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ETHOSUXIMIDE 250 mg Capsule, 100-count — NDC 64380-0878-06 package photo

ETHOSUXIMIDE 250 mg Capsule, 100-count

by Strides Pharma Science Limited · 100 CAPSULE in 1 BOTTLE (64380-878-06)
NDC 64380-0878-06
🏷️ FDA NDC (as labeled) 64380-878-06 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 64380-878-06
Product NDC 64380-878
11-digit billing NDC 64380087806
NCPDP billing unit EA — each (per item)
RxCUI 197682
UNII 5SEH9X1D1D
UPC 0364380878063
Application # ANDA211928
SPL Set ID a4dbc665-4db1-4d0a-9630-5cd200ec4c82
Established class (EPC) Anti-epileptic Agent
Physiologic effect Decreased Central Nervous System Disorganized Electrical Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-05-15
Route ORAL
Dosage form CAPSULE
Substance ETHOSUXIMIDE
GPI-14 72400010000105
GCN Seq No 004554
GCN 17420
HICL code 001891
Ingredient (HICL) Ethosuximide
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H4
Therapeutic class — intermediate (HIC2) Anticonvulsants
HIC3 code H4B
Therapeutic class — specific (HIC3) Anticonvulsants
AHFS code 28:12.20.00
AHFS class Succinimides
FDB label name ETHOSUXIMIDE 250 MG CAPSULE
FDB brand name Ethosuximide
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 64380-878-06 — 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 → 64380-0878-06. 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 Anti-epileptic Agent class.

Pharmacologic class Anti-epileptic Agent
Drug family (ATC) Succinimide derivatives
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.

🏭 Manufacturer & labeler

LabelerStrides Pharma Science Limited
Application holderONESOURCE SOFTGELS PTE LTD
FDA applicationANDA211928 (ANDA)
Labeler code64380
First marketedMay 2019
Product typeHuman Prescription Drug
Portfolio195 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.

🩺 Clinical

Label name ETHOSUXIMIDE 250 MG CAPSULE Ingredient Ethosuximide
📖 What it is MedlinePlus · NLM

Ethosuximide is used to control absence seizures (petit mal) (a type of seizure in which there is a very short loss of awareness during which the person may stare straight ahead or blink his eyes and does not respond to others). Ethosuximide is in a class of medications called anticonvulsants. It works by reducing abnormal electrical activity in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • An absence seizure is a brief episode — usually just a few seconds — where you or your child suddenly stares blankly and loses awareness, then snaps back as if nothing happened. Th...
  • What exactly is an absence seizure, and will ethosuximide stop them?
  • Ethosuximide comes as a capsule or a liquid solution, and you take it by mouth. Your doctor will start you on a lower dose and gradually increase it until your seizures are well co...
  • How do I take it, and does it matter if I take it with food?
📖 Read our full Ethosuximide guide →
1
Nutrient depletion considerations

Ethosuximide may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

💊 What it looks like

Color orange
ShapeCapsule
Imprint250
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 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII PN2ZH5LOQY
    A synthetic red dye approved by the FDA for use in foods, medicines, and cosmetics. It serves as a colorant to make tablets, capsules, and liquids visually distinctive for product identification.
  • 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 PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII 9E0S3UM200
    A sugar alcohol solution derived from glucose that stays liquid without forming crystals. It functions as a sweetener, humectant (moisture-retaining agent), and solvent in liquid medications and syrups.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • 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.

13 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 DailyMedingredient 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.

💲 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 eaPer package
Retail pharmacies payNADAC · weekly $0.248 $24.83 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $0.3657 $36.57 / 100 capsules
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Aug 2022 Jan 2026 Aug 2026 $0.610 $0.240
▼ Down 14% over the last 22 months.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ethosuximide 250 mg 42806-0708-01 Epic 100 capsules $0.248 AB Availability likely
Ethosuximide 250 mg 42806-0711-01 Epic 100 capsules $0.248 AB Availability likely
Ethosuximide 250 mg 62135-0790-12 Chartwell 120 capsules $0.248 Availability likely
Ethosuximide 250 mgthis 64380-0878-06 Strides 100 capsules $0.248 AB Availability likely
Ethosuximide 250 mg 69452-0152-20 Bionpharma 100 capsules $0.248 AB Availability likely
Zarontin 250 mg 00071-0237-24 Parke-Davis 100 capsules $1.309 AB Availability likely +427%
Ethosuximide 250 mg 63629-8005-01 Bryant 90 capsules AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2019
On the market since
May 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

