Quick answers
- What is Ethosuximide used for?
- The FDA-approved label (Zarontin, Parke-Davis Div of Pfizer Inc, May 25, 2026) says: “Zarontin is indicated for the control of absence (petit mal) epilepsy.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ethosuximide have a boxed warning?
- No. None of the 12 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ethosuximide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ethosuximide been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started July 29, 2021 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Ethosuximide?
- 9 companies list prescription products of Ethosuximide in the FDA NDC Directory, including Parke-Davis Div of Pfizer Inc, Chartwell RX, LLC and Epic Pharma, LLC.
What Ethosuximide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Zarontin is indicated for the control of absence (petit mal) epilepsy.
— FDA label: Zarontin, Parke-Davis Div of Pfizer Inc, effective May 25, 2026. Read the full label on DailyMed →
The FDA has 12 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 12 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution · Capsule · Capsule, liquid filled |
|---|---|
| Route | Oral |
| Prescription products | 12 in the FDA NDC Directory |
| Brand names | Zarontin |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| ethosuximide 250 mg capsule | Generic | $0.2623 per capsule |
| ethosuximide 250 mg capsule | Brand: Zarontin | $1.31 per capsule |
| ethosuximide 250 mg capsule, liquid filled | Generic | $0.2623 per capsule |
| ethosuximide 250 mg/5 mL solution | Generic | $0.1044 per mL |
NADAC list of November 4, 2026; these prices took effect between January 1, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Parke-Davis Div of Pfizer Inc2 products
- Chartwell RX, LLC2 products
- Epic Pharma, LLC2 products
- Chartwell Governmental & Specialty RX, LLC.1 product
- PAI Holdings, LLC dba PAI Pharma1 product
- Mylan Pharmaceuticals Inc.1 product
- Bryant Ranch Prepack1 product
- Strides Pharma Science Limited1 product
- Bionpharma Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA012380 ZARONTIN | Parke Davis | November 2, 1960 | 24, latest October 28, 2021 2021: Labeling · 2016: Labeling · 2012: Labeling |
Generic approvals (7)
- ANDA080258Parke-Davis · February 13, 1974
- ANDA040253Pharm Assoc · November 22, 2000
- ANDA040430Bionpharma · October 28, 2002
- ANDA040506Chartwell Rx · December 22, 2003
- ANDA200892Heritage Pharms Inc · September 25, 2012
- ANDA211928Onesource · February 19, 2019
- ANDA210654Puracap Pharm LLC · March 16, 2020
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
July 29, 2021 · Class II · Terminated · D-0723-2021
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0670-16 — PAI Holdings, LLC. dba Pharmaceutical Associates Inc
-
September 12, 2019 · Class III · Terminated · D-0002-2020
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made in Netherlands Distributed by Parke-Davis Division of Pfizer In NY, NY 10017, NDC 0071-0237-24 — Pfizer Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 197682, 201737, 251322, 755357 |
|---|---|
| SPL set ID of the quoted label | 0e008f33-70a1-4bc6-b3a0-d45214418ab6 |
| FDA labels (SPL) | 12 |
| FDA applications | NDA012380, 7 ANDA |
| Active ingredients (FDA) | ETHOSUXIMIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Zarontin, Parke-Davis Div of Pfizer Inc, effective May 25, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →