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Chemet succimer 100 mg Capsule, 100-count — NDC 55292-201-11 (Billing 55292-0201-11)

by Recordati Rare Diseases, Inc. · 100 CAPSULE in 1 BOTTLE

This is a package of 100 capsules of Chemet succimer 100 mg Capsule from Recordati Rare Diseases, Inc., marketed since Aug 2013 and currently FDA-listed. It is this product's only package size.

NDC 55292-0201-11
🏷️ FDA NDC (as labeled) 55292-201-11 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55292-201-11
Product NDC 55292-201
11-digit billing NDC 55292020111
NCPDP billing unit EA — each (per item)
RxCUI 198227, 207949
UNII DX1U2629QE
UPC 0355292201117
Application # NDA019998
SPL Set ID 62035612-9505-3a3f-1ac8-e2dbd711d24e
Established class (EPC) Lead Chelator
Mechanism of action Lead Chelating Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-08-21
Route ORAL
Dosage form CAPSULE
Substance SUCCIMER

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

GPI-14 93100080000120
GPI class Chemet
GCN Seq No 015937
GCN 05001
HICL code 006079
Ingredient (HICL) Succimer
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C8
Therapeutic class — intermediate (HIC2) Antidotes To Poisons
HIC3 code C8A
Therapeutic class — specific (HIC3) Metallic Poison,Agents To Treat
AHFS code 64:00.00.00
AHFS class Heavy Metal Antagonists
FDB label name CHEMET 100 MG CAPSULE
FDB brand name Chemet
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 015937
  • GCN: 05001
  • GPI-14 (Medi-Span): 93100080000120
  • HICL (First Databank): 006079
  • AHFS class code: 64:00.00.00
  • RxCUI (RxNorm): 198227
Why two NDCs? The FDA registers this code as 55292-201-11 — 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 → 55292-0201-11. 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 Lead Chelator class.

Pharmacologic class Lead Chelator
How it works Lead Chelating Activity
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 CHEMET 100 MG CAPSULE Ingredient Succimer
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 $21.72 $2,171.79 / 100 capsules
Medicare drug plans payPart D · Q2 2026 $22.05 $2,204.69 / 100 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 Marketing startMarketing endStatus
55292-0201-11 You're viewing this Main listing 100 CAPSULE in 1 BOTTLE 2013-08-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Chemet 100 mgthis 55292-0201-11 Recordati 100 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

🏛️
2013
On the market since
Aug 2013
📍
2026
Currently FDA-listed
13 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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

Inactive Ingredients / Excipients

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

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

  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 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.

7 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

LabelerRecordati Rare Diseases, Inc.
Application holderRECORDATI RARE DISEASES INC
FDA applicationNDA019998 (NDA)
Labeler code55292
First marketedAug 2013
Product typeHuman Prescription Drug
Portfolio18 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 132 words ▾

1 INDICATIONS AND USAGE CHEMET is indicated for the treatment of lead poisoning in pediatric patients aged 1 year and older with blood lead levels above 45 mcg/dL. CHEMET is a lead chelator indicated for the treatment of lead poisoning in pediatric patients aged 1 year and older with blood lead levels above 45 mcg/dL. ( 1 ) Limitations of Use CHEMET is not indicated for prophylaxis of lead poisoning in a lead-containing environment.

( 1 ) CHEMET does not cross the blood-brain barrier and is not indicated to treat encephalopathy associated with lead toxicity. ( 1 ) Limitations of Use CHEMET is not indicated for prophylaxis of lead poisoning in a lead-containing environment. CHEMET does not cross the blood-brain barrier and is not indicated to treat encephalopathy associated with lead toxicity.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for important pretreatment evaluations. ( 2.1 ) Ensure patients receiving CHEMET are adequately hydrated. ( 2.3 ) Administer CHEMET capsules whole when possible.

