Home › NDC Lookup › Ingredients › Ferric Maltol › 73059-0001-10
ACCRUFER Ferric Maltol 30 mg Capsule, 10-count — NDC 73059-0001-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ACCRUFER Ferric Maltol 30 mg Capsule, 10-count — NDC 73059-001-10 (Billing 73059-0001-10)

by Shield TX (UK) Ltd · 1 BOTTLE, PLASTIC in 1 CARTON / 10 CAPSULE in 1 BOTTLE, PLASTIC

This is a package of 10 capsules of ACCRUFER Ferric Maltol 30 mg Capsule from Shield TX (UK) Ltd, marketed since Jul 2021 and currently FDA-listed.

NDC 73059-0001-10
🏷️ FDA NDC (as labeled) 73059-001-10 billing pads the product segment with a zero
This package
Contains10-count Pack sizes3 compare ↓
Product page 73059-0001-60 Also comes in: 6 capsules 73059-001-06 60 capsules 73059-001-60
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 73059-001-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
73059 labeler · 001 product · 10 package
Package marketed since
Apr 1, 2022
Sample package
Yes — professional sample, not for sale
Listing certified through
Dec 31, 2027
Billing quantity
10 EA per package
Barcode (UPC)
0373059001602
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 73059-001-10
Product NDC 73059-001
11-digit billing NDC 73059000110
NCPDP billing unit EA — each (per item)
RxCUI 2539943, 2539949
UNII MA10QYF1Z0
UPC 0373059001602
Application # NDA212320
SPL Set ID 367ac157-2d25-4f34-99ce-b126e0f03851
Established class (EPC) Parenteral Iron Replacement; Phosphate Binder
Mechanism of action Phosphate Chelating Activity
Chemical class Iron
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-07-01
Route ORAL
Dosage form CAPSULE
Substance FERRIC MALTOL

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

GPI-14 82300063000120
GPI class ACCRUFeR
GCN Seq No 077127
GCN 43028
HICL code 044098
Ingredient (HICL) Ferric Maltol
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 ACCRUFER 30 MG CAPSULE
FDB brand name Accrufer
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 077127
  • GCN: 43028
  • GPI-14 (Medi-Span): 82300063000120
  • HICL (First Databank): 044098
  • AHFS class code: 20:04.04.00
  • RxCUI (RxNorm): 2539943
Why two NDCs? The FDA registers this code as 73059-001-10 — a 5-3-2 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 product segment → 73059-0001-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Iron trivalent, oral preparations class.

Drug family (ATC) Iron trivalent, oral preparations
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 ACCRUFER 30 MG CAPSULE Ingredient Ferric Maltol
📖 What it is MedlinePlus · NLM

Ferric maltol is used to treat or prevent anemia (a lower-than-normal number of red blood cells) when the amount of iron taken in from your diet is not enough. Ferric maltol is in a class of medications called iron replacement products. It works by providing iron to help the body to produce red blood cells.

Read the full MedlinePlus article ↗
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: 6 capsules 60 capsules
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 Per unit Per pack Marketing startMarketing endStatus
73059-0001-06 73059-001-06 1 BOTTLE, PLASTIC in 1 CARTON / 6 CAPSULE in 1 BOTTLE, PLASTIC — — 2021-11-01 — Discontinued by firm
73059-0001-10 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON / 10 CAPSULE in 1 BOTTLE, PLASTIC Sample — — 2022-04-01 — Active
73059-0001-60 73059-001-60 Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 60 CAPSULE in 1 BOTTLE, PLASTIC $10.09 / ea $605.10 2021-07-01 — 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 is a 10-count package — 1 bottle, plastic in 1 carton / 10 capsule in 1 bottle, plastic.
How does this package differ from NDC 73059-0001-06?
Both are ACCRUFER Ferric Maltol 30 mg Capsule — the drug itself is identical. This page's package is the 10-count one, while NDC 73059-0001-06 is the 6 capsules package.
What NDC number is used to bill for this package of ACCRUFER Ferric Maltol 30 mg Capsule?
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.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Accrufer 30 mgthis 73059-0001-10 Shield 10 capsules — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2019
First FDA approval
Jul 2019
📍
2026
Currently FDA-listed
7 years listed
🛡️
2035
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Oct 2035. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jul 25, 2019 RLD RS ⏳ ~9 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 10179120 — method of use (U-2603)
US 9802973 — drug substance (U-2603)
US 9248148 — method of use (U-2603)
Exclusivity NPP
2019 2021 2023 2025 2027 2029 2031 2033 2035
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 (3)
PatentTypeUse codeExpires
US 10179120 ↗ Method of use U-2603 Jan 6, 2035
US 9802973 ↗ Drug substance U-2603 Oct 23, 2035
US 9248148 ↗ Method of use U-2603 Mar 29, 2031
FDA exclusivity
CodeWhat it grantsExpires
NPPNew Patient PopulationDec 19, 2028
Common questions
Is there a generic version of ACCRUFER 30 MG CAPSULE?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for ACCRUFER 30 MG CAPSULE. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Oct 2035 — an estimate, not a guaranteed launch date.
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.

