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Ferric Carboxymaltose 50 mg/mL Injection, Solution — NDC 00781-3542-94 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ferric Carboxymaltose 50 mg/mL Injection, Solution — NDC 0781-3542-94 (Billing 00781-3542-94)

by Sandoz, Inc. · 1 VIAL, SINGLE-DOSE in 1 BOX / 15 mL in 1 VIAL, SINGLE-DOSE

This is a package of Ferric Carboxymaltose 50 mg/mL Injection, Solution from Sandoz, Inc., marketed since Jul 2026 and currently FDA-listed. It is this product's only package size.

NDC 00781-3542-94
🏷️ FDA NDC (as labeled) 0781-3542-94 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 Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 0781-3542-94 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0781 labeler · 3542 product · 94 package
Package marketed since
Jul 3, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0781354294 0
FDA record last changed
Sep 17, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0781-3542-94
Product NDC 0781-3542
11-digit billing NDC 00781354294
NCPDP billing unit ML — per mL (volume)
RxCUI 1435169
UNII 6897GXD6OE
Application # NDA203565
SPL Set ID bfdf7447-62e4-48ca-b903-11cb3b211064
Established class (EPC) Parenteral Iron Replacement; Phosphate Binder
Mechanism of action Phosphate Chelating Activity
Chemical class Iron
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-07-03
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance FERRIC CARBOXYMALTOSE
TE code (Orange Book) AP · RLD · RS
Quick answers
  • RxCUI (RxNorm): 1435169
Why two NDCs? The FDA registers this code as 0781-3542-94 — 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 → 00781-3542-94. 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.

