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Ferumoxytol 510 mg/17mL Injection — NDC 0781-3154-95 (Billing 00781-3154-95)

by Sandoz Inc · 10 VIAL, SINGLE-DOSE in 1 CARTON / 17 mL in 1 VIAL, SINGLE-DOSE

This is a package of Ferumoxytol 510 mg/17mL Injection from Sandoz Inc, marketed since Jul 2021 and currently FDA-listed.

NDC 00781-3154-95
🏷️ FDA NDC (as labeled) 0781-3154-95 billing pads the labeler segment with a zero
This package
Contains17 mL in 1 vial, single-dose Pack sizes2 compare ↓
Product page 00781-3154-01 Also comes in: 17 mL 0781-3154-01
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0781-3154-95 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0781 labeler · 3154 product · 95 package
Package marketed since
Jul 15, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0781315495 2
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0781-3154-95
Product NDC 0781-3154
11-digit billing NDC 00781315495
RxCUI 860605
UNII CLH5FT6412
Application # ANDA206604
SPL Set ID cf94c7fc-13a0-4ac9-bb85-9c38aa704d35
Established class (EPC) Parenteral Iron Replacement
Chemical class Iron
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-07-15
Route INTRAVENOUS
Dosage form INJECTION
Substance FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 065348
GCN 26275
HICL code 036439
Ingredient (HICL) Ferumoxytol
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C3
Therapeutic class — intermediate (HIC2) Minerals
HIC3 code C3B
Therapeutic class — specific (HIC3) Iron Replacement
AHFS code 20:04.04.00
AHFS class Iron Preparations
FDB label name FERUMOXYTOL 510 MG/17 ML VIAL
FDB brand name Ferumoxytol
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 065348
  • GCN: 26275
  • HICL (First Databank): 036439
  • AHFS class code: 20:04.04.00
  • RxCUI (RxNorm): 860605
Why two NDCs? The FDA registers this code as 0781-3154-95 — 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 → 00781-3154-95. 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 Parenteral Iron Replacement class.

Pharmacologic class Parenteral Iron Replacement
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 FERUMOXYTOL 510 MG/17 ML VIAL Ingredient Ferumoxytol
📖 What it is MedlinePlus · NLM

Ferumoxytol injection is used to treat iron-deficiency anemia (a lower than normal number of red blood cells due to too little iron) in adults with chronic kidney disease (damage to the kidneys which may worsen over time and may cause the kidneys to stop working). Ferumoxytol injection is used to treat iron-deficiency anemia in people who did not respond or are unable to tolerate taking iron preparations by mouth. Ferumoxytol injection is in a class of medications called iron replacement products. It works by replenishing iron stores so that the body can make more red blood cells.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Ferumoxytol treats iron deficiency anemia in adults who cannot tolerate oral iron or did not respond to it, and in adults with chronic kidney disease. The FeraBright product is dif...
  • It is given through a vein as an infusion that lasts at least 15 minutes. You will be watched for at least 30 minutes afterward. Staff will check your blood pressure and pulse.
  • Some people get diarrhea, headache, nausea, dizziness, constipation, or swelling in the legs or hands. Low blood pressure can also happen. Most of these are manageable.
  • Severe allergic reactions are the main concern. Tell staff right away if you have trouble breathing, wheezing, hives, swelling, chest pain, or feel faint. These reactions usually h...
📖 Read our full Ferumoxytol Injection 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 eachPer 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.
Try another pack size: 17 mL
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
00781-3154-01 0781-3154-01 Main listing 1 VIAL, SINGLE-DOSE in 1 CARTON / 17 mL in 1 VIAL, SINGLE-DOSE 2021-07-15 — Active
00781-3154-95 You're viewing this 10 VIAL, SINGLE-DOSE in 1 CARTON / 17 mL in 1 VIAL, SINGLE-DOSE 2021-07-15 — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 10 vial, single-dose in 1 carton / 17 ml in 1 vial, single-dose.
What NDC number is used to bill for this package of Ferumoxytol 510 mg/17mL Injection?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ferumoxytol 510 mg/17mLthis 00781-3154-95 Sandoz 10 vials — AB FDA listed —
Feraheme 510 mg/17mL 59338-0775-01 AMAG 1 vial — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2021
On the market since
Jul 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

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

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 748 mg / 17 mL UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.

1 inactive ingredient listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerSandoz Inc
Application holderSANDOZ INC
FDA applicationANDA206604 (ANDA)
Labeler code00781
First marketedJul 2021
Product typeHuman Prescription Drug
Portfolio391 products on file

More NDCs from Sandoz Inc labeler code 00781

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.
🚨 Boxed Warning 🎯 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 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving ferumoxytol. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest. • Only administer ferumoxytol as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions [see Warnings and Precautions ( 5.1 ) ]. • Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following ferumoxytol infusion including monitoring of blood pressure and pulse during and after ferumoxytol administration [see Warnings and Precautions ( 5.1 ) ]. • Hypersensitivity reactions have occurred in patients in whom a previous ferumoxytol dose was tolerated [see Warnings and Precautions ( 5.1 ) ] .

WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS See full prescribing information for complete boxed warning. Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving ferumoxytol. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest. • Only administer ferumoxytol as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.

( 5.1 ) • Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following ferumoxytol infusion including monitoring of blood pressure and pulse during and after ferumoxytol administration. ( 5.1 ) • Hypersensitivity reactions have occurred in patients in whom a previous ferumoxytol dose was tolerated. ( 5.1 )

🎯 Indications and Usage 88 words ▾

1 INDICATIONS AND USAGE Ferumoxytol is indicated for the treatment of iron deficiency anemia (IDA) in adult patients: • who have intolerance to oral iron or have had unsatisfactory response to oral iron or • who have chronic kidney disease (CKD). Ferumoxytol is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in adult patients: • who have intolerance to oral iron or have had unsatisfactory response to oral iron ( 1 ) or • who have chronic kidney disease (CKD). ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended dose of ferumoxytol injection is an initial 510 mg dose followed by a second 510 mg dose 3 to 8 days later. Administer ferumoxytol as an intravenous infusion in 50 to 200 mL 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP over at least 15 minutes. Take measures to avoid extravasation, as this can lead to skin discoloration or staining, which may be long lasting.

If extravasation occurs, discontinue Ferumoxytol administration at that site. Administer while the patient is in a reclined or semi-reclined position. Ferumoxytol injection does not contain antimicrobial preservatives.

Discard unused portion. Ferumoxytol injection, when added to intravenous infusion bags containing either 0.9% Sodium Chloride Injection, USP (normal saline), or 5% Dextrose Injection, USP, at concentrations of 2 to 8 mg elemental iron per mL, should be used immediately but may be stored at controlled room temperature (25°C ± 2°C) for up to 4 hours or refrigerated (2 to 8° C) for up to 48 hours The dosage is expressed in terms of mg of elemental iron, with each mL of ferumoxytol containing 30 mg of elemental iron. Evaluate the hematologic response (hemoglobin, ferritin, iron and transferrin saturation) at least one month following the second ferumoxytol infusion.

The recommended ferumoxytol injection dose may be readministered to patients with persistent or recurrent iron deficiency anemia. For patients receiving hemodialysis, administer ferumoxytol once the blood pressure is stable and the patient has completed at least one hour of hemodialysis. Monitor for signs and symptoms of hypotension following each ferumoxytol infusion.

Allow at least 30 minutes between administration of ferumoxytol and administration of other medications that could potentially cause serious hypersensitivity reactions and/or hypotension, such as chemotherapeutic agents or monoclonal antibodies. Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. • The recommended dose of ferumoxytol is an initial 510 mg dose followed by a second 510 mg dose 3 to 8 days later. ( 2 ) • Administer ferumoxytol as an intravenous infusion in 50 to 200 mL 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP over at least 15 minutes.

( 2 )

💊 Dosage Forms and Strengths 44 words ▾

3 DOSAGE FORMS AND STRENGTHS Ferumoxytol Injection is available in single-dose vials. Each vial contains 510 mg of elemental iron in 17 mL (30 mg per mL). Injection: 510 mg iron per 17 mL (30 mg per mL) in single-dose vials. ( 3 )

⛔ Contraindications 73 words ▾

4 CONTRAINDICATIONS Ferumoxytol injection is contraindicated in patients with: • Known hypersensitivity to ferumoxytol injection or any of its components [see Warnings and Precautions ( 5.1 )] . • History of allergic reaction to any intravenous iron product [see Warnings and Precautions ( 5.1 )] . • Known hypersensitivity to ferumoxytol injection or any of its components. ( 4 ) • History of allergic reaction to any intravenous iron product. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Greater risk of anaphylaxis in patients with multiple drug allergies. (5.1) • Hypotension: Ferumoxytol may cause hypotension. Monitor for signs and symptoms of hypotension following each administration of ferumoxytol.

(5.2) • Iron Overload: Regularly monitor hematologic responses during ferumoxytol therapy. Do not administer ferumoxytol to patients with iron overload. (5.3) • Magnetic Resonance Imaging Test Interference: Ferumoxytol can alter magnetic resonance imaging (MRI) studies.

(5.4)

5.1Serious Hypersensitivity Reactions Fatal and serious hypersensitivity reactions including anaphylaxis, presenting with cardiac/ cardiorespiratory arrest, clinically significant hypotension, syncope, or unresponsiveness have occurred in patients receiving ferumoxytol. Other adverse reactions potentially associated with hypersensitivity have occurred (pruritus, rash, urticaria, and wheezing). These reactions have occurred following the first dose or subsequent doses in patients in whom a previous ferumoxytol dose was tolerated.