What it looks like

Color red
ShapeCapsule
Imprint30
Size19 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

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

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

  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerShield TX (UK) Ltd
Application holderSHIELD TX UK LTD
FDA applicationNDA212320 (NDA)
Labeler code73059
First marketedJul 2021
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 51 words ▾

1 INDICATIONS AND USAGE ACCRUFER is indicated for the treatment of iron deficiency in adult and pediatric patients 10 years of age and older. ACCRUFER is an iron replacement product indicated for the treatment of iron deficiency in adult and pediatric patients 10 years of age and older. ( 1 )

⏱️ Dosage and Administration 132 words ▾

2 DOSAGE AND ADMINISTRATION 30 mg orally twice daily on an empty stomach 1 hour before or 2 hours after meals ( 2.1 ) Swallow capsules whole. Do not open, break, or chew capsules. ( 2.1 ) Continue as long as necessary to replenish body iron stores ( 2.1 )

2.1Recommended Dosage Adults and Children Aged 10 Years and Above ​ The recommended dosage of ACCRUFER is 30 mg orally twice daily, on an empty stomach 1 hour before or 2 hours after meals. Swallow capsules whole. Do not open, break, or chew capsules.

Treatment duration will depend on the severity of iron deficiency but generally at least 12 weeks of treatment is required. The treatment should be continued as long as necessary until ferritin levels are within the normal range.

💊 Dosage Forms and Strengths 26 words ▾

3 DOSAGE FORMS AND STRENGTHS Capsules: ACCRUFER contains 30 mg iron, as ferric maltol, in red capsules printed with “30”. Capsules: 30 mg ( 3 )

⛔ Contraindications 115 words ▾

4 CONTRAINDICATIONS ACCRUFER is contraindicated in patients with a history of: Hypersensitivity to the active substance or to any of the excipients [see Description ( 11 )] . Reactions could include shock, clinically significant hypotension, loss of consciousness, and/or collapse. Hemochromatosis and other iron overload syndromes [see Warnings and Precautions ( 5.1 )] .

Use may result in iron overdose [see Overdosage ( 10 )]. Receiving repeated blood transfusions. Use may result in iron overload [see Warnings and Precautions ( 5.2 ) and Overdosage ( 10 )].

Hypersensitivity to the active substance or any excipient ( 4 ) Hemochromatosis and other iron overload syndromes ( 4 ) Patients receiving repeated blood transfusions ( 4 )

⚠️ Warnings and Cautions 203 words ▾

5 WARNINGS AND PRECAUTIONS IBD Flare: Avoid use in patients with IBD flare ( 5.1 ) Iron Overload: Do not administer to patients with iron overload or those receiving intravenous iron. ( 5.2 ) Risk of Overdosage in Children Due to Accidental Ingestion: Keep out of reach of children. ( 5.3 )

5.1Increased Risk of Inflammatory Bowel Disease (IBD) Flare Avoid use of ACCRUFER in patients with an active inflammatory bowel disease (IBD) flare, as there is potential risk of increased inflammation in the gastrointestinal tract.

