 2 years of age. Dextrose Injection (25%) is indicated for the treatment of acute symptomatic episodes of hypoglycemia in pediatric patients younger than 2 years old. (1)

⏱️ Dosage and Administration 220 words ▾

2 Dosage and Administration

2.1Important Preparation and Administration Instructions •Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration. Do not use Dextrose Injection (25%) if the solution is cloudy or the seal has been broken. •Obtain blood glucose level prior to administering Dextrose Injection (25%). However, in cases of emergency, administer Dextrose Injection (25%) promptly without awaiting blood glucose test results. •Administer Dextrose Injection (25%) via slow intravenous injection into a central vein to reduce the risk of developing hyperglycemia and to minimize venous irritation [see Warnings and Precautions (5.1, 5.3)]. •Do not administer Dextrose Injection (25%) simultaneously with blood through the same infusion set because pseudoagglutination of red blood cells may occur. •Administer Dextrose Injection (25%) intravenously.

Do not administer Dextrose Injection (25%) subcutaneously or intramuscularly. •Discard the unused portion. •Only for intravenous infusion. Do not administer subcutaneously or intramuscularly. (2.1) •The recommended initial dose is 250 mg/kg to 500 mg/kg (1 mL/kg to 2 mL/kg).

If clinically indicated, additional single doses of 250 mg/kg to 500 mg/kg (1 mL/kg to 2 mL/kg) may be administered. (2.2) •Infusion rate depends on the age, weight, and clinical and metabolic conditions of the patient and concomitant therapy. (2.2) •See full prescribing information for more information on preparation, administration instructions, and dosing considerations.

(2.1, 2.2)

💊 Dosage Forms and Strengths 48 words ▾

3 Dosage Forms and Strengths Injection: •25% (2.5 g/10 mL) (250 mg/mL) of dextrose hydrous, in a clear, colorless solution in a single-dose Ansyr™ Plastic Syringe Injection: 25% (2.5 g/10 mL) (250 mg/mL) of dextrose hydrous in a clear, colorless solution in a single-dose Ansyr™ Plastic Syringe. (3)

⛔ Contraindications 64 words ▾

4 Contraindications Dextrose Injection (25%) is contraindicated in patients with: •Intracranial or intraspinal hemorrhage because Dextrose Injection (25%) 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. •Known hypersensitivity to dextrose [see Warnings and Precautions (5.2)]. •Intracranial or intraspinal hemorrhage. (4) •Severe dehydration. (4) •Hypersensitivity to dextrose.

(4)

⚠️ Warnings and Cautions ~2 min read ▾

5 Warnings and Precautions

5.1Hyperglycemia and Hyperosmolar Hyperglycemic State Significant hyperglycemia and hyperosmolar hyperglycemic state may result from too rapid administration of Dextrose Injection (25%). Symptoms of hyperosmolar hyperglycemic state include mental confusion and loss of consciousness. To minimize these risks, slowly inject Dextrose Injection (25%) and monitor blood glucose levels before and after treatment with Dextrose Injection (25%).

Due to the increased risk of hyperglycemia in neonates and low birth weight infants, use caution when selecting the dosage and injection rate of Dextrose Injection (25%).

5.2Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, have been reported with Dextrose Injection (25%) administration [see Adverse Reactions (6)]. Stop administration of Dextrose Injection (25%) immediately if signs or symptoms of a hypersensitivity reaction develop. Initiate appropriate treatment as clinically indicated.

5.3Phlebitis and Thrombosis Dextrose Injection (25%) 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 (25%) via slow intravenous injection into a central vein 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 (25%) and initiate corrective measures. 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 (25%) subcutaneously or intramuscularly.

5.4Electrolyte Imbalance and Fluid Overload Electrolyte deficits, particularly serum potassium and phosphate, may occur during prolonged use of Dextrose Injection (25%). Depending on the administered volume and the infusion rate, administration of Dextrose Injection (25%) can cause fluid overload, including pulmonary edema. Avoid Dextrose Injection (25%) 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 (25%) 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 younger pediatric patients, and patients treated with diuretics, and patients with cardiac or pulmonary failure or with the syndrome of inappropriate antidiuretic hormone (SIADH) (e.g., postoperative patients, patients concomitantly treated with arginine vasopressin analogs or certain antiepileptic, psychotropic, and cytotoxic drugs) [see Drug Interactions (7.1) and Use in Specific Populations (8.4)].