( 2.3 ) Pediatric patients who cannot swallow whole capsules: Sprinkle contents of capsule in food (or on a spoon followed by a drink). ( 2.3 ) Recommended Dosage: 10 mg/kg or 350 mg/m 2 orally every 8 hours for five days followed by 10 mg/kg or 350 mg/m 2 orally every 12 hours for an additional 14 days. ( 2.2 )

2.1Important Pretreatment Evaluations Identify the source of lead in the pediatric patient's environment and eliminate the source prior to beginning treatment with CHEMET. Assess the following before initiating treatment with CHEMET: Blood lead concentration Complete blood count (CBC) with differential and platelets [see Dosage and Administration (2.2) , Warnings and Precautions (5.2) ] Ensure absolute neutrophil count (ANC) > 1500/mcL [see Dosage and Administration (2.2) ] Transaminases (AST/ALT) [see Warnings and Precautions (5.3) and Use in Specific Populations (8.6) ] Renal function with blood urea nitrogen (BUN), creatinine, urinary protein [see Use in Specific Populations (8.5) ] .

Patients who have previously received Edetate calcium disodium (CaNa 2 EDTA) with or without dimercaprol may receive CHEMET for subsequent treatment after an interval of four weeks.

2.2Recommended Dosage The recommended dosage of CHEMET for pediatric patients with lead poisoning is 10 mg/kg or 350 mg/m 2 orally every 8 hours for five days followed by 10 mg/kg or 350 mg/m 2 orally every 12 hours for an additional 14 days [see Table 1 CHEMET Pediatric Dosing Chart ]. Initiation of therapy at higher doses is not recommended. The total treatment course consists of 19 days.

After discontinuation of CHEMET, elevated blood levels and associated symptoms may return rapidly because of redistribution of lead from bone stores to soft tissues and blood. Assess blood lead concentration after the completion of a 19 day course and every week until stable. Repeated courses may be administered after two weeks off treatment if blood lead concentrations remain elevated.

A minimum of two weeks between treatment courses is recommended unless blood lead concentrations indicate the need for more prompt treatment. Table 1. CHEMET Pediatric Dosing Chart Weight in Kilograms (kg) Dose (mg) Number of Capsules 8 to15 kg 100 mg 1 16 to 23 kg 200 mg 2 24 to 34 kg 300 mg 3 35 to 44 kg 400 mg 4 >45 kg 500 mg 5 The safety of uninterrupted dosing longer than 3 weeks has not been established and is not recommended.

Dosage Modifications for Neutropenia Monitor CBCs weekly. If the absolute neutrophil count (ANC) is <1200/mcL interrupt CHEMET. Resume CHEMET when ANC has recovered to >1500/mcL (or the patient's baseline count).

Immediately discontinue CHEMET for signs/symptoms of infection. Only rechallenge patients who developed neutropenia with CHEMET therapy if the benefit clearly outweighs the potential risk.

2.3Preparation and Administration Instructions Administer CHEMET capsules whole. In pediatric patients who cannot swallow the capsules whole, separate the capsule and sprinkle the medicated beads on a small amount of soft food or put them in a spoon and follow with a fruit drink. Ensure that all patients receiving CHEMET are adequately hydrated [see Use in Specific Populations (8.5) , Pharmacokinetics (12.3) ] .

💊 Dosage Forms and Strengths 21 words ▾

3 DOSAGE FORMS AND STRENGTHS Capsules: 100 mg, opaque white, imprinted black with "CHEMET 100". Capsule: 100 mg ( 3 )

⛔ Contraindications 43 words ▾

4 CONTRAINDICATIONS CHEMET is contraindicated in patients with a history of hypersensitivity reaction to succimer. Reactions have included mucocutaneous vesicular eruptions, urticaria, and angioedema [see Warnings and Precautions (5.1) ] . Patients with a history of hypersensitivity reaction to succimer. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity and dermatologic reactions: Interrupt treatment if rash or mucocutaneous vesicular eruptions occur. ( 5.1 ) Neutropenia: Monitor complete blood counts, interrupt treatment for ANC below 1200/mcL, and monitor for infection. ( 5.2 ) Hepatic Toxicity: Monitor hepatic transaminases (ALT/AST); interrupt treatment if above 5 times ULN.

( 5.3 ) Embryo-Fetal Toxicity: May cause fetal harm when administered to a pregnant woman. ( 5.5 )

5.1Hypersensitivity and Dermatologic Reactions CHEMET can cause hypersensitivity reactions and dermatologic reactions. Rash Rash occurs in approximately 4% of patients treated with CHEMET. Interrupt treatment if rash occurs.

Consider rechallenge if lead levels are high enough to warrant retreatment. Hypersensitivity reactions including urticaria and angioedema have been reported on repeated administration of CHEMET [see Contraindications (4) ]. Mucocutaneous Reactions Mucocutaneous vesicular eruptions can occur with CHEMET use and may increase with each treatment course.

Monitor patients requiring repeated CHEMET courses for the occurrence of mucocutaneous eruptions, including oral, urethral, and perianal. Interrupt treatment if mucocutaneous vesicular eruptions occur.

5.2Neutropenia Iron chelators, including CHEMET, can cause neutropenia. Monitoring of complete blood counts is recommended [see Dosage and Administration (2.2) ] . Interrupt treatment if absolute neutrophil count (ANC) is <1200/mcL and interrupt treatment until recovery to above 1500/mcL (or the patient's baseline count).

Only rechallenge patients who developed neutropenia with CHEMET therapy if the benefit clearly outweighs the potential risk. If rechallenge is attempted, monitor CBC more frequently. Monitor for signs and symptoms of infection and immediately discontinue CHEMET if they develop.

5.3Hepatic Toxicity Elevated transaminases (ALT/AST) occurred in 6-10% of patients treated with CHEMET. Monitor serum AST and ALT at baseline and at least weekly during treatment. Monitor patients with a history of liver disease more frequently. Serum aminotransferase elevations above 5 times the upper limit of normal (if confirmed) should lead to dose reduction or temporary cessation.

5.4Embryo-Fetal Toxicity Based on findings from animal reproduction studies, CHEMET may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use an effective method of contraception during treatment with CHEMET and for 14 days after the final dose [see Use in Specific Populations (8.1 , 8.3) ] .

5.5Laboratory Test Interference CHEMET may interfere with serum and urinary laboratory tests [see Drug Interactions (7.1) ] .

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity and Dermatologic Reactions [see Warnings and Precautions (5.1) ] Neutropenia [see Warnings and Precautions (5.2) ] Hepatic Toxicity [see Warnings and Precautions (5.3) ] Most common adverse reactions (incidence ≥ 10%) in Pediatric patients: Digestive (nausea, vomiting, diarrhea, appetite loss, hemorrhoidal symptoms, metallic taste in mouth). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344 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. Table 2 presents the adverse reactions associated with Chemet in pediatric patients. Table 2 Incidence of Adverse Reactions Associated with Chemet in Pediatric Patients Body System: Adverse Reactions Pediatric Patients (n=191) Digestive Nausea, vomiting, diarrhea, appetite loss, hemorrhoidal symptoms, metallic taste in mouth 12% Body as a Whole Back pain, abdominal cramps, stomach pains, head pain, rib pain, chills, flank pain, fever, flu-like symptoms, heavy head/tired, head cold, headache, moniliasis.

5% Metabolic Elevated ALT or AST, alkaline phosphatase, serum cholesterol. 4% Respiratory Sore throat, rhinorrhea, nasal congestion, cough. 4% Skin Papular rash, herpetic rash, rash, mucocutaneous eruptions, pruritis.

3% Nervous Drowsiness, dizziness, sensorimotor neuropathy, sleepiness, paresthesia. 1% Special Senses Cloudy film in eye, ears plugged, otitis media, eyes watery. 1% Heme/Lymphatic Neutropenia, increased platelet count, eosinophilia 1%

🔄 Drug Interactions 80 words ▾

7 DRUG INTERACTIONS CHEMET may interfere with serum and urinary laboratory test. ( 7.1 )

7.1Laboratory Test Interference CHEMET may interfere with serum and urinary laboratory tests. In vitro studies have shown CHEMET to cause false positive results for ketones in urine using nitroprusside reagents and falsely decreased measurements of serum uric acid and creatinine phosphokinase (CPK).

7.2Use with Other Chelation Therapies Concomitant administration of CHEMET with other chelation therapy, such as CaNa 2 EDTA is not recommended.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm. ( 8.1 ) Renal Impairment: Assess renal function. ( 8.6 ) Hepatic Impairment: Assess hepatic function. (8.7)

8.1Pregnancy Risk Summary There are no studies with the use of CHEMET in pregnant women to inform drug-associated risks. Administration of CHEMET to pregnant mice during organogenesis at dose exposure of 11-times the human exposure at the maximum recommended human dose (MRHD) of 700 mg based on body surface area (BSA) resulted in maternal toxicity and mortality and impaired reflex development in offspring (see Animal Data ) . There are adverse effects on maternal and fetal outcomes associated with lead poisoning in pregnancy (see Clinical Considerations ) .

CHEMET should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

However, the background risk in the U.S general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Lead exposure in pregnancy may increase the risk of gestational hypertension. Lead crosses the placenta in amounts related to maternal plasma levels.

Prenatal lead exposure may be associated with spontaneous abortion, preterm delivery, decreased birth weight, and impaired neurodevelopment. Data Animal Data In embryo-fetal developmental studies, pregnant mice received subcutaneous succimer during the period of organogenesis at doses up to 1640 mg/kg/day (11-times the MRHD based on BSA) which resulted in both maternal and fetal toxicity. In a developmental study in rats, dosing with succimer during the period of organogenesis resulted in maternal toxicity and deaths at the dose of 720 mg/kg/day (10-times the MRHD based on BSA) or more.

The dose of 510 mg/kg/day (7-times the MRHD based on BSA) was the highest tolerable dose in pregnant rats. Impaired development of reflexes was noted in pups of dams receiving 720 mg/kg/day (10-times the MRHD based on BSA).

8.2Lactation Risk Summary There are no data on the presence of succimer or its metabolite in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. There are clinical considerations regarding lead in breastmilk (see Clinical Considerations ) . Clinical Considerations When used for the treatment of lead poisoning, the amount of lead in breast milk may range from 0.6% to 3% of the maternal serum concentration.

Females with confirmed blood lead levels ≥40 mcg/dL should not initiate breastfeeding; pumping and discarding breast milk is recommended until blood lead levels are <40 mcg/dL, at which point breastfeeding may resume. Calcium supplementation may reduce the amount of lead in breast milk.

8.3Females and Males of Reproductive Potential CHEMET may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Pregnancy Testing Pregnancy testing is recommended for females of reproductive potential prior to treatment with CHEMET. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with CHEMET and for 14 days after the final dose.

8.4Pediatric Use The safety and effectiveness of CHEMET for the treatment of lead poisoning in patients with blood levels above 45 mcg/mL have been established in pediatric patients aged 1 year and older. The safety and effectiveness of CHEMET have not been established in pediatric patients younger than 1 year of age.

8.5Renal Impairment Assess renal function prior to and periodically during prolonged therapy. Adequately hydrate patients during therapy. Limited data suggests that succimer is dialyzable, but the lead chelates are not. Monitor patien… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are no studies with the use of CHEMET in pregnant women to inform drug-associated risks. Administration of CHEMET to pregnant mice during organogenesis at dose exposure of 11-times the human exposure at the maximum recommended human dose (MRHD) of 700 mg based on body surface area (BSA) resulted in maternal toxicity and mortality and impaired reflex development in offspring (see Animal Data ) . There are adverse effects on maternal and fetal outcomes associated with lead poisoning in pregnancy (see Clinical Considerations ) .

CHEMET should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

However, the background risk in the U.S general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Lead exposure in pregnancy may increase the risk of gestational hypertension. Lead crosses the placenta in amounts related to maternal plasma levels.

Prenatal lead exposure may be associated with spontaneous abortion, preterm delivery, decreased birth weight, and impaired neurodevelopment. Data Animal Data In embryo-fetal developmental studies, pregnant mice received subcutaneous succimer during the period of organogenesis at doses up to 1640 mg/kg/day (11-times the MRHD based on BSA) which resulted in both maternal and fetal toxicity. In a developmental study in rats, dosing with succimer during the period of organogenesis resulted in maternal toxicity and deaths at the dose of 720 mg/kg/day (10-times the MRHD based on BSA) or more.

The dose of 510 mg/kg/day (7-times the MRHD based on BSA) was the highest tolerable dose in pregnant rats. Impaired development of reflexes was noted in pups of dams receiving 720 mg/kg/day (10-times the MRHD based on BSA).

🧒 Pediatric Use 53 words ▾

8.4Pediatric Use The safety and effectiveness of CHEMET for the treatment of lead poisoning in patients with blood levels above 45 mcg/mL have been established in pediatric patients aged 1 year and older. The safety and effectiveness of CHEMET have not been established in pediatric patients younger than 1 year of age.

🆘 Overdosage 56 words ▾

10 OVERDOSAGE Doses of 2300 mg/kg in the rat and 2400 mg/kg in the mouse produced ataxia, convulsions, labored respiration and frequently death. Limited data indicate that CHEMET is dialyzable. In case of acute overdosage, consider use of induction of vomiting or gastric lavage followed by administration of an activated charcoal slurry and appropriate supportive therapy.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Succimer is a lead chelator; it forms water soluble chelates and, consequently, increases the urinary excretion of lead.

12.2Pharmacodynamics Effect on Essential Minerals In dose ranging studies performed in 18 men with blood lead levels of 44-96 mcg/dL, three groups of 6 patients received either 10, 6.7 or 3.3 mg/kg succimer orally every 8 hours for 5 days. After five days the mean blood lead levels of the three groups decreased 72.5%, 58.3% and 35.5% respectively. The mean urinary lead excretions in the initial 24 hours were 28.6, 18.6 and 12.3 times the pretreatment 24 hour urinary lead excretion.

CHEMET had no significant effect on the urinary elimination of iron, calcium or magnesium. Zinc excretion doubled during treatment.

12.3Pharmacokinetics Absorption Succimer achieved peak plasma concentrations at 1–2 hours. Elimination Metabolism Approximately 90% of absorbed dose is metabolized to mixed succimer-cysteine disulfides. The majority of mixed disulfides consisted of succimer in disulfide linkages with two molecules of L-cysteine, the remaining disulfides contained one L-cysteine per succimer molecule.

Excretion In a study performed in healthy adult volunteers, after a single dose of 14C-succimer at 16, 32, or 48 mg/kg, 49% of the radiolabeled dose was excreted on average: 39% in the feces, 9% in the urine and 1% as carbon dioxide from the lungs. The apparent elimination half-life of the radiolabeled material in the blood was about two days. In other studies of healthy adult volunteers receiving a single oral dose of 10 mg/kg, approximately 25% of the administered dose was excreted in the urine with the peak blood level and urinary excretion occurring between two and four hours.

Of the total amount of drug eliminated in the urine, approximately 90% was eliminated in altered form as mixed succimer-cysteine disulfides; the remaining 10% was eliminated unchanged.

🧬 Mechanism of Action 22 words ▾

12.1Mechanism of Action Succimer is a lead chelator; it forms water soluble chelates and, consequently, increases the urinary excretion of lead.

📦 How Supplied / Storage and Handling 37 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Capsules: 100 mg of CHEMET (succimer), imprinted black with "CHEMET 100", in a bottle of 100 (NDC 55292-201-11). Store between 15°C and 25°C and avoid excessive heat. Dispense in tight, light-resistant container.

📦 Storage and Handling 14 words ▾

Store between 15°C and 25°C and avoid excessive heat. Dispense in tight, light-resistant container.

📋 Description 115 words ▾

11 DESCRIPTION CHEMET (succimer) is an orally active, lead chelating agent. The chemical name for succimer is meso 2, 3-dimercaptosuccinic acid (DMSA). Its empirical formula is C 4 H 6 O 4 S 2 and molecular weight is 182.2.

The meso -structural formula is: Succimer is a white crystalline powder with an unpleasant, characteristic mercaptan odor and taste. Each CHEMET opaque white capsule for oral administration contains medicated beads with 100 mg of succimer and the following inactive ingredients: povidone, sodium starch glycolate, and sugar spheres. The capsule shell contains benzyl alcohol, butylparaben, edetate calcium disodium, gelatin, methylparaben, propylparaben, sodium lauryl sulfate, sodium propionate, titanium dioxide, and is imprinted with edible black ink.

Chemical Structure

💬 Information for Patients 107 words ▾

17 PATIENT COUNSELING INFORMATION Advise caregivers and/or patients to maintain adequate fluid intake [see Dosage and Administration (2.3) ]. Advise caregivers and/or patients to contact their healthcare provider should a rash develop [see Warnings and Precautions (5.1) ] . Advise caregivers and/or patients to contact their healthcare provider right away if signs/symptoms of infection develop [see Warnings and Precautions (5.2) ] .

Advise caregivers that in pediatric patients who cannot swallow the capsules whole, separate the capsule and sprinkle the medicated beads on a small amount of soft food or put them in a spoon and follow with a fruit drink [see Dosage and Administration (2.3) ].

🧬 Pharmacokinetics 177 words ▾

12.3Pharmacokinetics Absorption Succimer achieved peak plasma concentrations at 1–2 hours. Elimination Metabolism Approximately 90% of absorbed dose is metabolized to mixed succimer-cysteine disulfides. The majority of mixed disulfides consisted of succimer in disulfide linkages with two molecules of L-cysteine, the remaining disulfides contained one L-cysteine per succimer molecule.

Excretion In a study performed in healthy adult volunteers, after a single dose of 14C-succimer at 16, 32, or 48 mg/kg, 49% of the radiolabeled dose was excreted on average: 39% in the feces, 9% in the urine and 1% as carbon dioxide from the lungs. The apparent elimination half-life of the radiolabeled material in the blood was about two days. In other studies of healthy adult volunteers receiving a single oral dose of 10 mg/kg, approximately 25% of the administered dose was excreted in the urine with the peak blood level and urinary excretion occurring between two and four hours.

Of the total amount of drug eliminated in the urine, approximately 90% was eliminated in altered form as mixed succimer-cysteine disulfides; the remaining 10% was eliminated unchanged.

🧬 Pharmacodynamics 101 words ▾

12.2Pharmacodynamics Effect on Essential Minerals In dose ranging studies performed in 18 men with blood lead levels of 44-96 mcg/dL, three groups of 6 patients received either 10, 6.7 or 3.3 mg/kg succimer orally every 8 hours for 5 days. After five days the mean blood lead levels of the three groups decreased 72.5%, 58.3% and 35.5% respectively. The mean urinary lead excretions in the initial 24 hours were 28.6, 18.6 and 12.3 times the pretreatment 24 hour urinary lead excretion.

CHEMET had no significant effect on the urinary elimination of iron, calcium or magnesium. Zinc excretion doubled during treatment.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES The efficacy of CHEMET in the treatment of lead poisoning in pediatric patients was established in a dose-ranging, actively controlled study of 15 pediatric patients aged 2 to 7 years with blood lead levels of 30-49 mcg/dL and positive CaNa 2 EDTA lead mobilization tests. Fifteen patients were assigned to a dose of 350 mg/m 2 or 233 mg/m 2 , or 116 mg/m 2 (5 patients per group) orally every 8 hours for 5 days. Six control patients received 1000 mg/m 2 /day CaNa 2 EDTA intravenously for 5 days.