5.2Iron Overload Excessive therapy with iron products can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Do not administer ACCRUFER to patients with evidence of iron overload or patients receiving intravenous iron [see Contraindications ( 4 )] . Assess iron parameters prior to initiating ACCRUFER and monitor iron parameters while on therapy [see Overdosage ( 10 ) and Clinical Pharmacology ( 12.2 )] .

5.3Risk of Overdosage in Children Due to Accidental Ingestion Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Increased Risk of Inflammatory Bowel Disease Flare [see Warnings and Precautions ( 5.1 )] Iron Overload [see Warnings and Precautions ( 5.2 )] Most common adverse reactions (incidence > 1%) are flatulence, diarrhea, constipation, feces discolored, abdominal pain, nausea, vomiting and abdominal discomfort/distension. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Shield Therapeutics Inc at 1-888-963-6267 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. The data described below reflect exposure to ACCRUFER in 175 adult patients in the placebo-controlled phase of three randomized studies conducted in patients with anemia and quiescent inflammatory bowel disease (IBD) (Studies AEGIS 1 & 2) or non-dialysis dependent chronic kidney disease (CKD) (AEGIS 3).

The pooled patient population had a mean age of 58 years, 67.4% were female (n=118), and 81.7% (n=143) were Caucasian. Table 1 presents all adverse reactions occurring in the placebo-controlled period of the pooled randomized studies [see Clinical Studies ( 14 )] occurring at a rate of > 1% in the treated group, and for which the rate for ACCRUFER exceeds the rate for placebo. Table 1.

Adverse Reactions Reported by ≥1% of Patients Treated with ACCRUFER During Placebo-Controlled Period of Pooled Studies (Studies AEGIS1/2 and AEGIS 3) ACCRUFER 30 mg Twice Daily (N = 175) Placebo (N = 120) Body System Adverse Reaction Gastrointestinal Flatulence 4.6% 0.0% Diarrhea 4.0% 1.7% Constipation 4.0% 0.8% Feces discolored 4.0% 0.8% Abdominal pain 2.9% 2.5% Nausea 1.7% 0.8% Vomiting 1.7% 0.0% Abdominal discomfort 1.1% 0.0% Abdominal distension 1.1% 0.0% The proportion of patients who discontinued treatment due to adverse reactions during the double-blind, placebo-controlled portion of studies was 4.6% for patients taking ACCRUFER.

The most common adverse reaction leading to discontinuation of ACCRUFER in these studies was abdominal pain (1.7% of patients). Pediatric Patients with Iron Deficiency Anemia The safety profile of ACCRUFER in pediatric patients was assessed in 24 patients aged 10 to <18 years of age enrolled to the FORTIS trial and treated with ACCRUFER. Overall, the safety profile reported in pediatric patients was consistent with the safety profile reported in adult patients with iron deficiency anemia.

🔄 Drug Interactions 206 words ▾

7 DRUG INTERACTIONS Dimercaprol : Avoid concomitant use. ( 7.2 ) Oral Medications : Separate administration of ACCRUFER from certain oral medications. Monitor clinical responses as appropriate. ( 7.1 , 7.2 )

7.1Effect of Other Drugs on ACCRUFER Oral Medications There are no empirical data on avoiding drug interactions between ACCRUFER and concomitant oral medications. Concomitant use of some drugs may reduce the bioavailability of iron after administration of ACCRUFER. Separate the administration of ACCRUFER from these drugs.

The duration of separation may depend on the absorption characteristics of the medication concomitantly administered, such as time to peak concentration or whether the drug is an immediate or extended release product. Monitor clinical response to ACCRUFER.

7.2Effect of ACCRUFER on Other Drugs Dimercaprol Concomitant use of iron products with dimercaprol may increase the risk of nephrotoxicity. Avoid concomitant use of ACCRUFER with dimercaprol. Oral Medications Concomitant use of ACCRUFER may decrease the bioavailability of some drugs, including mycophenolate, ethinyl estradiol, ciprofloxacin and doxycycline [see Clinical Pharmacology ( 12.3 )] .

