FDA Orange Book
Generic for Mysoline
Mysoline contains primidone. 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 Mysoline is primidone. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Mysoline products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 250MG | Marketed (Rx) | AB | 7 | AB |
| tablet, oral | 50MG | Marketed (Rx) | AB | 6 | AB |
NDA 009170, held by VALEANT PHARMACEUTICALS INTERNATIONAL. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic primidone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| OXFORD PHARMACEUTICALS LLC | 040586 | AB (A-rated, therapeutically equivalent) | February 24, 2005 | 250MG, 50MG |
| TP ANDA HOLDINGS LLC | 040626 | AB (A-rated, therapeutically equivalent) | September 29, 2005 | 250MG, 50MG |
| AMNEAL PHARMACEUTICAL | 040866 | AB (A-rated, therapeutically equivalent) | April 23, 2008 | 250MG, 50MG |
| RUBICON RESEARCH LTD | 214896 | AB (A-rated, therapeutically equivalent) | June 28, 2022 | 250MG, 50MG |
| CARNEGIE PHARMACEUTICALS LLC | 218366 | AB (A-rated, therapeutically equivalent) | January 23, 2024 | 250MG, 50MG |
| LANNETT CO INC | 084903 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 250MG, 50MG |
| WATSON LABORATORIES INC | 083551 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 250MG |
Mysoline NDC codes
Questions
Is there a generic for Mysoline?
Yes. The generic name for Mysoline is primidone. 7 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 Mysoline?
The active ingredient in Mysoline is primidone, 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.