Clinical

📖 What it is MedlinePlus · NLM

Ferric carboxymaltose injection is used to treat iron deficiency anemia (a lower than normal number of red blood cells) . Ferric carboxymaltose injection is in a class of medications called iron replacement products. It works by providing iron to help the body make more red blood cells.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It replaces iron through a vein. It treats iron deficiency anemia if oral iron didn't work or caused problems, and anemia in adults with non-dialysis chronic kidney disease. It als...
  • A healthcare professional gives it into a vein, either as a slow push or a drip. Many people get two doses at least a week apart, and your prescriber sets your schedule.
  • Nausea, flushing, dizziness, higher blood pressure and reactions at the IV site are the most common. Tell your nurse about any discomfort at the IV site right away.
  • Allergic reactions can be serious, so you'll be watched for at least 30 minutes. Call for help for trouble breathing, hives, wheezing or faintness. Later, report tiredness, muscle...
📖 Read our full Ferric Carboxymaltose 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 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
00781-3542-94 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 BOX / 15 mL in 1 VIAL, SINGLE-DOSE 2026-07-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Injectafer 50 mg/mL 00517-0602-01 American 1 vial — AP FDA listed —
Injectafer 50 mg/mL 00517-0650-01 American 1 vial — AP FDA listed —
Ferric Carboxymaltose 50 mg/mLthis 00781-3542-94 Sandoz, 1 vial — AP FDA listed —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. 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
First FDA approval
Apr 2021
📍
2026
Currently FDA-listed
5 years listed
🛡️
2028
Latest patent/protection listed
not a guaranteed launch date
🔒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.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Feb 2028. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 28, 2021 AP TE-rated RLD RS ⏳ ~1.4 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8895612 — method of use (U-1620)
US 7754702 — method of use (U-1432)
US 11478502 — method of use (U-3472)
US 11478502 — method of use (U-3472)
US 11478502 — method of use (U-3472)
US 11478502 — method of use (U-3472)
US 11478502 — method of use (U-3473)
US 11478502 — method of use (U-3473)
US 11478502 — method of use (U-3473)
US 11478502 — method of use (U-3473)
US 11478502 — method of use (U-3474)
US 11478502 — method of use (U-3474)
US 11478502 — method of use (U-3474)
US 11478502 — method of use (U-3474)
US 11433091 — method of use (U-3435)
US 11433091 — method of use (U-3435)
US 11433091 — method of use (U-3435)
US 11433091 — method of use (U-3435)
US 11433091 — method of use (U-3436)
US 11433091 — method of use (U-3436)
US 11433091 — method of use (U-3436)
US 11433091 — method of use (U-3436)
US 11433091 — method of use (U-3437)
US 11433091 — method of use (U-3437)
US 11433091 — method of use (U-3437)
US 11433091 — method of use (U-3437)
US 11433091 — method of use (U-3438)
US 11433091 — method of use (U-3438)
US 11433091 — method of use (U-3438)
US 11433091 — method of use (U-3438)
US 11364260 — method of use (U-3637)
US 11364260 — method of use (U-3637)
US 11364260 — method of use (U-3637)
US 11364260 — method of use (U-3637)
US 8895612 — method of use (U-3051)
US 8895612 — method of use (U-1620)
US 8895612 — method of use (U-3050)
US 7754702 — method of use (U-2556)
US 7754702 — method of use (U-2557)
US 7754702 — method of use (U-2555)
US 8895612 — method of use (U-3115)
US 8895612 — method of use (U-3116)
US 8895612 — method of use (U-3116)
US 8895612 — method of use (U-3115)
US 8895612 — method of use (U-3115)
US 8895612 — method of use (U-3050)
US 8895612 — method of use (U-3116)
US 8895612 — method of use (U-1620)
US 8895612 — method of use (U-3051)
US 7754702 — method of use (U-2555)
US 7754702 — method of use (U-2557)
US 7754702 — method of use (U-2556)
US 11433091 — method of use (U-3634)
US 11433091 — method of use (U-3634)
US 11433091 — method of use (U-3634)
US 11433091 — method of use (U-3634)
US 8895612 — method of use (U-3635)
US 8895612 — method of use (U-3635)
US 8895612 — method of use (U-3635)
US 8895612 — method of use (U-3635)
US 7754702 — method of use (U-3636)
US 7754702 — method of use (U-3636)
US 7754702 — method of use (U-3636)
US 7754702 — method of use (U-3636)
US 7754702 — method of use (U-3312)
US 7754702 — method of use (U-3314)
US 7754702 — method of use (U-3313)
US 8895612 — method of use (U-3315)
US 8895612 — method of use (U-3316)
US 8895612 — method of use (U-3116)
US 8895612 — method of use (U-3115)
US 8895612 — method of use (U-3315)
US 8895612 — method of use (U-3316)
US 8895612 — method of use (U-3316)
US 8895612 — method of use (U-3315)
US 8895612 — method of use (U-3316)
US 8895612 — method of use (U-3315)
US 7754702 — method of use (U-3314)
US 7754702 — method of use (U-3312)
US 7754702 — method of use (U-3313)
US 7754702 — method of use (U-3314)
US 7754702 — method of use (U-3313)
US 7754702 — method of use (U-3312)
US 7754702 — method of use (U-3313)
US 7754702 — method of use (U-3314)
US 7754702 — method of use (U-3312)
US 7612109 — drug substance
US 7612109 — drug substance
US 7612109 — drug substance
US 7612109 — drug substance
Exclusivity I-915
Exclusivity I-915
Exclusivity I-915
Exclusivity I-915
2021 2023 2025 2027
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (90)
PatentTypeUse codeExpires
US 8895612 ↗ Method of use U-1620 Jan 8, 2027
US 7754702 ↗ Method of use U-1432 Feb 15, 2028
US 11478502 ↗ Method of use U-3472 Jan 8, 2027
US 11478502 ↗ Method of use U-3472 Jan 8, 2027
US 11478502 ↗ Method of use U-3472 Jan 8, 2027
US 11478502 ↗ Method of use U-3472 Jan 8, 2027
US 11478502 ↗ Method of use U-3473 Jan 8, 2027
US 11478502 ↗ Method of use U-3473 Jan 8, 2027
US 11478502 ↗ Method of use U-3473 Jan 8, 2027
US 11478502 ↗ Method of use U-3473 Jan 8, 2027
US 11478502 ↗ Method of use U-3474 Jan 8, 2027
US 11478502 ↗ Method of use U-3474 Jan 8, 2027
US 11478502 ↗ Method of use U-3474 Jan 8, 2027
US 11478502 ↗ Method of use U-3474 Jan 8, 2027
US 11433091 ↗ Method of use U-3435 Jan 8, 2027
US 11433091 ↗ Method of use U-3435 Jan 8, 2027
US 11433091 ↗ Method of use U-3435 Jan 8, 2027
US 11433091 ↗ Method of use U-3435 Jan 8, 2027
US 11433091 ↗ Method of use U-3436 Jan 8, 2027
US 11433091 ↗ Method of use U-3436 Jan 8, 2027
US 11433091 ↗ Method of use U-3436 Jan 8, 2027
US 11433091 ↗ Method of use U-3436 Jan 8, 2027
US 11433091 ↗ Method of use U-3437 Jan 8, 2027
US 11433091 ↗ Method of use U-3437 Jan 8, 2027
US 11433091 ↗ Method of use U-3437 Jan 8, 2027
US 11433091 ↗ Method of use U-3437 Jan 8, 2027
US 11433091 ↗ Method of use U-3438 Jan 8, 2027
US 11433091 ↗ Method of use U-3438 Jan 8, 2027
US 11433091 ↗ Method of use U-3438 Jan 8, 2027
US 11433091 ↗ Method of use U-3438 Jan 8, 2027
US 11364260 ↗ Method of use U-3637 Jan 8, 2027
US 11364260 ↗ Method of use U-3637 Jan 8, 2027
US 11364260 ↗ Method of use U-3637 Jan 8, 2027
US 11364260 ↗ Method of use U-3637 Jan 8, 2027
US 8895612 ↗ Method of use U-3051 Jan 8, 2027
US 8895612 ↗ Method of use U-1620 Jan 8, 2027
US 8895612 ↗ Method of use U-3050 Jan 8, 2027
US 7754702 ↗ Method of use U-2556 Feb 15, 2028
US 7754702 ↗ Method of use U-2557 Feb 15, 2028
US 7754702 ↗ Method of use U-2555 Feb 15, 2028
US 8895612 ↗ Method of use U-3115 Jan 8, 2027
US 8895612 ↗ Method of use U-3116 Jan 8, 2027
US 8895612 ↗ Method of use U-3116 Jan 8, 2027
US 8895612 ↗ Method of use U-3115 Jan 8, 2027
US 8895612 ↗ Method of use U-3115 Jan 8, 2027
US 8895612 ↗ Method of use U-3050 Jan 8, 2027
US 8895612 ↗ Method of use U-3116 Jan 8, 2027
US 8895612 ↗ Method of use U-1620 Jan 8, 2027
US 8895612 ↗ Method of use U-3051 Jan 8, 2027
US 7754702 ↗ Method of use U-2555 Feb 15, 2028
US 7754702 ↗ Method of use U-2557 Feb 15, 2028
US 7754702 ↗ Method of use U-2556 Feb 15, 2028
US 11433091 ↗ Method of use U-3634 Jan 8, 2027
US 11433091 ↗ Method of use U-3634 Jan 8, 2027
US 11433091 ↗ Method of use U-3634 Jan 8, 2027
US 11433091 ↗ Method of use U-3634 Jan 8, 2027
US 8895612 ↗ Method of use U-3635 Jan 8, 2027
US 8895612 ↗ Method of use U-3635 Jan 8, 2027
US 8895612 ↗ Method of use U-3635 Jan 8, 2027
US 8895612 ↗ Method of use U-3635 Jan 8, 2027
US 7754702 ↗ Method of use U-3636 Feb 15, 2028
US 7754702 ↗ Method of use U-3636 Feb 15, 2028
US 7754702 ↗ Method of use U-3636 Feb 15, 2028
US 7754702 ↗ Method of use U-3636 Feb 15, 2028
US 7754702 ↗ Method of use U-3312 Feb 15, 2028
US 7754702 ↗ Method of use U-3314 Feb 15, 2028
US 7754702 ↗ Method of use U-3313 Feb 15, 2028
US 8895612 ↗ Method of use U-3315 Jan 8, 2027
US 8895612 ↗ Method of use U-3316 Jan 8, 2027
US 8895612 ↗ Method of use U-3116 Jan 8, 2027
US 8895612 ↗ Method of use U-3115 Jan 8, 2027
US 8895612 ↗ Method of use U-3315 Jan 8, 2027
US 8895612 ↗ Method of use U-3316 Jan 8, 2027
US 8895612 ↗ Method of use U-3316 Jan 8, 2027
US 8895612 ↗ Method of use U-3315 Jan 8, 2027
US 8895612 ↗ Method of use U-3316 Jan 8, 2027
US 8895612 ↗ Method of use U-3315 Jan 8, 2027
US 7754702 ↗ Method of use U-3314 Feb 15, 2028
US 7754702 ↗ Method of use U-3312 Feb 15, 2028
US 7754702 ↗ Method of use U-3313 Feb 15, 2028
US 7754702 ↗ Method of use U-3314 Feb 15, 2028
US 7754702 ↗ Method of use U-3313 Feb 15, 2028
US 7754702 ↗ Method of use U-3312 Feb 15, 2028
US 7754702 ↗ Method of use U-3313 Feb 15, 2028
US 7754702 ↗ Method of use U-3314 Feb 15, 2028
US 7754702 ↗ Method of use U-3312 Feb 15, 2028
US 7612109 ↗ Drug substance — Feb 5, 2027
US 7612109 ↗ Drug substance — Feb 5, 2027
US 7612109 ↗ Drug substance — Feb 5, 2027
US 7612109 ↗ Drug substance — Feb 5, 2027
FDA exclusivity
CodeWhat it grantsExpires
I-915New indication (3-year)May 31, 2026
I-915New indication (3-year)May 31, 2026
I-915New indication (3-year)May 31, 2026
I-915New indication (3-year)May 31, 2026
Common questions
Is there a generic version of this drug?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for this drug. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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