For oral drugs where reductions in bioavailability may cause clinically significant effects on its safety or efficacy, separate the administration of ACCRUFER by at least 4 hours. Monitor clinical responses to concomitant drugs as appropriate.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary ACCRUFER is not absorbed systemically as an intact complex following oral administration, and maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology ( 12.3 )] . In animal reproduction studies, oral administration of ferric or ferrous compounds to gravid CD1-mice and Wistar-rats during organogenesis at doses 13 to 32 times the recommended human dose resulted in no adverse developmental outcomes. An overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation (see Data) .

In animal reproduction studies, oral administration of maltol to pregnant Crl: COBS-CD (SD) BR rats during organogenesis at doses 6 times the recommended human dose resulted in no adverse developmental outcomes (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population 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 2-4% and 15-20%, 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.

Data Animal Data In embryofetal development studies in mice and rats, pregnant animals received oral doses of ferric or ferrous compounds (ferrous sulfate or ferric sodium pyrophosphate) of up to 160 mg/kg/day in mice, or up to 200 mg/kg/day in rats, during the period of organogenesis. Administration of ferric or ferrous compounds at doses 13 times (in mice) or 32 times (in rats) the recommended human dose resulted in no maternal toxicity and no adverse developmental outcomes. In a multigeneration reproductive and developmental study in rats, pregnant animals received oral doses of maltol of 100, 200, and 400 mg/kg/day, during the period of organogenesis.

Administration of maltol at doses 6 times the recommended human dose resulted in no maternal toxicity and no adverse developmental outcomes.

8.2Lactation Risk Summary There are no data on the presence of ACCRUFER in human milk, the effects on the breastfed child, or the effects on milk production. ACCRUFER is not absorbed systemically as an intact complex by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to ACCRUFER.

8.4Pediatric Use The safety and effectiveness of ACCRUFER for the treatment of iron deficiency have been established in pediatric patients 10 years and older. Use of ACCRUFER for this indication is supported by evidence from adequate and well-controlled studies of ACCRUFER in adults with additional data from an adequate and well-controlled study conducted in pediatric patients aged 10 years and older [ see Clinical Studies ( 14.3 )]. Safety and effectiveness of ACCRUFER have not been established in pediatric patients under 10 years.

8.5Geriatric Use Of the 295 patients in the randomized trials of ACCRUFER, 39% of patients were aged 65 and older, while 23% were aged 75 and older. No overall differences in safety or effectiveness were observed between these patients and younger patients.

🆘 Overdosage 131 words ▾

10 OVERDOSAGE No data are available regarding overdose of ACCRUFER in patients. Acute iron ingestion of 20 mg/kg elemental iron is potentially toxic and 200- 250 mg/kg is potentially fatal. Early signs and symptoms of iron overdose may include nausea, vomiting, abdominal pain and diarrhea.

In more serious cases there may be evidence of hypoperfusion, metabolic acidosis and systemic toxicity. Dosages of ACCRUFER in excess of iron needs may lead to accumulation of iron in storage sites leading to hemosiderosis. Periodic monitoring of iron parameters such as serum ferritin and transferrin saturation may assist in recognizing iron accumulation.

Do not administer ACCRUFER to patients with iron overload [ see Contraindications ( 4 ) ] . Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action ACCRUFER delivers iron for uptake across the intestinal wall and transfer to transferrin and ferritin.

12.2Pharmacodynamics ACCRUFER has been shown to increase serum iron parameters, including ferritin and transferrin saturation (TSAT) in adults and pediatric patients 10 years and older.

12.3Pharmacokinetics Adults The pharmacokinetic properties of serum iron after administration of ACCRUFER was assessed in subjects with iron deficiency (with or without anemia) following a single dose and at steady state (after 1 week) of ACCRUFER 30 mg, 60 mg, or 90 mg twice daily (1 to 3 times the approved recommended dosage). Total serum iron concentrations increase in a less than dose proportional manner with increasing ACCRUFER doses. Total serum iron peak values were reached 1.5 to 3 hours after administration of ACCRUFER, and were comparable between Day 1 and Day 8.