Following therapy, the mean blood lead levels decreased 78, 63, and 42% respectively in the three CHEMET treatment groups. The response of the 350 mg/m 2 every 8 hours (10 mg/kg every 8 hours) group was significantly better than that of the other CHEMET dose level groups as well as that of the control group, whose mean blood lead level fell 48%. Although other dosing regimens were used in the study described, only 10 mg/kg or 350 mg/m 2 orally every 8 hours for five days followed by 10 mg/kg or 350 mg/m 2 orally every 12 hours for an additional 14 days is the recommended dosage.

Patients experienced a rebound in blood lead levels after discontinuation of CHEMET. In these studies, after treatment with a dose of 350 mg/m 2 (10 mg/kg) every 8 hours for five days, the mean lead level rebounded and plateaued at 60-85% of pretreatment levels two weeks after therapy. In an attempt to control rebound of blood lead levels, 19 pediatric patients, ages 1 to 7 years, with blood lead levels of 42-67 mcg/dL, were treated with 350 mg/m 2 CHEMET every 8 hours for five days and then divided into three groups.

One group was followed for two weeks with no further therapy, the second group was treated for two weeks with 350 mg/m 2 daily, and the third with 350 mg/m 2 every 12 hours. After the initial 5 days of therapy, the mean blood lead level in all subjects declined 61%. While the untreated group and the group treated with 350 mg/m 2 daily experienced rebound during the ensuing two weeks, the group who received the 350 mg/m 2 every 12 hours experienced no such rebound during the treatment period and less rebound following cessation of therapy.

In another study, ten pediatric patients, ages 21 to 72 months, with blood lead levels of 30-57 mcg/dL were treated with CHEMET 350 mg/m 2 every eight hours for five days followed by an additional 19-22 days of therapy at a dose of 350 mg/m 2 every 12 hours. The mean blood lead levels decreased and remained stable at under 15 mcg/dL during the extended dosing period. In addition to the controlled studies, approximately 250 patients with lead poisoning have been treated with CHEMET either orally or parenterally in open U.S. and foreign studies.

🧪 Nonclinical Toxicology 73 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity studies have been conducted with CHEMET. Succimer was not mutagenic in the Ames bacterial reverse mutation assay and in the mammalian cell forward gene mutation assay. Succimer did not show any adverse effects on fertility and reproductive performance in rats up to doses of 510 mg/kg/day in males and 100 mg/kg/day in females (7- and 11-times the MRHD based on BSA, respectively).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 70 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity studies have been conducted with CHEMET. Succimer was not mutagenic in the Ames bacterial reverse mutation assay and in the mammalian cell forward gene mutation assay. Succimer did not show any adverse effects on fertility and reproductive performance in rats up to doses of 510 mg/kg/day in males and 100 mg/kg/day in females (7- and 11-times the MRHD based on BSA, respectively).

📄 Package Label / Principal Display Panel 34 words ▾

PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Label NDC 55292-201-11 100 Capsules Chemet ® (succimer) Capsules 100 mg RECORDATI RARE DISEASES GROUP Rx only PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Label

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
65
Units reimbursed last 4 qtrs
4.6K
Gross reimbursed last 4 qtrs
$99.8K
Avg / prescription
$1,534.95
Avg / unit
$21.7179
Latest quarter Q1 2026
0Rx
Fee-for-service vs managed care ⓘ
42% FFS 58% MCO
Fee-for-service · 27 Rx Managed care · 38 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 1,642 units · 8.4 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 792 units · 6.1 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 1,000 units · 14.3 per 100k residents MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: 1,160 units · 106 per 100k residents RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
6.1106
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Rhode Island 106 /100k
2 Massachusetts 14.3 /100k
3 New York 8.4 /100k
4 Pennsylvania 6.1 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Chemet — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Chemet. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$48.2K
Claims incl. refills
24
Beneficiaries
12
Spend / beneficiary
$4,013.55
Spend / claim
$2,006.77
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Recordati Rare Diseases, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Recordati Rare Diseases, 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.
← 55292-0143-01 · Recordati 55292-0320-20 · Recordati →
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.