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

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

🗺️ 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 64380-0878-06, 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 – Q4 2025 · 4 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
6K
Units reimbursed last 4 qtrs
703.7K
Gross reimbursed last 4 qtrs
$257.3K
Avg / prescription
$42.86
Avg / unit
$0.3657
Latest quarter Q4 2025
1.3KRx
Medicaid pays / ea
$0.3657
gross reimbursed
vs
NADAC / ea
$0.2483
acquisition cost
=
Spread
+$0.1174
+47% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
45% FFS 55% MCO
Fee-for-service · 2,723 Rx Managed care · 3,281 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 27,789 units · 356 per 100k residents WA Idaho: 8,564 units · 436 per 100k residents ID Montana: 1,380 units · 122 per 100k residents MT North Dakota: 2,730 units · 349 per 100k residents ND Minnesota: 19,366 units · 338 per 100k residents MN Wisconsin: 24,810 units · 420 per 100k residents WI Michigan: 41,059 units · 409 per 100k residents MI New York: 51,378 units · 263 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 6,532 units · 154 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 5,292 units · 576 per 100k residents SD Iowa: 22,078 units · 688 per 100k residents IA Illinois: 16,791 units · 134 per 100k residents IL Indiana: 16,620 units · 242 per 100k residents IN Ohio: 38,994 units · 331 per 100k residents OH Pennsylvania: 42,726 units · 330 per 100k residents PA New Jersey: 5,316 units · 57.2 per 100k residents NJ Massachusetts: 8,553 units · 122 per 100k residents MA California: 43,608 units · 112 per 100k residents CA Utah: 7,910 units · 231 per 100k residents UT Colorado: 9,768 units · 166 per 100k residents CO Nebraska: 1,230 units · 62.2 per 100k residents NE Missouri: 21,997 units · 355 per 100k residents MO Kentucky: 22,182 units · 490 per 100k residents KY West Virginia: 11,286 units · 638 per 100k residents WV Virginia: 6,732 units · 77.2 per 100k residents VA Maryland: 8,706 units · 141 per 100k residents MD Connecticut: 8,400 units · 232 per 100k residents CT Rhode Island: no data reported RI Arizona: 10,084 units · 136 per 100k residents AZ New Mexico: 1,460 units · 69.1 per 100k residents NM Kansas: 9,632 units · 328 per 100k residents KS Arkansas: 13,587 units · 443 per 100k residents AR Tennessee: 21,250 units · 298 per 100k residents TN North Carolina: 34,556 units · 319 per 100k residents NC South Carolina: 2,670 units · 49.7 per 100k residents SC Delaware: no data reported DE Oklahoma: 12,436 units · 307 per 100k residents OK Louisiana: 9,685 units · 212 per 100k residents LA Mississippi: 2,340 units · 79.6 per 100k residents MS Alabama: 11,479 units · 225 per 100k residents AL Georgia: 29,204 units · 265 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 33,426 units · 110 per 100k residents TX Florida: 12,020 units · 53.2 per 100k residents FL
Units reimbursed · per 100k residents
49.7688
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 Iowa 688 /100k
2 West Virginia 638 /100k
3 South Dakota 576 /100k
4 Kentucky 490 /100k
5 Arkansas 443 /100k
6 Idaho 436 /100k
7 Wisconsin 420 /100k
8 Michigan 409 /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 Ethosuximide — the program that covers self-administered drugs. 6 manufacturers.
⚠️ 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 Ethosuximide. 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
$408.9K
Claims incl. refills
3.9K
Beneficiaries
1.9K
Spend / beneficiary
$215.88
Spend / claim
$105.30
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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Ethosuximide — the ingredient across all brands.

Top reported reactions

Seizure367
Somnolence157
Generalised Tonic-clonic Seizure149
Petit Mal Epilepsy118
Drug Interaction116
Treatment Failure116
Fatigue112

Reporter sex

2,490 reports

Serious outcomes

Death63
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 251 74
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
64380-0878-06 You're viewing this 100 CAPSULE in 1 BOTTLE (64380-878-06) 2019-05-15 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 15 words

INDICATIONS AND USAGE Ethosuximide capsule is indicated for the control of absence (petit mal) epilepsy.

⏱️ Dosage and Administration 173 words

DOSAGE AND ADMINISTRATION Ethosuximide capsules are administered by the oral route. The initial dose for patients 3 to 6 years of age is one capsule (250 mg) per day; for patients 6 years of age and older, 2 capsules (500 mg) per day. The dose thereafter must be individualized according to the patient's response.