Pediatric Population In a pharmacokinetic substudy of the FORTIS trial [see Clinical Studies ( 14.3 )] in pediatric patients with iron-deficiency anemia, ferric maltol 15 mg or 30 mg was administered orally twice daily, for 7-10 days in children aged 10 to <18 years. After a single dose of 30 mg on Day 1, baseline-corrected serum iron reached peak concentration (C max = 119 µg/dL) at 2 hours, with a AUC 0-t of 374 h·µg/dL in children aged 12 to <18 years. After a single dose of 15 mg on Day 1, baseline-corrected serum iron reached peak concentration (C max = 40 µg/dL) at 2.1 hours, with a AUC 0-t of 60.1 h·µg/dL in children aged 10 to 11 years.

No accumulation of maltol glucuronide was observed. Absorption ACCRUFER dissociates upon uptake from the gastrointestinal tract allowing iron and maltol to be absorbed separately. Effect of Food Food has been shown to decrease the bioavailability of iron after administration of ferric maltol capsules.

Drug Interaction Studies In vitro Of the drugs screened for an interaction with ferric maltol in vitro at pH 1.2, 4.5 and 6.8, only mycophenolate and ethinyl estradiol showed any potential for interaction. Mycophenolate recovery was reduced by up to 16% at pH 1.2 but there was no interaction at pH 4.5; due to solubility issues data are not available for pH 6.8. Ethinyl estradiol recovery was reduced by up to 35% at pH 4.5; due to solubility issues data are not available for pH 1.2 and pH 6.8.

These potential oral interactions can be avoided by spacing the administration of those drugs and ACCRUFER [see Drug Interactions ( 7.2 )] . Lisinopril, metoprolol and warfarin showed no interaction at any of the 3 pH conditions and can be taken with ACCRUFER. No interaction with ferric maltol was observed for atorvastatin (pH 6.8), and norgestimate (pH 1.2) (data were not obtainable at the other pH conditions due to solubility issues).

In vivo No clinical studies evaluating the drug interaction potential of ACCRUFER have been conducted. Iron-containing preparations may decrease ciprofloxacin absorption into the bloodstream, resulting in lower serum and urine levels and reduced effectiveness. Absorption of tetracyclines including doxycycline is reported to be impaired by iron-containing preparations.

12.6Maltol Phamacokinetics Maltol is metabolized through glucuronidation (UGT1A6) and sulphation in vitro . Of the total maltol ingested, a mean of between 39.8% and 60% was excreted in the urine as maltol glucuronide. There was no clinically meaningful change in exposure of maltol or maltol glucuronide in subjects with non-dialysis dependent chronic kidney disease (eGFR of > 15 mL/min/1.73m 2 and <60 mL/min/1.73m 2 ).

📦 How Supplied / Storage and Handling 69 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied ACCRUFER (ferric maltol) 30 mg iron capsules are supplied as 60 red capsules, printed with “30”, in HDPE bottles with a child-proof polypropylene push-lock. 1 Bottle of 60-count 30 mg ferric iron capsules (NDC 73059-001-60).

16.2Storage and Handling 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 USP controlled room temperature].

📋 Description 130 words ▾

11 DESCRIPTION ACCRUFER (ferric maltol) capsules, an iron replacement product for oral administration, contain 30 mg iron and 201.5 mg maltol. Ferric maltol contains iron in a stable ferric state as a complex with a trimaltol ligand. Ferric maltol is 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1) and has the molecular formula (C 6 H 5 O 3 ) 3 Fe and a molecular mass of 431.2.

Each red capsule, printed with “30”, contains colloidal anhydrous silica, crospovidone (Type A), lactose monohydrate, magnesium stearate and sodium lauryl sulfate as inactive ingredients. In addition, the capsule shell contains FD&C Blue No. 1, FD&C Red No.

40, FD&C Yellow No.6, hypromellose and titanium dioxide. The ink used for printing the marking contains Shellac, ammonium hydroxide, ethanol, iron oxide black and propylene glycol. Image 1

💬 Information for Patients 218 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Administration Inform patients to take ACCRUFER as directed on an empty stomach 1 hour before or 2 hours after meals. Instruct patients on concomitant medications that should be dosed apart from ACCRUFER [see Dosage and Administration ( 2.1 ) and Drug Interactions ( 7.2 )] .

