Chemet

Manufacturer
Recordati Rare Diseases, Inc. | Lannett Company, Inc.
Effective date
2025-07-10
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-05-31 21:37:27

Label at a glance#

ProductChemet
Active ingredientSUCCIMER
Label structure17 sections

Indications and uses

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. 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

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...

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.

Label contents#

Full prescribing information#

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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.

SPL UNCLASSIFIED SECTION

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.

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

2.1 Important Pretreatment Evaluations

SPL UNCLASSIFIED SECTION

2.3 Preparation and Administration Instructions

SPL UNCLASSIFIED SECTION

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)] .

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Capsules: 100 mg, opaque white, imprinted black with "CHEMET 100".

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

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)] .

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

5.1 Hypersensitivity and Dermatologic Reactions

SPL UNCLASSIFIED SECTION

CHEMET can cause hypersensitivity reactions and dermatologic reactions.

SPL UNCLASSIFIED SECTION

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)].

SPL UNCLASSIFIED SECTION

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.

5.2 Neutropenia

SPL UNCLASSIFIED SECTION

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.

5.3 Hepatic Toxicity

SPL UNCLASSIFIED SECTION

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.

5.4 Embryo-Fetal Toxicity

SPL UNCLASSIFIED SECTION

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)] .

5.5 Laboratory Test Interference

SPL UNCLASSIFIED SECTION

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

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

The following clinically significant adverse reactions are described elsewhere in the labeling:

6.1 Clinical Trials Experience

CLINICAL TRIALS EXPERIENCE SECTION

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 ReactionsPediatric Patients
(n=191)
Digestive * 12%
Body as a Whole † 5%
Metabolic ‡ 4%
Respiratory § 4%
Skin 3%
Nervous # 1%
Special Senses ♠ 1%
Heme/Lymphatic ♥ 1%

* Nausea, vomiting, diarrhea, appetite loss, hemorrhoidal symptoms, metallic taste in mouth

† Back pain, abdominal cramps, stomach pains, head pain, rib pain, chills, flank pain, fever, flu-like symptoms, heavy head/tired, head cold, headache, moniliasis.

‡ Elevated ALT or AST, alkaline phosphatase, serum cholesterol.

§ Sore throat, rhinorrhea, nasal congestion, cough.

Papular rash, herpetic rash, rash, mucocutaneous eruptions, pruritis.

# Drowsiness, dizziness, sensorimotor neuropathy, sleepiness, paresthesia.

♠ Cloudy film in eye, ears plugged, otitis media, eyes watery.

♥ Neutropenia, increased platelet count, eosinophilia

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

7.1 Laboratory Test Interference

SPL UNCLASSIFIED SECTION

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).

7.2 Use with Other Chelation Therapies

SPL UNCLASSIFIED SECTION

Concomitant administration of CHEMET with other chelation therapy, such as CaNa 2EDTA is not recommended.

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

8.1 Pregnancy

PREGNANCY SECTION

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

Clinical Considerations

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

Data

SPL UNCLASSIFIED SECTION

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).

8.2 Lactation

LACTATION SECTION

SPL UNCLASSIFIED SECTION

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) .

SPL UNCLASSIFIED SECTION

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.

8.3 Females and Males of Reproductive Potential

FEMALES & MALES OF REPRODUCTIVE POTENTIAL SECTION

CHEMET may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)] .

SPL UNCLASSIFIED SECTION

Pregnancy Testing

Pregnancy testing is recommended for females of reproductive potential prior to treatment with CHEMET.

SPL UNCLASSIFIED SECTION

Contraception

SPL UNCLASSIFIED SECTION

Females

Advise females of reproductive potential to use effective contraception during treatment with CHEMET and for 14 days after the final dose.

8.4 Pediatric Use

PEDIATRIC USE SECTION

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.

8.5 Renal Impairment

RENAL IMPAIRMENT SUBSECTION

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 patients with a history of renal impairment more frequently.

8.6 Hepatic Impairment

HEPATIC IMPAIRMENT SUBSECTION

Assess hepatic function prior to and periodically during therapy. Monitor patients with a history of liver disease more frequently [see Warnings and Precautions (5.3)] .