LabelerSandoz, Inc.
Application holderAMERICAN REGENT INC
FDA applicationNDA203565 (NDA AUTHORIZED GENERIC)
Labeler code00781
First marketedJul 2026
Product typeHuman Prescription Drug
Portfolio3 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 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: SYMPTOMATIC HYPOPHOSPHATEMIA • FERRIC CARBOXYMALTOSE INJECTION can cause severe, prolonged hypophosphatemia associated with serious outcomes, including hospitalization, osteomalacia and fractures requiring clinical intervention [see Warnings and Precautions ( 5 . 1 )]. • Hypophosphatemia has occurred in patients with normal baseline phosphate levels and without apparent risk factors for hypophosphatemia [see Warnings and Precautions ( 5.1 )]. • Check serum phosphate levels prior to a repeat course of treatment in patients at risk for low serum phosphate and in any patient who receives a repeat course of therapy within three months [see Dosage and Administration ( 2.1 , 2.3) ] .

Correct pre-existing hypophosphatemia prior to administering FERRIC CARBOXYMALTOSE INJECTION [see Warnings and Precautions ( 5.1 )] . • Advise patients receiving FERRIC CARBOXYMALTOSE INJECTION about the risk of hypophosphatemia and to report any signs and symptoms of hypophosphatemia (e.g., fatigue, muscle weakness or pain, bone and joint pain, bone fractures) [see Warnings & Precautions ( 5. 1 )] . WARNING: SYMPTOMATIC HYPOPHOSPHATEMIA See full prescribing information for complete boxed warning. • FERRIC CARBOXYMALTOSE INJECTION can cause severe, prolonged hypophosphatemia associated with serious outcomes, including hospitalization, osteomalacia and fractures requiring clinical intervention ( 5.1 ). • Hypophosphatemia has occurred in patients with normal baseline phosphate levels and without apparent risk factors for hypophosphatemia ( 5.1 ). • Check serum phosphate levels prior to a repeat course of treatment in patients at risk for low serum phosphate and in any patient who receives a repeat course of therapy within three months.

Correct pre-existing hypophosphatemia prior to administering FERRIC CARBOXYMALTOSE INJECTION ( 2.1 , 2.3 , 5.1 ) . • Advise patients receiving FERRIC CARBOXYMALTOSE INJECTION about the risk of hypophosphatemia and to report any signs and symptoms of hypophosphatemia (e.g., fatigue, muscle weakness or pain, bone and joint pain, bone fractures) ( 5.1) .

🎯 Indications and Usage 147 words ▾

1 INDICATIONS AND USAGE Ferric carboxymaltose injection is indicated for the treatment of: • Iron deficiency anemia (IDA) in: adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. adult patients who have non-dialysis dependent chronic kidney disease. • Iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity. Ferric carboxymaltose injection is an iron replacement product indicated for the treatment of: • iron deficiency anemia (IDA) in: adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron.

( 1 ) adult patients who have non-dialysis dependent chronic kidney disease. ( 1 ) • iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For patients weighing 50 kg or more, the recommended dosage is ferric carboxymaltose injection 750 mg intravenously in two doses separated by at least 7 days for a total cumulative dose of 1,500 mg of iron per course. For adult patients weighing 50 kg or more, an alternative dose of ferric carboxymaltose injection 15 mg/kg body weight up to a maximum of 1,000 mg intravenously may be administered as a single-dose per course. ( 2.

2) For patients weighing less than 50 kg, the recommended dosage is ferric carboxymaltose injection 15 mg/kg body weight intravenously in two doses separated by at least 7 days per course. ( 2.2 ) See Section 2.2, Table 1 for dosage in patients with iron deficiency and heart failure. ( 2.

2) Ferric carboxymaltose injection treatment may be repeated if IDA or iron deficiency in heart failure reoccurs. ( 2.3 )

2.1Laboratory Testing Check serum phosphate levels prior to a repeat course of treatment in patients at risk for low serum phosphate and in any patient who receives a repeat course of therapy within three months [see Boxed Warning and Dosage and Administration ( 2.3 ) ]. Correct pre-existing hypophosphatemia prior to administering ferric carboxymaltose injection [see Warnings and Precautions ( 5.1 )].

2.2Recommended Dosage Recommended Dosage for Treatment of Iron Deficiency Anemia For patients weighing 50 kg or more, the recommended dosage is: Ferric carboxymaltose injection 750 mg intravenously in two doses separated by at least 7 days for a total cumulative dose of 1,500 mg of iron per course. In adult patients, ferric carboxymaltose injection 15 mg/kg body weight up to a maximum of 1,000 mg intravenously may be administered as a single-dose per course. For patients weighing less than 50 kg, the recommended dosage is ferric carboxymaltose injection 15 mg/kg body weight intravenously in two doses separated by at least 7 days per course.