Dosage should be increased by small increments. One useful method is to increase the daily dose by 250 mg every four to seven days until control is achieved with minimal side effects. Dosages exceeding 1.5 g daily, in divided doses, should be administered only under the strictest supervision of the physician.

The optimal dose for most pediatric patients is 20 mg/kg/day. This dose has given average plasma levels within the accepted therapeutic range of 40 to 100 mcg/mL. Subsequent dose schedules can be based on effectiveness and plasma level determinations.

Ethosuximide may be administered in combination with other anticonvulsants when other forms of epilepsy coexist with absence (petit mal). The optimal dose for most pediatric patients is 20 mg/kg/day.

Contraindications 15 words

CONTRAINDICATION Ethosuximide should not be used in patients with a history of hypersensitivity to succinimides.

⚠️ Warnings ~3 min read

WARNINGS Blood Dyscrasias: Blood dyscrasias, including some with fatal outcome, have been reported to be associated with the use of ethosuximide; therefore, periodic blood counts should be performed. Should signs and/or symptoms of infection (e.g., sore throat, fever) develop, blood counts should be considered at that point. Drug-Induced Immune Thrombocytopenia: Drug-induced immune thrombocytopenia (DITP) has been reported with ethosuximide.

In the reported cases, the onset of symptoms occurred 1 to 3 weeks after initiation of ethosuximide; one patient had recurrence of symptoms within 1 day of a subsequent re-challenge with the drug. In those cases in which the platelet count was specified, the nadir was 2,000 and 3,000/mm 3 . When DITP is suspected, discontinue ethosuximide, monitor serial platelet counts, and treat as appropriate.

If possible, assess the presence of drug-dependent antiplatelet antibodies. Avoid future use of ethosuximide in patients with history of ethosuximide induced DITP. Effects on Liver and Kidneys: Ethosuximide is capable of producing morphological and functional changes in the animal liver.

In humans, abnormal liver and renal function studies have been reported. Ethosuximide should be administered with extreme caution to patients with known liver or renal disease. Periodic urinalysis and liver function studies are advised for all patients receiving the drug.

Systemic Lupus Erythematosus : Cases of systemic lupus erythematosus have been reported with the use of ethosuximide. The physician should be alert to this possibility. Suicidal Behavior and Ideation : Antiepileptic drugs (AEDs), including ethosuximide, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.

Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% Cl: 1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated.

There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.

The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5-100 years) in the clinical trials analyzed.

Table 1 shows absolute and relative risk by indication for all evaluated AEDs. Table 1 Risk by indication for antiepileptic drugs in the pooled analysis Indication Placebo patients with Events Per 1000 Patients Drug Patients with Events Per 1000 Patients Relative Risk: Incidence of Events in Drug Patients /Incidence in Placebo Patients Risk Difference: Additional Drug Patients with Events Per 1000 Patients Epilepsy Psychiatric Other Total 1.0 5.7 1.0 2.4 3.4 8.5 1.8 4.3 3.5…

🤒 Adverse Reactions 188 words

ADVERSE REACTIONS Body As A Whole: Allergic reaction, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Gastrointestinal System: Gastrointestinal symptoms occur frequently and include anorexia, vague gastric upset, nausea and vomiting, cramps, epigastric and abdominal pain, weight loss, and diarrhea. There have been reports of gum hypertrophy and swelling of the tongue.

Hemopoietic System: Hemopoietic complications associated with the administration of ethosuximide have included leukopenia, agranulocytosis, pancytopenia, with or without bone marrow suppression, eosinophilia and thrombocytopenia (see WARNINGS ). Nervous System: Neurologic and sensory reactions reported during therapy with ethosuximide have included drowsiness, headache, dizziness, euphoria, hiccups, irritability, hyperactivity, lethargy, fatigue, and ataxia. Psychiatric or psychological aberrations associated with ethosuximide administration have included disturbances of sleep, night terrors, inability to concentrate, and aggressiveness.

These effects may be noted particularly in patients who have previously exhibited psychological abnormalities. There have been rare reports of paranoid psychosis, increased libido, and increased state of depression with overt suicidal intentions. Integumentary System: Dermatologic manifestations which have occurred with the administration of ethosuximide have included urticaria, pruritic erythematous rashes, Stevens-Johnson syndrome, and hirsutism.

Special Senses: Myopia . Genitourinary System: Vaginal bleeding, microscopic hematuria.