10 OVERDOSAGE

OVERDOSAGE SECTION

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.

11 DESCRIPTION

DESCRIPTION SECTION

CHEMET (succimer) is an orally active, lead chelating agent. The chemical name for succimer is meso2, 3-dimercaptosuccinic acid (DMSA). Its empirical formula is C 4H 6O 4S 2and molecular weight is 182.2. The meso-structural formula is:

Chemical StructureChemical Structure

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.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

12.1 Mechanism of Action

MECHANISM OF ACTION SECTION

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

12.2 Pharmacodynamics

PHARMACODYNAMICS SECTION

SPL UNCLASSIFIED SECTION

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.

12.3 Pharmacokinetics

PHARMACOKINETICS SECTION

SPL UNCLASSIFIED SECTION

Absorption

Succimer achieved peak plasma concentrations at 1–2 hours.

SPL UNCLASSIFIED SECTION

Elimination

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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.

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

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).

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

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 2EDTA lead mobilization tests. Fifteen patients were assigned to a dose of 350 mg/m 2or 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 2EDTA 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 2every 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 2orally every 8 hours for five days followed by 10 mg/kg or 350 mg/m 2orally 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 2CHEMET 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 2daily, and the third with 350 mg/m 2every 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 2daily experienced rebound during the ensuing two weeks, the group who received the 350 mg/m 2every 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 2every eight hours for five days followed by an additional 19-22 days of therapy at a dose of 350 mg/m 2every 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.

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

Capsules: 100 mg of CHEMET (succimer), imprinted black with "CHEMET 100", in a bottle of 100 (NDC 55292-201-11).

STORAGE AND HANDLING SECTION

Store between 15°C and 25°C and avoid excessive heat.

Dispense in tight, light-resistant container.

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

  • 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)].

SPL UNCLASSIFIED SECTION

Manufactured for:
Recordati Rare Diseases Inc.
Bridgewater, NJ 08807

PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
207949Chemet 100 MG Oral CapsulePSN10
198227succimer 100 MG Oral CapsulePSN10
207949succimer 100 MG Oral Capsule [Chemet]SBD10
198227succimer 100 MG Oral CapsuleSCD10
207949Chemet 100 MG Oral CapsuleSY10

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
SUCCIMER Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2f5edee6-054b-4e78-9516-4902240bd895Product name120221206
67641ec0-7553-6d3f-05ca-04c54d959119Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55292-201-11Chemet100 in 1 BOTTLECAPSULE10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55292-201-11EA - Each55292-2017cda149d-bca1-4c4d-bb86-f88d3e3cf42912013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SUCCIMERACTIVE INGREDIENTDX1U2629QE1
SUCCIMERACTIVE MOIETYDX1U2629QE1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
GELATININACTIVE INGREDIENT2G86QN327L1
POVIDONESINACTIVE INGREDIENTFZ989GH94E1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A21
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1
SUCROSEINACTIVE INGREDIENTC151H8M5541
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55292-20155292-201-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POVIDONESPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE / ORAL3568 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE / ORAL3568 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE / ORAL5785 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE / ORAL5785 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE / ORAL5 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE / ORAL5 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019998-002CHEMETSUCCIMER100MGCAPSULE / ORALRLD, RS1991-01-30

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-302680178bc6a6…
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2024-10-29 15:01 UTC2024-10N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30d06236e962d9…
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2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-305d02ea3f76ae…
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2021-03-12 10:30 UTC2021-03N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-303f01610625f2…
2019-09-15 20:21 UTC2019-09N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30b00525d2431f…
2019-07-19 19:46 UTC2019-07N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-303f0d92c62455…
2023-05-13 08:27 UTC2023-05N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30053a50430f4f…
2023-01-26 05:58 UTC2023-01N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChemetSUCCIMERRecordati Rare Diseases, Inc.62035612-9505-3a3f-1ac8-e2dbd711d24e2025-07-10Warnings, Adverse reactionsExact identifier
ndc (package): 55292-201-11
ndc (product): 55292-201
ndc11 (package): 55292020111
spl id: 399a2f13-1fa5-5557-e063-6294a90a48a2
spl set id: 62035612-9505-3a3f-1ac8-e2dbd711d24e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.