Recommended Dosage in Patients with Iron Deficiency with Heart Failure See Table 1 for recommended dosage for treatment of iron deficiency in patients with heart failure and New York Heart Association class II/III to improve exercise capacity. Table 1: Recommended Dosage in Patients with Iron Deficiency with Heart Failure Weight less than 70 kg Weight 70 kg or more Hb (g/dL) Hb (g/dL) < 10 10 to 14 > 14 to < 15 < 10 10 to 14 > 14 to < 15 Day 1 1,000 mg 1,000 mg 500 mg 1,000 mg 1,000 mg 500 mg Week 6 500 mg No dose No dose 1,000 mg 500 mg No dose Administer a maintenance dose of 500 mg at 12, 24 and 36 weeks if serum ferritin <100 ng/mL or serum ferritin 100-300 ng/mL with transferrin saturation <20%.

There are no data available to guide dosing beyond 36 weeks or with Hb ≥15 g/dL.

2.3Repeat Dosage Courses Ferric carboxymaltose injection treatment may be repeated if IDA or iron deficiency in heart failure reoccurs.

2.4Preparation and Administration Administer ferric carboxymaltose injection intravenously, either as an undiluted slow intravenous push or by infusion. When administered via infusion, dilute up to 1,000 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL and administer over at least 15 minutes. When added to an infusion bag containing 0.9% sodium chloride injection, USP, at concentrations ranging from 2 to 4 mg of iron per mL, ferric carboxymaltose injection solution is physically and chemically stable for 72 hours when stored at room temperature.

To maintain stability, do not dilute to concentrations less than 2 mg iron/mL. Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives.

Each vial of ferric carboxymaltose injection is intended for a single dose. When administering ferric carboxymaltose injection 500 or 750 mg as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. For fe… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 29 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 50 mg/mL, dark brown, non-transparent, sterile, aqueous solution. 750 mg iron/15 mL single-dose vial Injection: 50 mg/mL 750 mg iron/15 mL single-dose vial

⛔ Contraindications 41 words ▾

4 CONTRAINDICATIONS Ferric carboxymaltose injection is contraindicated in patients with a history of hypersensitivity to ferric carboxymaltose injection or any of its components [see Warnings and Precautions ( 5.2) ]. Hypersensitivity to ferric carboxymaltose injection or any of its inactive components.

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after ferric carboxymaltose injection administration for at least 30 minutes and until clinically stable following completion of each administration. ( 5. 2) Hypertension: Monitor patients closely for signs and symptoms of hypertension following each ferric carboxymaltose injection administration. ( 5.3 )

5.1Symptomatic Hypophosphatemia Symptomatic hypophosphatemia, including severe cases, with serious outcomes such as osteomalacia and fractures requiring clinical intervention have occurred in patients treated with ferric carboxymaltose injection in the post-marketing setting. These cases have occurred after single and multiple doses of ferric carboxymaltose injection. Risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat-soluble vitamins or phosphate, inflammatory bowel disease, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency, malnutrition, and hereditary hemorrhagic telangiectasia (HHT or Osler-Weber-Rendu syndrome).

However, individuals without apparent risk factors have experienced symptomatic hypophosphatemia. In most cases, hypophosphatemia resolved within three months. Check serum phosphate levels prior to a repeat course of treatment if the patient is at risk for low serum phosphate or if the patient will receive a repeat course of therapy within three months of the prior course [see Dosage and Administration ( 2.1 , 2.3 )] .

Correct pre-existing hypophosphatemia prior to administering ferric carboxymaltose injection. Monitor serum phosphate levels in patients at risk for chronic low serum phosphate. Treat hypophosphatemia as medically indicated.

Consider permanent discontinuation of ferric carboxymaltose injection for severe symptomatic hypophosphatemia or persistent hypophosphatemia.

5.2Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving ferric carboxymaltose injection . Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after ferric carboxymaltose injection administration for at least 30 minutes and until clinically stable following completion of the infusion.

Only administer ferric carboxymaltose injection when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions [see Adverse Reactions ( 6.1 , 6 .2 )]. In clinical trials, serious anaphylactic/anaphylactoid reactions were reported in 0.1% (2/1,775) of subjects receiving ferric carboxymaltose injection . Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but not limited to, pruritus, rash, urticaria, wheezing, or hypotension were reported in 1.5% (26/1,775) of these subjects.

5.3Hypertension In clinical studies, hypertension was reported in 4% (67/1,775) of subjects in clinical trials 1 and 2. Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed in 6% (106/1,775) of subjects in these two clinical trials. These elevations generally occurred immediately after dosing and resolved within 30 minutes.

Monitor patients for signs and symptoms of hypertension following each ferric carboxymaltose injection administration [see Dosage and Administration ( 2 )].

5.4Laboratory Test Alterations In the 24 hours following administration of ferric carboxymaltose injection, laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in ferric carboxymaltose injection.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Symptomatic Hypophosphatemia [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] Hypertension [see Warnings and Precautions ( 5.3 )] Laboratory Test Alterations [see Warnings and Precautions ( 5.4 )] The most common adverse reactions in adult patients (>2%) are nausea, hypertension, flushing, injection site reactions, erythema, hypophosphatemia, and dizziness.

( 6.1 ) The most common adverse reactions in pediatric patients (≥4%) are hypophosphatemia, injection site reactions, rash, headache, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact American Regent at 1-800-734-9236 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, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice. Adults In two randomized clinical studies [Studies 1 and 2, see Clinical Studies ( 14 )] , a total of 1,775 patients were exposed to ferric carboxymaltose injection 15 mg/kg body weight up to a maximum single dose of 750 mg of iron on two occasions separated by at least 7 days up to a cumulative dose of 1,500 mg of iron.

Adverse reactions reported by ≥1% of treated patients are shown in the following table. Table 2. Adverse reactions reported in ≥1% of Study Patients in Clinical Trials 1 and 2 Ferric Carboxymaltose Injection (N=1,775) % Pooled Comparators a (N=1,783) % Oral iron (N=253) % Nausea 7.2 2

1.2 Hypertension* 4 2

0.4Flushing* 4 0.2 0 Injection site reactions* 3 3.2 0 Erythema* 3 0.6 0 Hypophosphatemia 2.1 0.1 0 Dizziness* 2.1 1.3

0.4 Vomiting 2 1

0.4Injection Site Discoloration** 1.4 0.3 0 Headache* 1.3 1.2

0.4Hepatic enzyme increased* 1.2 0.2 0 Dysgeusia* 1.2 2.1 0 Hypotension 1 2 0 Rash* 1 0.3 0 Constipation 0.5 0.9 3.2 a Includes oral iron and all formulations of IV iron other than ferric carboxymaltose injection *Grouped Terms: Hypertension includes hypertension, blood pressure increased, and hypertensive crisis. Flushing includes flushing and hot flush. Injection site reactions include injection site extravasation, injection site discoloration, injection site pain, injection site irritation, injection site bruising, injection site reaction, injection site discomfort, injection site erythema, injection site hematoma, injection site hemorrhage, injection site pruritus, injection site rash, and injection site swelling.

Erythema includes erythema and injection site erythema. Dizziness includes dizziness, balance disorder, and vertigo. **Injection site discoloration was also included in the injection site local administration reactions grouped term. Headache includes headache and migraine.

Hepatic enzyme increased includes alanine aminotransferase increased and aspartate aminotransferase increased. Dysgeusia includes dysgeusia and ageusia. Rash includes rash, urticaria, skin exfoliation, blister, erythema multiforme, injection site rash, rash maculo-papular, and rash pruritic.

Other adverse reactions reported by ≥0.5% of treated patients include abdominal pain, diarrhea, gamma glutamyl transferase increased, paresthesia, and sneezing. Transient decreases in laboratory blood phosphorus levels (<2 mg/dL) have been observed in 27% (440/1,638) of patients in clinical trials. Pooled data from two Phase 3 studies 1VIT09030 (NCT00981045) and 1VIT09031 (NCT00982007) with a dosing regimen of ferric carboxymaltose injection 15 mg/kg up to a maximum of 750 mg x 2 doses to a cumulative dose of 1,500 mg of iron were analyzed to compare rates of adverse reactions in two Phase 3 parallel group studies 1VIT07017 (NCT00548860) and 1VIT07018 (NCT00548691) with a dosing regimen of ferric carboxymaltose injection 15 mg/kg up to a maximum of 1,000 mg… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Risk of hypersensitivity reactions which may have serious consequences for the fetus. ( 8.1 )

8.1Pregnancy Risk Summary Parenteral iron administration may be associated with hypersensitivity reactions [ see Warnings and Precautions ( 5.2 )], which may have serious consequences, such as fetal bradycardia ( see Clinical Considerations ). Advise pregnant women of the potential risk to a fetus. Published studies and available data from postmarketing reports with intravenous ferric carboxymaltose injection are insufficient to assess the risk of major birth defects and miscarriage.

There are risks to the mother and fetus associated with untreated IDA in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions (see Clinical Considerations). In animal reproduction studies, administration of ferric carboxymaltose to rabbits during the period of organogenesis caused adverse developmental outcomes including fetal malformations and increased implantation loss at maternally toxic doses of approximately 12% to 23% of the human weekly dose of 750 mg (based on body surface area).

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 defects 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 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 ferric carboxymaltose injection ) which may cause fetal bradycardia, especially during the second and third trimester.

Data Human Data Published data from randomized controlled studies, prospective observational studies and retrospective studies on the use of ferric carboxymaltose in pregnant women have not reported an association with intravenous ferric carboxymaltose and major birth defects and miscarriage. However, these studies cannot establish or exclude the absence of any drug-related risk during pregnancy. Animal Data Administration of ferric carboxymaltose to rats as a one-hour intravenous infusion up to 30 mg/kg/day iron on gestation days 6 to 17 did not result in adverse embryonic or fetal findings.

This daily dose in rats is approximately 40% of the human weekly dose of 750 mg based on body surface area. In rabbits, ferric carboxymaltose was administered as a one-hour infusion on gestation days 6 to 19 at iron doses of 4.5, 9, 13.5, and 18 mg/kg/day. Malformations were seen starting at the daily dose of 9 mg/kg (23% of the human weekly dose of 750 mg).

Spontaneous abortions occurred starting at the daily iron dose of 4.5 mg/kg (12% of the human weekly dose of 750 mg based on body surface area). Pre-implantation loss was at the highest dose. Adverse embryonic or fetal effects were observed in the presence of maternal toxicity.

A pre- and post-natal development study was conducted in rats at intravenous doses up to 18 mg/kg/day of iron (approximately 23% of the weekly human dose of 750 mg based on body surface area). There were no adverse effects on survival of offspring, their behavior, sexual maturation or reproductive parameters.

8.2Lactation Risk Summary The available published data on the use of ferric carboxymaltose in lactating women demonstrate that iron is present in breast milk. Among the breastfed infants, adverse reactions included constipation and diarrhea but none of the adve… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Parenteral iron administration may be associated with hypersensitivity reactions [ see Warnings and Precautions ( 5.2 )], which may have serious consequences, such as fetal bradycardia ( see Clinical Considerations ). Advise pregnant women of the potential risk to a fetus. Published studies and available data from postmarketing reports with intravenous ferric carboxymaltose injection are insufficient to assess the risk of major birth defects and miscarriage.

There are risks to the mother and fetus associated with untreated IDA in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions (see Clinical Considerations). In animal reproduction studies, administration of ferric carboxymaltose to rabbits during the period of organogenesis caused adverse developmental outcomes including fetal malformations and increased implantation loss at maternally toxic doses of approximately 12% to 23% of the human weekly dose of 750 mg (based on body surface area).

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 defects 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 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 ferric carboxymaltose injection ) which may cause fetal bradycardia, especially during the second and third trimester.

Data Human Data Published data from randomized controlled studies, prospective observational studies and retrospective studies on the use of ferric carboxymaltose in pregnant women have not reported an association with intravenous ferric carboxymaltose and major birth defects and miscarriage. However, these studies cannot establish or exclude the absence of any drug-related risk during pregnancy. Animal Data Administration of ferric carboxymaltose to rats as a one-hour intravenous infusion up to 30 mg/kg/day iron on gestation days 6 to 17 did not result in adverse embryonic or fetal findings.

This daily dose in rats is approximately 40% of the human weekly dose of 750 mg based on body surface area. In rabbits, ferric carboxymaltose was administered as a one-hour infusion on gestation days 6 to 19 at iron doses of 4.5, 9, 13.5, and 18 mg/kg/day. Malformations were seen starting at the daily dose of 9 mg/kg (23% of the human weekly dose of 750 mg).

Spontaneous abortions occurred starting at the daily iron dose of 4.5 mg/kg (12% of the human weekly dose of 750 mg based on body surface area). Pre-implantation loss was at the highest dose. Adverse embryonic or fetal effects were observed in the presence of maternal toxicity.

A pre- and post-natal development study was conducted in rats at intravenous doses up to 18 mg/kg/day of iron (approximately 23% of the weekly human dose of 750 mg based on body surface area). There were no adverse effects on survival of offspring, their behavior, sexual maturation or reproductive parameters.

🧒 Pediatric Use 143 words ▾

8.4Pediatric Use The safety and effectiveness of ferric carboxymaltose injection for IDA in pediatric patients aged 1 year and older who have normal kidney function and have either intolerance to oral iron or have had unsatisfactory response to oral iron have been established. Use of ferric carboxymaltose injection for this indication in this age group is supported by evidence from adequate and well-controlled studies of ferric carboxymaltose injection in adults with additional pharmacodynamic and safety data in pediatric patients aged 1 year and older [see Adverse Reactions ( 6.1 ) and Clinical Pharmacology ( 12.3 )].

Safety and effectiveness of ferric carboxymaltose injection have not been established in pediatric patients less than 1 year of age with IDA. Safety and effectiveness of ferric carboxymaltose injection have not been established to improve exercise capacity in pediatric patients with ID and symptomatic heart failure.

🧓 Geriatric Use 71 words ▾

8.5Geriatric Use Of the 1,775 subjects in clinical studies of ferric carboxymaltose injection , 50% were 65 years and over, while 25% were 75 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 80 words ▾

10 OVERDOSAGE Excessive dosages of ferric carboxymaltose injection may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. A patient who received ferric carboxymaltose injection 18,000 mg over 6 months developed hemosiderosis with multiple joint disorder, walking disability, and asthenia. In the postmarketing setting, hypophosphatemic osteomalacia has been reported in patients who have received repeated high-cumulative courses of ferric carboxymaltose injection.

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 Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron.

12.2Pharmacodynamics Using positron emission tomography (PET) it was demonstrated that red cell uptake of 59 Fe and 52 Fe from ferric carboxymaltose injection ranged from 61% to 99%. In patients with iron deficiency, red cell uptake of radiolabeled iron ranged from 91% to 99% at 24 days after ferric carboxymaltose injection dose. In patients with renal anemia, red cell uptake of radiolabeled iron ranged from 61% to 84% at 24 days after ferric carboxymaltose injection dose.

12.3Pharmacokinetics After administration of a single dose of ferric carboxymaltose injection of 100 to 1,000 mg of iron in iron deficient adult patients, maximum iron concentration of 37 µg/mL to 333 µg/mL were obtained respectively after 15 minutes to 1.21 hours post dose. The volume of distribution was estimated to be 3 L. The iron injected or infused was rapidly cleared from the plasma, the terminal half-life ranged from 7 to 12 hours.

Renal elimination of iron was negligible. After administration of a single dose of ferric carboxymaltose injection 15 mg/kg in pediatric patients 1-17 years of age, the maximum concentrations ranged between 124 and 418.1 μg/mL and the median time to maximum concentration was 7 minutes. The elimination half-life of ferric carboxymaltose injection in pediatric patients was approximately 9.7 hours.

The total median 72-hour exposure (AUC 0-72h ) after a single dose of ferric carboxymaltose injection 15 mg/kg in pediatric patients was 4,529.7 μg∙h/mL while the median exposure after a single dose of 1,000 mg in adults was 5,875.3 μg∙h/mL.

🧬 Mechanism of Action 22 words ▾

12.1Mechanism of Action Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron.

📦 How Supplied / Storage and Handling 52 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Ferric carboxymaltose injection is a dark brown, non-transparent, sterile, aqueous solution. NDC 0781-3542-94 750 mg iron/15 mL Single-Dose Vial Individually Boxed Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See the USP controlled room temperature.] Do not freeze.

📋 Description 164 words ▾

11 DESCRIPTION Ferric carboxymaltose, an iron replacement product, is an iron carbohydrate complex with the chemical name of polynuclear iron (III)-hydroxide 4(R)-(poly-(1→4)- O -α-D-glucopyranosyl)-oxy-2(R),3(R),5(R),6-tetrahydroxy-hexanoate. It has a relative molecular weight of approximately 150,000 Da corresponding to the following empirical formula: [FeO x (OH) y (H 2 O) z ] n [{(C 6 H 10 O 5 ) m (C 6 H 12 O 7 )} l ] k , where n ≈ 10 3 , m ≈ 8, l ≈ 11, and k ≈ 4 ( l represents the mean branching degree of the ligand).

The chemical structure is presented below: Ferric carboxymaltose injection is a dark brown, sterile, aqueous, isotonic colloidal solution for intravenous injection. Each mL contains 50 mg iron as ferric carboxymaltose in water for injection. Ferric carboxymaltose injection is available in, 15 mL single-dose vials.

Sodium hydroxide and/or hydrochloric acid may have been added to adjust the pH to 5.0-7.0. Vial closure is not made with natural rubber latex. structure

💬 Information for Patients 199 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information) and discuss with the patient the etiology of the iron deficiency anemia and the patient’s iron deficiency anemia treatment options. Symptomatic Hypophosphatemia Advise patients to report any signs or symptoms of hypophosphatemia such as fatigue, muscle weakness or pain, bone and joint pain, or bone fractures [see Warnings and Precautions ( 5.1 ) ]. Prior History of Reactions to Parenteral Iron Products Question patients regarding any prior history of reactions to parenteral iron products [see Warnings and Precautions ( 5.2 )] .

Serious Hypersensitivity Reactions Advise patients to report any signs and symptoms of hypersensitivity that may develop during and following ferric carboxymaltose injection administration, such as rash, itching, dizziness, lightheadedness, swelling, and breathing problems [ see Warnings and Precautions ( 5.2 )]. Pregnancy Advise pregnant women about the risk of hypersensitivity reactions which may have serious consequences for the fetus. Advise patients who may become pregnant to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations ( 8.1 )].

Manufactured by American Regent, Inc. New Albany, OH 43054 USA for Sandoz Inc., Princeton, NJ 08540 USA RQ1149-B

🧬 Pharmacokinetics 172 words ▾

12.3Pharmacokinetics After administration of a single dose of ferric carboxymaltose injection of 100 to 1,000 mg of iron in iron deficient adult patients, maximum iron concentration of 37 µg/mL to 333 µg/mL were obtained respectively after 15 minutes to 1.21 hours post dose. The volume of distribution was estimated to be 3 L. The iron injected or infused was rapidly cleared from the plasma, the terminal half-life ranged from 7 to 12 hours.

Renal elimination of iron was negligible. After administration of a single dose of ferric carboxymaltose injection 15 mg/kg in pediatric patients 1-17 years of age, the maximum concentrations ranged between 124 and 418.1 μg/mL and the median time to maximum concentration was 7 minutes. The elimination half-life of ferric carboxymaltose injection in pediatric patients was approximately 9.7 hours.

The total median 72-hour exposure (AUC 0-72h ) after a single dose of ferric carboxymaltose injection 15 mg/kg in pediatric patients was 4,529.7 μg∙h/mL while the median exposure after a single dose of 1,000 mg in adults was 5,875.3 μg∙h/mL.

🧬 Pharmacodynamics 77 words ▾

12.2Pharmacodynamics Using positron emission tomography (PET) it was demonstrated that red cell uptake of 59 Fe and 52 Fe from ferric carboxymaltose injection ranged from 61% to 99%. In patients with iron deficiency, red cell uptake of radiolabeled iron ranged from 91% to 99% at 24 days after ferric carboxymaltose injection dose. In patients with renal anemia, red cell uptake of radiolabeled iron ranged from 61% to 84% at 24 days after ferric carboxymaltose injection dose.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Iron Deficiency Anemia The safety and efficacy of ferric carboxymaltose injection for treatment of IDA were evaluated in two randomized, open-label, controlled clinical trials (Trial 1 and Trial 2). In these two trials, ferric carboxymaltose injection was administered at a dose of 15 mg/kg body weight up to a maximum single dose of 750 mg of iron on two occasions separated by at least 7 days up to a cumulative dose of 1,500 mg of iron. Trial 1: Iron Deficiency Anemia in Patients Who Are Intolerant to Oral Iron or Have Had Unsatisfactory Response to Oral Iron Trial 1: A Multi-center, Randomized, Active Controlled Study to Investigate the Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients with Iron Deficiency Anemia (IDA), (NCT00982007) was a randomized, open-label, controlled clinical study in patients with IDA who had an unsatisfactory response to oral iron (Cohort 1) or who were intolerant to oral iron (Cohort 2) during the 14-day oral iron run-in period.

Inclusion criteria prior to randomization included hemoglobin (Hb) <12 g/dL, ferritin ≤100 ng/mL or ferritin ≤300 ng/mL when transferrin saturation (TSAT) ≤30%. Cohort 1 subjects were randomized to ferric carboxymaltose injection or oral iron for 14 more days. Cohort 2 subjects were randomized to ferric carboxymaltose injection or another IV iron per standard of care [90% of subjects received iron sucrose].

The mean age of study patients was 43 years (range, 18 to 94); 94% were female; 42% were Caucasian, 32% were African American, 24% were Hispanic, and 2% were other races. The primary etiologies of IDA were heavy uterine bleeding (47%) and gastrointestinal disorders (17%). Table 5 shows the baseline and the change in hemoglobin from baseline to highest value between baseline and Day 35 or time of intervention.

Table 5. Mean Change in Hemoglobin From Baseline to the Highest Value Between Day 35 or Time of Intervention (Modified Intent‑to‑Treat Population) Hemoglobin (g/dL) Mean (SD) Cohort 1 Cohort 2 Ferric Carboxymaltose Injection (N=244) Oral Iron (N=251) Ferric Carboxymaltose Injection (N=245) IV SC a (N=237) Baseline 10.6 (1.0) 10.6 (1.0) 9.1 (1.6) 9.0 (1.5) Highest Value 12.2 (1.1) 11.4 (1.2) 12.0 (1.2) 11.2 (1.3) Change (from baseline to highest value) 1.6 (1.2) 0.8 (0.8) 2.9 (1.6) 2.2 (1.3) p-value 0.001 0.001 SD=standard deviation; a Intravenous iron per standard of care Increases from baseline in mean ferritin (264.2 ± 224.2 ng/mL in Cohort 1 and 218.2 ± 211.4 ng/mL in Cohort 2), and transferrin saturation (13 ± 16% in Cohort 1 and 20 ± 15% in Cohort 2) were observed at Day 35 in ferric carboxymaltose injection-treated patients.

Trial 2: Iron Deficiency Anemia in Patients with Non-Dialysis Dependent Chronic Kidney Disease Trial 2: REPAIR-IDA, Randomized Evaluation of efficacy and safety of Ferric Carboxymaltose in Patients with Iron Deficiency Anemia and Impaired Renal function, (NCT00981045) was a randomized, open-label, controlled clinical study in patients with non-dialysis dependent chronic kidney disease. Inclusion criteria included hemoglobin (Hb) ≤11.5 g/dL, ferritin ≤100 ng/mL or ferritin ≤300 ng/mL when transferrin saturation (TSAT) ≤30%.

Study patients were randomized to either ferric carboxymaltose injection or Venofer. The mean age of study patients was 67 years (range, 19 to 101); 64% were female; 54% were Caucasian, 26% were African American, 18% Hispanics, and 2% were other races. Table 6 shows the baseline and the change in hemoglobin from baseline to highest value between baseline and Day 56 or time of intervention.

Table 6. Mean Change in Hemoglobin From Baseline to the Highest Value Between Baseline and Day 56 or Time of Intervention (Modified Intent‑to‑Treat Population) Hemoglobin (g/dL) Mean (SD) Ferric Carboxymaltose Injection (N=1,249) Venofer (N=1,244) Baseline 10.3 (0.8) 10.3 (0.8) Highest Value 11.4 (1.2) 11.3 (1.1) Change (from baseline to highest value) 1.1 (1.0) 0.9 (0.92) Treatment Diffe… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 144 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, and Impairment of Fertility Carcinogenicity studies have not been performed with ferric carboxymaltose. Ferric carboxymaltose was not genotoxic in the following genetic toxicology studies: in vitro microbial mutagenesis (Ames) assay, in vitro chromosome aberration test in human lymphocytes, in vitro mammalian cell mutation assay in mouse lymphoma L5178Y/TK+/- cells, in vivo mouse micronucleus test at single intravenous doses up to 500 mg/kg. In a combined male and female fertility study, ferric carboxymaltose was administered intravenously over one hour to male and female rats at iron doses of up to 30 mg/kg.

