FDA Orange Book
Generic for Zonegran
Zonegran contains zonisamide. 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 Zonegran is zonisamide. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Zonegran and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Zonegran products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Marketed (Rx) | AB | 7 | AB |
| capsule, oral | 25MG | Marketed (Rx) | AB | 7 | AB |
| capsule, oral | 50MG | Discontinued | None | 7 | AB |
NDA 020789, held by ADVANZ PHARMA (US) CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic zonisamide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA LTD | 077645 | AB (A-rated, therapeutically equivalent) | December 22, 2005 | 100MG, 25MG, 50MG |
| GRANULES INDIA LTD | 077636 | AB (A-rated, therapeutically equivalent) | December 22, 2005 | 100MG, 25MG, 50MG |
| GLENMARK PHARMACEUTICALS INC USA | 077651 | AB (A-rated, therapeutically equivalent) | January 30, 2006 | 100MG, 25MG, 50MG |
| INVAGEN PHARMACEUTICALS INC | 077869 | AB (A-rated, therapeutically equivalent) | May 31, 2006 | 100MG, 25MG, 50MG |
| BIONPHARMA INC | 077813 | AB (A-rated, therapeutically equivalent) | August 16, 2006 | 100MG, 25MG, 50MG |
| ZYDUS LIFESCIENCES LTD | 077625 | AB (A-rated, therapeutically equivalent) | October 16, 2006 | 100MG, 25MG, 50MG |
| UNICHEM LABORATORIES LTD | 214492 | AB (A-rated, therapeutically equivalent) | January 26, 2021 | 100MG, 25MG, 50MG |
Zonegran NDC codes
Questions
Is there a generic for Zonegran?
Yes. The generic name for Zonegran is zonisamide. 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 Zonegran?
The active ingredient in Zonegran is zonisamide, 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.