Advise patients to swallow the capsules whole and not to open, break, or chew capsules. Adverse Reactions Advise patients that ACCRUFER may cause, flatulence, diarrhea, constipation, discolored feces, abdominal pain, nausea, vomiting or abdominal bloating or discomfort. Advise patients to report severe or persistent gastrointestinal symptoms or any allergic reactions to their physician [see Adverse Reactions ( 6.1 )].

Increased Risk of IBD Flare Advise patients that they should not use ACCRUFER if they are experiencing an IBD flare [see Warnings and Precautions ( 5.1 )] . Iron Overload and Risk of Accidental Overdose in Children Inform patients to keep this product out of reach of children as accidental overdose of iron products is a leading cause of fatal poisonings in children. In case of accidental overdose, advise them to call a doctor or poison control center immediately [see Warnings and Precautions ( 5.2, 5.3 )].

Distributed by Shield Therapeutics Inc, 7-57 Wells Avenue Newton, MA, 02459

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Patients with Inflammatory Bowel Disease (IBD) The safety and efficacy of ACCRUFER for the treatment of iron deficiency anemia was studied in two randomized, placebo-controlled trials: AEGIS 1 ( NCT01252221 ) and AEGIS 2 ( NCT01340872 ). These trials enrolled 128 patients (age range 18-76 years; 45 males and 83 females) with quiescent IBD (58 patients with Ulcerative Colitis [UC] and 70 patients with Crohns disease [CD]) and baseline Hb concentrations between 9.5 g/dL and 12 /13 g/dL for females / males and ferritin < 30 mcg/L.

All patients had discontinued prior oral ferrous product treatment due to lack of efficacy or inability to tolerate oral iron replacement products. Subjects were randomized 1:1 to receive either 30 mg ACCRUFER twice daily or a matched placebo control for 12 weeks.) and AEGIS 2 ( NCT01340872 ). These trials enrolled 128 patients (age range 18-76 years; 45 males and 83 females) with quiescent IBD (58 patients with Ulcerative Colitis [UC] and 70 patients with Crohns disease [CD]) and baseline Hb concentrations between 9.5 g/dL and 12 /13 g/dL for females / males and ferritin < 30 mcg/L.

All patients had discontinued prior oral ferrous product treatment due to lack of efficacy or inability to tolerate oral iron replacement products. Subjects were randomized 1:1 to receive either 30 mg ACCRUFER twice daily or a matched placebo control for 12 weeks. The major efficacy outcome was the mean difference in Hb concentration from baseline to week 12 between ACCRUFER and placebo.

The Least Square [LS] mean difference from baseline was 2.18 g/dL (p<0.0001)(see Table 2). Table 2. Summary of Hemoglobin Concentration (g/dL) and Change from Baseline to Week 12 AEGIS 1 & 2 - Analysis Using Multiple Imputation - Full Analysis Set Population Visit (Week) Statistic ACCRUFER (N = 64) Placebo (N =64) Baseline Mean (SD) 11.0 (1.03) 11.10 (0.85) Mean change from baseline to Week 12 LS Mean (SE) 2.25 (0.12) 0.06 (0.13) Treatment Comparison Difference in Change from Baseline LSM Difference (SE) ACCRUFER Placebo) 1-sided lower 97.5%CI p-value ACCRUFER versus placebo 2.18 (0.19) (1.81) <0.0001 Note: Multiple imputation was based on treatment, gender, disease [UC or CD], and Hb concentration at baseline, Week 4, and 8.

For each imputed dataset, the change from baseline to Week 12 was analyzed using an ANCOVA model with treatment as the factor and gender, disease, baseline Hb concentration as covariates. The LS mean difference in change from baseline Hb to Week 4 and 8 between ACCRUFER and placebo were 1.04 g/dl and 1.73 g/dl, respectively. The mean ferritin (mcg/L) levels in ACCRUFER subjects at baseline were 8.6 mcg/L [SD 6.77]) and the mean ferritin (mcg/L) levels at Week 12 were 26.0 mcg/L [SD 30.57] with a mean overall improvement of 17.3 mcg/L.