🆘 Overdosage 96 words

OVERDOSAGE Acute overdoses may produce nausea, vomiting, and CNS depression including coma with respiratory depression. A relationship between ethosuximide toxicity and its plasma levels has not been established. The therapeutic range of serum levels is 40 mcg/mL to 100 mcg/mL, although levels as high as 150 mcg/mL have been reported without signs of toxicity.

Treatment: Treatment should include emesis (unless the patient is or could rapidly become obtunded, comatose, or convulsing) or gastric lavage, activated charcoal, cathartics, and general supportive measures. Hemodialysis may be useful to treat ethosuximide overdose. Forced diuresis and exchange transfusions are ineffective.

🧬 Clinical Pharmacology 54 words

CLINICAL PHARMACOLOGY Ethosuximide suppresses the paroxysmal three cycle per second spike and wave activity associated with lapses of consciousness which is common in absence (petit mal) seizures. The frequency of epileptiform attacks is reduced, apparently by depression of the motor cortex and elevation of the threshold of the central nervous system to convulsive stimuli.

📦 How Supplied / Storage and Handling 73 words

HOW SUPPLIED Ethosuximide Capsules USP, 250 mg supplied as orange coloured, oblong shaped soft gelatin capsules printed with "250" in white ink, containing colourless to orange colour viscous liquid. NDC: 64380-878-06: Bottles of 100. Each capsule contains 250 mg ethosuximide.

Store at 25° C (77° F); excursions permitted to 15–30° C (59–86° F) [see USP Controlled Room Temperature]. Distributed by: Strides Pharma, Inc. Bridgewater, NJ 08807 Revised: 06/2026 Medication Guide available at: www.strides.com/medication-guides

📋 Description 74 words

DESCRIPTION Ethosuximide is an anticonvulsant succinimide, chemically designated as alpha-ethyl-alpha- methyl-succinimide, with the following structural formula: Each ethosuximide capsule contains 250 mg ethosuximide, USP. Also contains: D & C yellow No. 10, FD & C red # 3, gelatin, glycerin, isopropyl alcohol, lecithin, medium chain triglyceride, polyethylene glycol 400, and sorbitol solution and printing ink white IH-edible oil (Dewaxed Bleached Shellac Resins, Isopropyl Alcohol, Propylene Glycol, Sodium Lauryl Sulphate and Titanium Dioxide).

Molecular structure

💬 Patient Medication Information ~3 min read

MEDICATION GUIDE Ethosuximide Capsules, USP (Eth" oh sux' i mide) Read this Medication Guide before you start taking ethosuximide and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

If you have any questions about ethosuximide, ask your healthcare provider or pharmacist. What is the most important information I should know about ethosuximide? Do not stop taking ethosuximide without first talking to your healthcare provider.

Stopping ethosuximide suddenly can cause serious problems. Ethosuximide can cause serious side effects, including: 1. Rare but serious blood problems that may be life-threatening.

Call your healthcare provider right away if you have: fever, swollen glands, or sore throat that come and go or do not go away frequent infections or an infection that does not go away easy bruising red or purple spots on your body bleeding gums or nose bleeds severe fatigue or weakness 2. Drug reactions that may affect different parts of the body such as your liver, kidneys, heart, or blood cells. You may or may not have a rash with these types of reactions.

These reactions can be very serious and can cause death. Call your healthcare provider right away if you have any of these symptoms: joint pain and swelling muscle pain fatigue, weakness low-grade fever pain in the chest that is worse with breathing skin rash swollen lymph glands swelling of your face yellowing of your skin or the white part of your eyes 3. Like other antiepileptic drugs, ethosuximide may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you : thoughts about suicide or dying attempts to commit suicide new or worse depression new or worse anxiety feeling agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions?

Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop ethosuximide without first talking to a healthcare provider. Stopping ethosuximide suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. What is ethosuximide?

Ethosuximide is a prescription medicine used to treat absence (petit mal) seizures. Who should not take ethosuximide capsules? Do not take ethosuximide capsules if you are allergic to succinimides (methsuximide or ethosuximide), or any of the ingredients in ethosuximide capsules.

See the end of this Medication Guide for a complete list of ingredients in ethosuximide capsules. What should I tell my healthcare provider before taking ethosuximide? Before you take ethosuximide, tell your healthcare provider if you: have or had liver problems have or have had depression, mood problems or suicidal thoughts or behavior have any other medical conditions are pregnant or plan to become pregnant.

It is not known if ethosuximide can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking ethosuximide. You and your healthcare provider should decide if you should take ethosuximide while you are pregnant.

If you become pregnant while taking ethosuximide, talk to your healthca…

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