Patients with a history of multiple drug allergies may have a greater risk of anaphylaxis with parenteral iron products. Carefully consider the potential risks and benefits before administering ferumoxytol to these patients. Only administer ferumoxytol as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.

Closely observe patients for signs and symptoms of hypersensitivity including monitoring of blood pressure and pulse during and after ferumoxytol administration for at least 30 minutes and until clinically stable following completion of each infusion [see Adverse Reactions ( 6.2 ) ]. In a clinical study in patients with IDA, regardless of etiology, hypersensitivity reactions were reported in 0.4% (4/997) of subjects receiving ferumoxytol administered as intravenous infusion over at least 15 minutes. These included one patient with severe hypersensitivity reaction and three patients with moderate hypersensitivity reactions.

In clinical studies predominantly in patients with IDA and CKD, serious hypersensitivity reactions were reported in 0.2% (4/1,806) of subjects receiving ferumoxytol (administered as a rapid intravenous injection – prior method of administration no longer approved). Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.5% (63/1,806) of these subjects. In the post-marketing experience, fatal and serious anaphylactic type reactions presenting with cardiac/ cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported.

Elderly patients with multiple or serious co-morbidities who experience hypersensitivity reactions and/or hypotension following administration of ferumoxytol may have more severe outcomes [s ee Boxed Warning , Adverse Reactions ( 6.2 ) and Use in Specific Populations ( 8.5 )].

5.2Hypotension Ferumoxytol may cause clinically significant hypotension. In a clinical study with ferumoxytol in patients with IDA, regardless of etiology, moderate hypotension was reported in 0.2% (2/997) of subjects receiving ferumoxytol administered as intravenous infusion over at least 15 minutes. In clinical studies in patients with IDA and CKD, hypotension was reported in 1.9% (35/1,806) of subjects, including three patients with serious hypotensive reactions, who had received ferumoxytol as a rapid intravenous injection (prior method of administration no longer approved).

Hypotension has also been reported in the post-marketing experience [see Adverse Reactions ( 6.2 )]. Monitor patients for signs and symptoms of hypotension following each ferumoxytol administration [see Dosage and Administration ( 2 ) and Warnings and Precautions ( 5.1 )].

5.3Iron Overload Excessive therapy with parenteral iron can lead to excess stor… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Serious Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] • Hypotension [see Warnings and Precautions ( 5.2 )] • Iron Overload [see Warnings and Precautions ( 5.3 )] • Magnetic Resonance (MR) Imaging Test Interference [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (≥ 2%) are diarrhea, headache, nausea, dizziness, hypotension, constipation, and peripheral edema.

(6.1) To report SUSPECTED ADVERSE REACTIONS with ferumoxytol injection, contact Sandoz Inc., at 1-800-525-8747, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical studies, 3,968 subjects were exposed to ferumoxytol. Of these subjects 31% were male and the median age was 54 years (range of 18 to 96 years).

The data described below reflect exposure to ferumoxytol in 997 patients exposed to a 1.02 g course of ferumoxytol administered as two 510 mg intravenous (IV) doses: 992 subjects (99.5%) received at least 1 complete dose of ferumoxytol and 946 subjects (94.9%) received 2 complete doses. The mean cumulative IV Iron exposure was 993.80 ±119.085 mg. The safety of ferumoxytol was studied in a randomized, multicenter, double-blind clinical trial in patients with IDA (IDA Trial 3), [see Clinical Studies (14.1)].

In this trial, patients were randomized to two intravenous infusions of 510 mg (1.02 g) of ferumoxytol (n=997), or two intravenous infusions of 750 mg (1.500 g) of ferric carboxymaltose (FCM) (n=1000). Both intravenous irons were infused over a period of at least 15 minutes. Most patients received their second infusion of ferumoxytol and FCM 7(+1) days after Dose 1.

The mean (SD) age of the study population (N=1997) was 55.2 (17.16) years. The majority of patients were female (76.1%), white (71.4%) and non-Hispanic (81.8%). The mean (SD) hemoglobin at baseline for all patients was 10.4 (1.5) g/dl.

Serious adverse events were reported in 3.6% (71/1997) of ferumoxytol-and FCM-treated patients. The most common (≥2 subjects) serious AEs reported in ferumoxytol-treated patients were syncope, gastroenteritis, seizure, pneumonia, hemorrhagic anemia, and acute kidney injury. In FCM-treated patients the most common (≥2 subjects) serious AEs were syncope, cardiac failure congestive, angina pectoris, and atrial fibrillation.

Adverse reactions related to ferumoxytol and reported by ≥ 1% of ferumoxytol-treated patients in IDA Trial 3 are listed in Table 1 . Table 1: Adverse Reactions to Ferumoxytol Reported in ≥1% of IDA Patients in IDA Trial 3 Adverse Reactions Ferumoxytol 2 x 510 mg (N = 997) % Ferric Carboxymaltose 2 x 750 mg (N = 1000) % Headache 3.4

3.1Nausea 1.8

3.4Dizziness 1.5

1.6Fatigue 1.5

1.2 Diarrhea 1

0.8 Back Pain 1

0.4In IDA Trial 3, adverse reactions leading to treatment discontinuation and occurring in ≥ 2 ferumoxytol-treated patients included arthralgia (0.3%), dyspnea (0.3%), flushing (0.2%), chest discomfort (0.2%), chest pain (0.2%), nausea (0.2%), back pain (0.2%), dizziness (0.2%) and headache (0.2%). Across two clinical trials in patients with IDA (IDA Trial 1 and 2), [see Clinical Studies ( 14.1 )], patients were randomized to: two injections (rapid intravenous injection -prior method of administration no longer approved) of 510 mg of ferumoxytol (n=1,014), placebo (n=200), or five injections/infusions of 200 mg of iron sucrose (n=199).

Most patients received their second ferumoxytol injection 3 to 8 days after the first injection. Adverse reactions related to ferumoxytol and reported by ≥ 1% of ferumoxytol-treated patients in these trials were similar to those seen in Trial 3. In Trials 1 and 2… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 22 words ▾

7 DRUG INTERACTIONS Drug-drug interaction studies with ferumoxytol were not conducted. Ferumoxytol may reduce the absorption of concomitantly administered oral iron preparations.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Limited available data with ferumoxytol use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. There are risks to the mother and fetus associated with untreated iron deficiency anemia (IDA) in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions ( see Clinical Considerations ). In animal studies, administration of ferumoxytol to pregnant rabbits during organogenesis caused adverse developmental outcomes including fetal malformations and decreased fetal weights at maternally toxic doses of 6 times the estimated human daily dose.

The estimated background risk of major birth defects and miscarriage for the indicated populations 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 defect and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Fetal/Neonatal adverse reactions Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as ferumoxytol) which may cause fetal bradycardia, especially during the second and third trimester.

Data Animal Data Administration of ferumoxytol during organogenesis, at doses of 31.6 mg Fe/kg/day in rats and 16.5 mg Fe/kg/day in rabbits, did not result in maternal or fetal effects. These doses are approximately 2 times the estimated human daily dose based on body surface area. In rats, administration of ferumoxytol during organogenesis at a maternally toxic dose of 100 mg Fe/kg/day, approximately 6 times the estimated human daily dose based on body surface area, caused a decrease in fetal weights.

In rabbits, administration of ferumoxytol during organogenesis at a maternally toxic dose of 45 mg Fe/kg/day, approximately 6 times the estimated human daily dose based on body surface area, was associated with external and soft tissue fetal malformations and decreased fetal weights.

8.2Lactation Risk Summary There are no data on the presence of ferumoxytol in human milk, the effects on the breastfed child, or the effects on milk production. Ferumoxytol has been detected in the milk of lactating rats. However, due to species-specific differences in lactation physiology, the clinical relevance of these data are not clear.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ferumoxytol and any potential adverse effects on the breastfed child from ferumoxytol or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of ferumoxytol in pediatric patients (less than 18 years old) have not been established.

8.5Geriatric Use In controlled clinical trials, 833 patients ≥ 65 years of age were treated with ferumoxytol. No overall differences in safety and efficacy were observed between older and younger patients in these trials, but greater sensitivity of older individuals cannot be ruled out. In general, dose administration to an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Elderly patients with multiple or serious co-morbidities who experience hypersensitivity reactions and/or hypotension following administration of ferumoxytol may have more severe outcomes. The potential risks and benefits of ferumoxytol administration should be carefully… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Limited available data with ferumoxytol use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. There are risks to the mother and fetus associated with untreated iron deficiency anemia (IDA) in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions ( see Clinical Considerations ). In animal studies, administration of ferumoxytol to pregnant rabbits during organogenesis caused adverse developmental outcomes including fetal malformations and decreased fetal weights at maternally toxic doses of 6 times the estimated human daily dose.

The estimated background risk of major birth defects and miscarriage for the indicated populations 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 defect and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Fetal/Neonatal adverse reactions Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as ferumoxytol) which may cause fetal bradycardia, especially during the second and third trimester.