Avoid Dextrose Injection (25%) in patients with or at risk for hyponatremia. If use cannot be avoided, closely monitor serum sodium concentrations, chloride concentrations, fluid status, acid-base balance, and neurologic status [see Warnings and Precautions (5.4)].

5.6Neonatal Adverse Reactions from Unapproved Maternal Use at Time of Delivery Dextrose Injection (25%) is not approved for use in adolescents or adults. Maternal hyperglycemia secondary to the use of concentrated dextrose solutions at the time of delivery has been associated with adverse outcomes such as neonatal hypoglycemia. • Hyperglycemia or Hyperosmolar Hyperglycemic State : Monitor blood glucose levels before and after treatment. Use caution when selecting the dosage and injection rate due to… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 178 words ▾

6 Adverse Reactions The following clinically significant adverse reactions are also described elsewhere in the labeling: •Hyperglycemia and Hyperosmolar Hyperglycemic State [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. Revised 7/2025

🔄 Drug Interactions 126 words ▾

7 Drug Interactions

7.1Drugs with Effects on Glycemic Control and Electrolyte Balance Dextrose Injection (25%) can affect glycemic control, vasopressin, and fluid and/or electrolyte balance [see Warnings andPrecautions (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 (25%) 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 (25%) 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 143 words ▾

8 Use In Specific Populations

8.4Pediatric Use Dextrose Injection (25%) is indicated for the treatment of acute symptomatic episodes of hypoglycemia in pediatric patients from birth up to 2 years of age. Dextrose Injection (25%) 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 (25%) may also result in increased serum osmolality and increase the risk of intracerebral hemorrhage in very low birth weight neonates [see Warnings and Precautions (5.1)].

Monitor plasma electrolyte concentrations closely in pediatric patients who may have impaired ability to regulate fluids and electrolytes. Pediatric patients treated with Dextrose Injection (25%) are at increased risk of developing hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.4, 5.5)]. Dextrose Injection (25%) is not indicated in pediatric patients 2 years of age and older.

🆘 Overdosage 88 words ▾

10 Overdosage A medication error resulting in a high infusion rate of Dextrose Injection (25%) 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 (25%) 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.

📦 How Supplied / Storage and Handling 123 words ▾

16 How Supplied/Storage and Handling How Supplied Dextrose Injection, USP (25%) is supplied as a clear, colorless solution in single-dose syringe as follows: Storage and Handling Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature.] 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 0409-1775-10 Bundle of 10 Ansyr™ Plastic Syringes Single-dose containers NDC 0404-9844-10 1 10 mL Single-dose syringe in a bag (Syringe bears NDC 0409-1775-40) 2.5 g/10 mL (250 mg/mL) To contact Pfizer's Medical Information Department, please visit www.pfizermedinfo.com or call 1-800-438-1985.

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Image1.jpg

📋 Description 140 words ▾

11 Description Dextrose, USP is chemically designated D-glucose monohydrate, (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water, with 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 (25%) is a sterile, nonpyrogenic, hypertonic solution of dextrose in water for intravenous injection.

Each milliliter (mL) of fluid contains 0.25 grams of dextrose, hydrous, which delivers 3.4 kcal/gram (0.85 kcal/mL). The solution has an osmolarity of 1.39 mOsmol/mL (calculation) and the pH range is 3.2 to 6.5. May contain hydrochloric acid and sodium hydroxide for pH adjustment.

The solution contains no bacteriostatic, antimicrobial agent or added buffer (except for pH adjustment) and is supplied in a single-dose Ansyr™ Plastic Syringe. Dextrose is derived from corn. Formula1.jpg

🧪 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.

📄 Recent Major Changes 22 words ▾

Recent Major Changes Dosage and Administration (2.1, 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 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 — the ingredient across all brands.

Top reported reactions

Dyspnoea10,750
Nausea10,555
Diarrhoea9,889
Fatigue9,398
Death8,379
Pneumonia7,924
Pain7,401

Age at onset

Neonate533
Infant240
Child444
Adolescent296
Adult14,310
Elderly15,361

Reporter sex

0 reports
Male · 43%
Female · 57%
Unknown · 0%

Serious outcomes

Death27,830
Life-threatening12,832
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 14,876 6,700
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.
← 00404-9842-10 · Henry 00404-9845-50 · 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.