Animals were dosed 3 times per week (on Days 0, 3, and 7). There was no effect on mating function, fertility or early embryonic development. Based on body surface area, the dose of 30 mg/kg in animals is approximately 40% of the human dose of 750 mg.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 141 words ▾

13.1Carcinogenesis, Mutagenesis, and Impairment of Fertility Carcinogenicity studies have not been performed with ferric carboxymaltose. Ferric carboxymaltose was not genotoxic in the following genetic toxicology studies: in vitro microbial mutagenesis (Ames) assay, in vitro chromosome aberration test in human lymphocytes, in vitro mammalian cell mutation assay in mouse lymphoma L5178Y/TK+/- cells, in vivo mouse micronucleus test at single intravenous doses up to 500 mg/kg. In a combined male and female fertility study, ferric carboxymaltose was administered intravenously over one hour to male and female rats at iron doses of up to 30 mg/kg.

Animals were dosed 3 times per week (on Days 0, 3, and 7). There was no effect on mating function, fertility or early embryonic development. Based on body surface area, the dose of 30 mg/kg in animals is approximately 40% of the human dose of 750 mg.

📄 Patient Package Insert ~3 min read ▾

Patient Information Patient Information Ferric Carboxymaltose (FER-ik kar-BOX-ee-MAWL-tose) Injection What is the most important information I should know about ferric carboxymaltose injection? Ferric carboxymaltose injection can cause serious side effects, including: Low blood phosphate levels (hypophosphatemia). Hypophosphatemia has happened after one or more doses of ferric carboxymaltose injection and can be severe or serious, and lead to hospitalization, softening of your bones (osteomalacia), and broken bones (fractures).

Hypophosphatemia can happen even if your blood phosphate levels were normal before treatment and you do not have any risk factors for hypophosphatemia. Your healthcare provider will check your blood phosphate levels before a repeat treatment with ferric carboxymaltose injection if you are at risk for hypophosphatemia. If a repeat treatment is needed within 3 months of your last treatment, your healthcare provider will check your blood phosphate levels.

Tell your healthcare provider if you develop any of the following signs or symptoms of hypophosphatemia during treatment with ferric carboxymaltose injection: tiredness bone or joint pain muscle weakness or pain broken bones Your healthcare provider may permanently stop treatment with ferric carboxymaltose injection if you develop severe hypophosphatemia with symptoms or if your blood phosphate levels remain low during treatment with ferric carboxymaltose injection. See “ What are the possible side effects of ferric carboxymaltose injection? ” for more information about side effects.

What is ferric carboxymaltose injection? Ferric carboxymaltose injection is a prescription iron replacement medicine used for the treatment of: iron deficiency anemia (IDA) in: adults and children 1 year of age and older who cannot tolerate iron taken by mouth (oral) or who have not responded well to oral iron . adults who have chronic kidney disease who are not on dialysis (non-dialysis dependent chronic kidney disease). iron deficiency in adults with mild to moderate heart failure to improve the ability to exercise (improve exercise capacity).

It is not known if ferric carboxymaltose injection is safe and effective in children with IDA who are under 1 year of age. It is not known if ferric carboxymaltose injection is safe and effective in children with iron deficiency and mild to moderate heart failure to improve exercise capacity. Who should not receive ferric carboxymaltose injection?

Do not receive ferric carboxymaltose injection if you are allergic to ferric carboxymaltose or any of the ingredients in ferric carboxymaltose injection. See the end of this Patient Information leaflet for a complete list of ingredients in ferric carboxymaltose injection. Before receiving ferric carboxymaltose injection, tell your healthcare provider about all of your medical conditions, including if you: have a history of trouble absorbing certain vitamins or phosphate in your body have inflammatory bowel disease have hyperparathyroidism have low vitamin D levels have hereditary hemorrhagic telangiectasia (HHT) or Osler-Weber-Rendu syndrome have had an allergic reaction to iron given into your vein have previously received ferric carboxymaltose injection have high blood pressure (hypertension) are pregnant or plan to become pregnant.

Ferric carboxymaltose injection may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with ferric carboxymaltose injection. are breastfeeding or plan to breastfeed. Ferric carboxymaltose injection passes into your breast milk.

It is not known if ferric carboxymaltose injection will harm your baby.Talk to your healthcare provider about the best way to feed your baby during treatment with ferric carboxymaltose injection. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How will I re… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 28 words ▾

Boxed Warning, Symptomatic Hypophosphatemia 08/2026 Warnings and Precautions, Symptomatic Hypophosphatemia ( 5.1 ) 08/2026 Boxed Warning, Symptomatic Hypophosphatemia 08/2026 Warnings and Precautions, Symptomatic Hypophosphatemia ( 5.1 ) 08/2026

📄 Package Label / Principal Display Panel 65 words ▾

PRINCIPAL DISPLAY PANEL - 15 ML CONTAINER LABEL NDC 0781-3542-94 Rx Only Ferric Carboxymaltose Injection 750 mg/15 mL (50 mg/mL) For Intravenous Use Only Single Dose Vial. Discard Unused Portion. SANDOZ vial label

PRINCIPAL DISPLAY PANEL - 15 ML CARTON LABELING NDC 0781-3542-94 Rx Only Ferric Carboxymaltose Injection 750 mg/15 mL (50 mg/mL) For Intravenous Use Only Single Dose Vial. Discard Unused Portion. SANDOZ carton

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 Ferric Carboxymaltose (this brand).

Top reported reactions

Hypophosphataemia563
Pain261
Product Quality Issue226
Anxiety202
Emotional Distress198
Anhedonia197
Arthralgia170

Age at onset

Neonate5
Infant2
Child1
Adolescent10
Adult110
Elderly54

Reporter sex

1,619 reports
Male · 17%
Female · 83%

Serious outcomes

Hospitalization298
Disabling224
Life-threatening208
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 535 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ 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.
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.
← 00781-3541-25 · Sandoz 00781-3543-25 · 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.