FDA Orange Book

Generic for Celontin

Celontin contains methsuximide. 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 Celontin is methsuximide. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Celontin products the Orange Book lists.

Run it in Rivvi

Map Celontin and your other top fills to their generics

Every strength in RxNorm, with brands that have no generic flagged.

Build the map

Free to start. Opens Rivvi, the AI workspace for healthcare teams.

Celontin products in the Orange Book

Celontin products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, oral150MGDiscontinuedNone0None
capsule, oral300MGMarketed (Rx)AB1AB

NDA 010596, 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 methsuximide

Approved generic versions of Celontin
CompanyANDATE codeApprovedStrengths
NOVITIUM PHARMA LLC217213AB (A-rated, therapeutically equivalent)May 1, 2023300MG

Celontin NDC codes

Questions

Is there a generic for Celontin?

Yes. The generic name for Celontin is methsuximide. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Celontin products the Orange Book lists.

What is the generic name for Celontin?

The active ingredient in Celontin is methsuximide, 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.

More on Celontin and Methsuximide

Try it on your own data today.

Free to start. Most teams are using it the same day.