Data Animal Data Administration of ferumoxytol during organogenesis, at doses of 31.6 mg Fe/kg/day in rats and 16.5 mg Fe/kg/day in rabbits, did not result in maternal or fetal effects. These doses are approximately 2 times the estimated human daily dose based on body surface area. In rats, administration of ferumoxytol during organogenesis at a maternally toxic dose of 100 mg Fe/kg/day, approximately 6 times the estimated human daily dose based on body surface area, caused a decrease in fetal weights.

In rabbits, administration of ferumoxytol during organogenesis at a maternally toxic dose of 45 mg Fe/kg/day, approximately 6 times the estimated human daily dose based on body surface area, was associated with external and soft tissue fetal malformations and decreased fetal weights.

🧒 Pediatric Use 21 words ▾

8.4Pediatric Use The safety and effectiveness of ferumoxytol in pediatric patients (less than 18 years old) have not been established.

🧓 Geriatric Use 131 words ▾

8.5Geriatric Use In controlled clinical trials, 833 patients ≥ 65 years of age were treated with ferumoxytol. No overall differences in safety and efficacy were observed between older and younger patients in these trials, but greater sensitivity of older individuals cannot be ruled out. In general, dose administration to an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Elderly patients with multiple or serious co-morbidities who experience hypersensitivity reactions and/or hypotension following administration of ferumoxytol may have more severe outcomes. The potential risks and benefits of ferumoxytol administration should be carefully considered in these patients [see Dosage and Administration ( 2 ), Warnings and Precautions ( 5.1 ), and Clinical Studies ( 14 )].

🆘 Overdosage 66 words ▾

10 OVERDOSAGE Limited data are available regarding overdosage of ferumoxytol in humans. Excessive dosages of ferumoxytol may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. Do not administer ferumoxytol to patients with iron overload [Warnings and Precautions ( 5.3 )].

Ferumoxytol is not removed by hemodialysis. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Ferumoxytol consists of a superparamagnetic iron oxide that is coated with a carbohydrate shell, which helps to isolate the bioactive iron from plasma components until the iron-carbohydrate complex enters the reticuloendothelial system macrophages of the liver, spleen and bone marrow. The iron is released from the iron-carbohydrate complex within vesicles in the macrophages. Iron then either enters the intracellular storage iron pool (e.g., ferritin) or is transferred to plasma transferrin for transport to erythroid precursor cells for incorporation into hemoglobin.

12.2Pharmacodynamics Cardiac Electrophysiology In a randomized, positive- and placebo-controlled, parallel-group study, healthy subjects received a supratherapeutic regimen of ferumoxytol (1.02 g given as two 510 mg doses within 24 hours), placebo or a single dose of 400 mg moxifloxacin (positive control). Results demonstrated no effect of ferumoxytol on QT interval durations. No clinically meaningful effect of ferumoxytol on heart rate was observed.

12.3Pharmacokinetics The pharmacokinetic (PK) behavior of ferumoxytol has been examined in healthy subjects and in patients with CKD stage 5D on hemodialysis. Ferumoxytol exhibited dose-dependent, capacity-limited elimination from plasma with a half-life of approximately 15 hours in humans. The clearance (CL) was decreased by increasing the dose of ferumoxytol.

Volume of distribution (Vd) was consistent with plasma volume, and the mean maximum observed plasma concentration (C max ) and terminal half-life (t 1/2 ) values increased with dose. The estimated values of CL and Vd following two 510 mg doses of ferumoxytol administered intravenously within 24 hours were 69.1 mL/hr and

3.16L, respectively. The C max and time of maximum concentration (t max ) were 206 mcg/mL and 0.32 hr, respectively. Rate of infusion had no influence on ferumoxytol PK parameters. No gender differences in ferumoxytol PK parameters were observed. Ferumoxytol is not removed by hemodialysis.

🧬 Mechanism of Action 84 words ▾

12.1Mechanism of Action Ferumoxytol consists of a superparamagnetic iron oxide that is coated with a carbohydrate shell, which helps to isolate the bioactive iron from plasma components until the iron-carbohydrate complex enters the reticuloendothelial system macrophages of the liver, spleen and bone marrow. The iron is released from the iron-carbohydrate complex within vesicles in the macrophages. Iron then either enters the intracellular storage iron pool (e.g., ferritin) or is transferred to plasma transferrin for transport to erythroid precursor cells for incorporation into hemoglobin.

📦 Storage and Handling 86 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Ferumoxytol injection is available in single-dose vials in the following package sizes ( Table 6 ). Table 6: Ferumoxytol Packaging Description NDC Code Dose/Total volume per vial Vials/Carton NDC 0781-3154-01 510 mg/17 mL 1 NDC 0781-3154-95 510 mg/17 mL 10

16.2Stability and Storage Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in the original package to protect from light. Protect from freezing.

📋 Description 147 words ▾

11 DESCRIPTION Ferumoxytol is an iron replacement product containing ferumoxytol for intravenous infusion. Ferumoxytol is a non-stoichiometric magnetite (superparamagnetic iron oxide) coated with polyglucose sorbitol carboxymethylether. The overall colloidal particle size is 17 to 31 nm in diameter.

The chemical formula of ferumoxytol is Fe 5874 O 8752 -C 11719 H 18682 O 9933 Na 414 with an apparent molecular weight of 750 kDa. Ferumoxytol injection is a sterile aqueous colloidal product that is formulated with mannitol. It is a reddish brown liquid, and is provided in single-dose vials containing 510 mg of elemental iron.

Each mL of the sterile colloidal solution of ferumoxytol injection contains 30 mg of elemental iron and 44 mg of mannitol, and 30 mg polyglucose sorbitol carboxymethylether. The formulation is isotonic with an osmolality of 270 to 330 mOsm/kg. The product contains no preservatives, and has a pH of 6 to 8.

💬 Information for Patients 89 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information) Prior History of Allergies to Parenteral Iron Products Question patients regarding any prior history of allergies to parenteral iron products [see Warnings and Precautions ( 5.1 )]. Hypersensitivity Reactions Advise patients to immediately report any symptoms of hypersensitivity that may develop during and following ferumoxytol administration, such as rash, itching, dizziness, light-headedness, swelling, and breathing problems [see Warnings and Precautions ( 5.1 )].

Manufactured by Lek d.d., Slovenia for Sandoz Inc., Plainsboro, NJ 08536

🧬 Pharmacokinetics 148 words ▾

12.3Pharmacokinetics The pharmacokinetic (PK) behavior of ferumoxytol has been examined in healthy subjects and in patients with CKD stage 5D on hemodialysis. Ferumoxytol exhibited dose-dependent, capacity-limited elimination from plasma with a half-life of approximately 15 hours in humans. The clearance (CL) was decreased by increasing the dose of ferumoxytol.

Volume of distribution (Vd) was consistent with plasma volume, and the mean maximum observed plasma concentration (C max ) and terminal half-life (t 1/2 ) values increased with dose. The estimated values of CL and Vd following two 510 mg doses of ferumoxytol administered intravenously within 24 hours were 69.1 mL/hr and

3.16L, respectively. The C max and time of maximum concentration (t max ) were 206 mcg/mL and 0.32 hr, respectively. Rate of infusion had no influence on ferumoxytol PK parameters. No gender differences in ferumoxytol PK parameters were observed. Ferumoxytol is not removed by hemodialysis.

🧬 Pharmacodynamics 63 words ▾

12.2Pharmacodynamics Cardiac Electrophysiology In a randomized, positive- and placebo-controlled, parallel-group study, healthy subjects received a supratherapeutic regimen of ferumoxytol (1.02 g given as two 510 mg doses within 24 hours), placebo or a single dose of 400 mg moxifloxacin (positive control). Results demonstrated no effect of ferumoxytol on QT interval durations. No clinically meaningful effect of ferumoxytol on heart rate was observed.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Iron Deficiency Anemia in Patients Who Are Intolerant to Oral Iron or Have Had Unsatisfactory Response to Oral Iron IDA-301 Trial (referred to as IDA Trial 1) (NCT 01114139), IDA-302 Trial (referred to as IDA Trial 2) (NCT 01114204) and IDA-304 Trial (referred to as IDA Trial 3) (NCT 02694978). The safety and efficacy of ferumoxytol in patients with iron deficiency anemia, regardless of etiology and a history of unsatisfactory oral iron therapy or in whom oral iron could not be used, were assessed in two randomized, controlled clinical trials (IDA Trial 1 and 2) with ferumoxytol administered as a rapid intravenous injection (prior method of administration no longer approved).

In IDA Trial 1, patients were randomized to treatment with ferumoxytol or placebo. In IDA Trial 2, patients were randomized to treatment with ferumoxytol or iron sucrose. Ferumoxytol (510 mg) and placebo were administered as two intravenous single dose injections over 3-8 days, and iron sucrose (200 mg) was administered as 5 intravenous injections or infusions over a period of 14 days.

In IDA Trial 1, the mean age of patients was 45 years (range, 18 to 91); 89% were female; 56% were Caucasian, 25% were Black, 16% were Asian, and 3% were other races. In IDA Trial 2, the mean age of patients was 48 years (range, 18 to 89); 83% were female; 84% were Caucasian, 11% were Asian, 1% were Black, and 4% were other races. Table 3 shows changes from baseline to Week 5 in hemoglobin and transferrin saturation in IDA Trial 1 and 2.

