FDA Orange Book

Generic for Zarontin

Zarontin contains ethosuximide. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Zarontin is ethosuximide. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Zarontin products in the Orange Book

Zarontin products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, oral250MGMarketed (Rx)AB4AB

NDA 012380, held by PARKE DAVIS DIV WARNER LAMBERT CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic ethosuximide

Approved generic versions of Zarontin
CompanyANDATE codeApprovedStrengths
BIONPHARMA INC040430AB (A-rated, therapeutically equivalent)October 28, 2002250MG
EPIC PHARMA LLC040686AB (A-rated, therapeutically equivalent)May 28, 2008250MG
ONESOURCE SOFTGELS PTE LTD211928AB (A-rated, therapeutically equivalent)February 19, 2019250MG
PURACAP PHARMACEUTICAL LLC210654AB (A-rated, therapeutically equivalent)March 16, 2020250MG

Zarontin NDC codes

Questions

Is there a generic for Zarontin?

Yes. The generic name for Zarontin is ethosuximide. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Zarontin?

The active ingredient in Zarontin is ethosuximide, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

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