Following completion of the 12-week placebo-controlled phase of the studies, eligible patients transitioned to ACCRUFER 30 mg twice daily open-label treatment for an additional 52 weeks. During the open-label phase with ACCRUFER, the mean change in Hb concentration from baseline to Week 64 was 3.1 g/dL [SD 1.46 g/dL, n = 35] and the ferritin value demonstrated a mean of 68.9 mcg/L [SD 96.24] at 64 weeks, with a mean overall improvement of 60.4 mcg/L.

14.2Patients with Chronic Kidney Disease (CKD) The safety and efficacy of ACCRUFER for the treatment of iron deficiency anemia was studied in AEGIS 3 ( NCT02968368 ), a trial that enrolled 167 patients (mean age 67.4 years, range 30-90 years; 50 males and 117 females) with non-dialysis dependent chronic kidney disease (CKD) and baseline hemoglobin (Hb) concentrations between 8g/dL and 11 g/dL and ferritin < 250 mcg/L with a Transferrin saturation (TSAT) <25% or ferritin < 500 mcg/L with a TSAT <15%. ACCRUFER was administered at a dose of 30 mg twice daily.

Subjects were randomized 2:1 to receive either 30 mg ACCRUFER twice daily or a matched placebo control for 16 weeks. The major efficacy outcome was the mean differ… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Ferric Maltol ACCRUFER is not absorbed systemically as an intact complex. Carcinogenicity studies have not been conducted with ferric maltol. Ferric maltol was mutagenic in vitro in reverse bacterial mutation (Ames) assays.

Ferric maltol increased revertant frequency in the absence and presence of metabolic activation. Fertility studies have not been conducted with ferric maltol. Maltol The carcinogenic potential of maltol has been evaluated in long-term animal toxicity studies in two species: CD-1 mice and Sprague-Dawley rats.

Maltol was not carcinogenic in a 18-month study in mice at doses up to 400 mg/kg (approximately 5.6 times the human daily dose). Maltol was not carcinogenic in a 2-year study in rats at doses up to 400 mg/kg (approximately 11.2 times the human daily dose). Maltol was mutagenic in vitro in reverse bacterial mutation (Ames) assays.

Maltol increased revertant frequency in the absence and presence of metabolic activation. Maltol was clastogenic in vivo in a mouse micronucleus assay (increase in polychromatic erythrocytes) at intraperitoneal doses of 774 mg/kg. Absorbed maltol is rapidly conjugated with glucuronic acid.

It is therefore unlikely that the mutagenic activity of maltol would be expressed under the conditions of oral human intake. In a multi-generation animal reproduction study in male and female rats, there were no effects on mating, fertility, or early embryonic development at doses up to 400 mg/kg/day (approximately 11.2 times the human daily dose).

📄 Patient Package Insert ~3 min read ▾

Patient Information ACCRUFER ® (ak-roo-fer) (ferric maltol) capsules What is ACCRUFER? ACCRUFER is a prescription medicine used in adults and children 10 years of age and older to treat low iron stores in your body. It is not known if ACCRUFER is safe and effective in children under 10 years of age.

Do not take ACCRUFER if you: are allergic to ferric maltol or any of the ingredients in ACCRUFER. See the end of this leaflet for a complete list of ingredients in ACCRUFER. have any illness that causes you to store too much iron in your body or if you have a problem with how your body uses iron. are receiving repeated blood transfusions. Before taking ACCRUFER, tell your healthcare provider about all your medical conditions, including if you: have inflammatory bowel disease (IBD). are pregnant or plan to become pregnant.

It is not known if ACCRUFER will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if ACCRUFER passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with ACCRUFER.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking ACCRUFER with certain other medicines may affect each other causing serious side effects. You may need to take ACCRUFER at least 4 hours before or 4 hours after you take certain medicines.

Ask your healthcare provider for a list of these medicines if you are not sure if you take one of these medicines. Especially tell your healthcare provider if you take: dimercaprol other oral iron tablets or health supplements containing iron Ask your healthcare provider if you are not sure if you take one of these medicines. Know the medicines you take.

Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. How should I take ACCRUFER? Take ACCRUFER exactly as your healthcare provider tells you to.

Take ACCRUFER 2 times a day on an empty stomach 1 hour before or 2 hours after meals. Swallow ACCRUFER capsules whole. Do not open, break, or chew ACCRUFER capsules.

In case of accidental overdose, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. What are the possible side effects of ACCRUFER? ACCRUFER may cause serious side effects, including: Increased risk of inflammatory bowel disease (IBD) flare.

You should avoid taking ACCRUFER if you have inflammatory bowel disease (IBD) and are experiencing a flare. Too much iron stored in your body (iron overload). Your healthcare provider should check the iron level in your blood before you start and during treatment with ACCRUFER.

Risk of overdose in children due to accidental swallowing. Accidental overdose of iron-containing products is a leading cause of death from poisoning in children under 6. Keep ACCRUFER in a safe place and out of the reach of children.

The most common side effects of ACCRUFER include: gas diarrhea constipation discolored stools stomach pain nausea vomiting stomach area discomfort or bloating These are not all the possible side effects of ACCRUFER. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ACCRUFER? Store ACCRUFER at room temperature between 68°F to 77°F (20°C to 25°C). ACCRUFER comes in a child-resistant bottle.

Keep ACCRUFER and all medicines out of reach of children. General information about the safe and effective use of ACCRUFER. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

Do not use ACCRUFER for a condition for which it was not prescribed. Do not give ACCRUFER to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your healthcare provider or pharmacist for information about ACCRUFER that is written for health professiona… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 7 words ▾

Indications and Usage ( 1 ) 12/2025

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL - 60 Capsules Carton Label - ACCRUFER ® (ferric maltol) capsules 30 mg (60 Capsules) NDC 73059-001-60 ACCRUFeR ® (ferric maltol*) capsules 30 mg For oral administration only 60 capsules Distributed by Shield Therapeutics Inc SHIELD THERAPEUTICS Rx only Bottle Label - ACCRUFER ® (ferric maltol) capsules 30 mg NDC 73059-001-60 ACCRUFeR ® (ferric maltol*) capsules 30 mg For oral administration only 60 capsules SHIELD THERAPEUTICS Rx only *Each capsule contains 30 mg iron (as ferric maltol) WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6.

Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. 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 USP controlled room temperature). Usual Dosage: 1 capsule twice daily on an empty stomach. See prescribing information.

Distributed by Shield Therapeutics Inc. Carton Label Bottle Label

PRINCIPAL DISPLAY PANEL - 10 Capsules Carton Label - ACCRUFER ® (ferric maltol) capsules 30 mg (10 Capsules) NDC 73059-001-10 ACCRUFeR® (ferric maltol*) capsules 30 mg For oral administration only 10 capsules Professional Sample - Not For Sale SHIELD THERAPEUTICS Rx only Bottle Label - ACCRUFER ® (ferric maltol) capsules 30 mg (10 Capsules) NDC 73059-001-10 ACCRUFeR® (ferric maltol*) 30 mg capsules For oral administration only 10 capsules Sample-Not for Sale SHIELD THERAPEUTICS Rx only *Each capsule contains 30 mg iron (as ferric maltol).

Store at 20°C to 25°C (68°F to 77°F); Usual Dosage: 1 capsule twice daily on an empty stomach. See Prescribing Information. Distributed by Shield Therapeutics Inc.

10 Count Carton Label 10 Count Bottle 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.
60 capsules73059-0001-60 59,215 Rx · $38,688,646
6 capsules73059-0001-06 No Medicaid data
10 capsules this page73059-0001-10 No Medicaid data
Drug total (last 4 qtrs): 59,215 Rx · 3,957,346 units · $38,688,646 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ 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 Shield TX (UK) Ltd. 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 2 other package presentations of this same product, including 6 capsules (73059-0001-06), 60 capsules (73059-0001-60). 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?
Shield TX (UK) Ltd 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.
← 73057-0530-08 · Ulai 73060-0001-01 · Florida →
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.