Table 3: Changes from Baseline to Week 5 in Hemoglobin (Hgb) and Transferrin Saturation in IDA Trial 1 and 2 (Intent to Treat Population) ENDPOINT IDA Trial 1 IDA Trial 2 Ferumoxytol N = 608 Placebo N = 200 Ferumoxytol N = 406 Iron Sucrose N = 199 Baseline Hgb mean (SD), g/dL 8.9 (0.9) 8.8 (0.9) 8.9 (0.9) 8.8 (1.0) Proportion of patients with Hgb Increase of ≥2 g/dL at any time from Baseline to Week 5, % 81.1 5.5 84

81.4Treatment Difference (%, 95% CI) 75.6 p≤0.001 for main efficacy endpoint (71.2, 80) 2.6 (-3.9, 9.1) Mean change in Hgb from Baseline to Week 5 mean (SD), g/dL 2.6 (1.5) 0.1 (0.9) 2.9 (1.6) 2.7 (1.3) Proportion of patients with Hgb ≥12 g/dL at any time from Baseline to Week 5, % 50.5 3 66.7

48.2Baseline TSAT mean (SD) , % 7 (12.9) 5.4 (4.9) 6.1 (9.9) 5.5 (10.3) Mean change in TSAT from Baseline to Week 5 mean (SD), % 11.4 (15.1) 0.4 (5.8) 15.7 (16.8) 9.2 (14.4) In IDA Trial 1, fatigue-related symptoms and impacts were assessed using a patient reported outcome instrument, FACIT-Fatigue (score range from 0 to 52 with higher scores indicating less fatigue). After 5 weeks, ferumoxytol-treated patients reported greater improvement from baseline in the fatigue score (+11.7 ± 11.73 points) than did patients in the placebo arm (+6.8 ± 9.51 points) with a treatment difference of 4.9 (95% CI: 3.08-6.71) points.

The safety of ferumoxytol in IDA patients with a history of unsatisfactory oral iron therapy or in whom oral iron could not be used was also assessed in another randomized, multicenter, double-blind safety clinical trial (IDA Trial 3). Patients were randomized in a 1:1 ratio to either two infusions of 510 mg (1.020 g) of ferumoxytol (n=997) or two infusions of 750 mg (1.500 g) of ferric carboxymaltose (FCM) (n=1000). Both IV irons were infused over a period of at least 15 minutes.

Most patients received their second infusion of ferumoxytol or FCM 7(+1) days after the first infusion. This study included patients with any etiology of IDA including CKD excluding dialysis-dependent CKD. In IDA Trial 3, the mean age of patients was 55 years (range, 18 to 96); 76% were female; 71% were Caucasian, 24% were Black, 3% were Asian, and 2% were other races.

The study met the primary endpoint to demonstrate non-inferiority to FCM with respect to the percentage of patients who experienced moderate-to-severe hypersensitivity reactions (including anaphylaxis) or moderate-to-severe hypotension (ferumoxytol: 0.6%; FCM:… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 210 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Ferumoxytol was not tested for carcinogenic effects. In standard genotoxicity tests, ferumoxytol showed no evidence of mutagenic activity in an in vitro Ames test or clastogenic activity in either an in vitro chromosomal aberration assay or an in vivo micronucleus assay. No adverse effects on fertility or general reproductive performance were noted in animal studies.

Ferumoxytol had no effect on male or female fertility or general reproductive function in rats. In a pre and postnatal development study in rats, intravenous administration of ferumoxytol from gestation day 6 until lactation day 20 at doses up to 60 mg/kg/day (approximately 3 times the daily human dose based on body surface area comparisons assuming a 60-kg person) had no effect on maternal delivery or numbers of liveborn offspring. Male offspring (F1) of pregnant rats (F0) administered ferumoxytol at a dose of 60 mg/kg/day had delayed sexual maturation and decreased reproductive competence.

Female offspring (F1) of pregnant rats (F0) administered ferumoxytol at doses of 30 mg/kg/day or 60 mg/kg/day had delayed sexual maturation and decreased reproductive competence. Doses of 30 mg/kg/day and 60 mg/kg/day are approximately 2 and 3 times the daily human dose based on body surface area comparisons assuming a 60-kg person, respectively.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 207 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Ferumoxytol was not tested for carcinogenic effects. In standard genotoxicity tests, ferumoxytol showed no evidence of mutagenic activity in an in vitro Ames test or clastogenic activity in either an in vitro chromosomal aberration assay or an in vivo micronucleus assay. No adverse effects on fertility or general reproductive performance were noted in animal studies.

Ferumoxytol had no effect on male or female fertility or general reproductive function in rats. In a pre and postnatal development study in rats, intravenous administration of ferumoxytol from gestation day 6 until lactation day 20 at doses up to 60 mg/kg/day (approximately 3 times the daily human dose based on body surface area comparisons assuming a 60-kg person) had no effect on maternal delivery or numbers of liveborn offspring. Male offspring (F1) of pregnant rats (F0) administered ferumoxytol at a dose of 60 mg/kg/day had delayed sexual maturation and decreased reproductive competence.

Female offspring (F1) of pregnant rats (F0) administered ferumoxytol at doses of 30 mg/kg/day or 60 mg/kg/day had delayed sexual maturation and decreased reproductive competence. Doses of 30 mg/kg/day and 60 mg/kg/day are approximately 2 and 3 times the daily human dose based on body surface area comparisons assuming a 60-kg person, respectively.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Ferumoxytol Injection (FER-ue-MOX-i-tol), for intravenous use What is the most important information I should know about ferumoxytol injection? Ferumoxytol injection may cause serious side effects, including: • Serious allergic reactions that may lead to death. Serious allergic reactions have happened in people after receiving the first dose of ferumoxytol injection or after receiving additional doses in people who did not previously have an allergic reaction.

If you have a history of allergies to many different medicines, you may have an increased risk of serious allergic reactions to ferumoxytol injection. Tell your healthcare provider or get medical help right away if you get any of these signs or symptoms: ∘ rash ∘ itching ∘ dizziness or lightheadedness ∘ swelling of the tongue or throat ∘ wheezing or trouble breathing See “What are the possible side effects of ferumoxytol injection?” for more information about side effects. What is ferumoxytol injection?

Ferumoxytol injection is a prescription medicine used to treat iron deficiency anemia in adults who have: • intolerance to oral iron or who have not responded well to treatment with oral iron or • chronic kidney disease (CKD) It is not known if ferumoxytol injection is safe and effective in children less than 18 years of age. Who should not receive ferumoxytol injection? Do not receive ferumoxytol injection if you: • are allergic to ferumoxytol injection or any of the ingredients in ferumoxytol injection .

See the end of this leaflet for a complete list of ingredients in ferumoxytol injection . • have had an allergic reaction to any iron medicine given into your vein by intravenous (IV) infusion. Before receiving ferumoxytol injection, tell your healthcare provider about all of your medical conditions, including if you: • have allergies to many different medicines. • have low blood pressure (hypotension). • have iron overload. • are pregnant or plan to become pregnant. It is not known if ferumoxytol injection will harm your unborn baby. • are breastfeeding or plan to breastfeed.

It is not known if ferumoxytol passes into your breast milk. You and your healthcare provider should decide if you will receive ferumoxytol injection or breastfeed. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive ferumoxytol injection? • Ferumoxytol injection will be given to you into your vein by intravenous (IV) infusion over at least 15 minutes by your healthcare provider. You will receive ferumoxytol injection in 2 doses 3 to 8 days apart. • Your healthcare provider will watch you during and for at least 30 minutes after you receive ferumoxytol injection. • Ferumoxytol can cause discoloration or staining of your skin if leaking happens at your infusion site. Tell your healthcare provider if you notice any leaking from the infusion site during your infusion.

What are the possible side effects of ferumoxytol injection? Ferumoxytol injection may cause serious side effects, including: • See “What is the most important information I should know about ferumoxytol injection?” • Low blood pressure (hypotension) . Your healthcare provider will check you for signs and symptoms of hypotension after each ferumoxytol infusion. • Iron overload .

Your healthcare provider will do blood tests to check your iron levels during treatment with ferumoxytol injection. • Magnetic resonance imaging (MRI) test interference . Ferumoxytol may alter the test results of MRIs. You should have any planned MRI test before starting treatment with Ferumoxytol.

Ferumoxytol may alter MRI test results during and for up to 3 months after your last dose of Ferumoxytol. The most common side effects of ferumoxytol injection include: • diarrhea • headache • nausea • dizziness • low blood pressure • constipation • swelling of your legs, feet, arms, or hands These are not all of the possible sid… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 30 words ▾

PRINCIPAL DISPLAY PANEL NDC 0781-3154-01 Rx only Ferumoxytol Injection 510 mg elemental iron Per 17 mL (30 mg/mL) For Intravenous Use only Single-Dose Vial - Discard Unused Portion SANDOZ label

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 vial00781-3154-01 9,578 Rx · $4,489,244
10 vials this page00781-3154-95 No Medicaid data
Drug total (last 4 qtrs): 9,578 Rx · 190,214 units · $4,489,244 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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 Ferumoxytol — the ingredient across all brands.

Top reported reactions

Dyspnoea462
Nausea238
Flushing228
Back Pain210
Hypotension205
Infusion Related Reaction203
Anaphylactic Reaction183

Reporter sex

1,902 reports

Serious outcomes

Life-threatening165
Death131
Disabling18
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 246 32
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — 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 Sandoz Inc. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 vial (00781-3154-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Sandoz 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.
← 00781-3153-95 · Sandoz 00781-3156-95 · Sandoz →
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.