FDA Orange Book
Generic for Banzel
Banzel contains rufinamide. 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 Banzel is rufinamide. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Banzel products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 40MG/ML | Marketed (Rx) | AB | 8 | AB |
| tablet, oral | 100MG | Discontinued | None | 1 | None |
| tablet, oral | 200MG | Marketed (Rx) | AB | 7 | AB |
| tablet, oral | 400MG | Marketed (Rx) | AB | 7 | AB |
NDA 201367, 021911, held by EISAI INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic rufinamide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| GLENMARK PHARMACEUTICALS LTD | 205075 | AB (A-rated, therapeutically equivalent) | May 16, 2016 | 200MG, 400MG |
| HIKMA PHARMACEUTICALS USA INC | 204988 | AB (A-rated, therapeutically equivalent) | May 16, 2016 | 200MG, 400MG |
| SCIEGEN PHARMACEUTICALS INC | 205095 | AB (A-rated, therapeutically equivalent) | May 16, 2016 | 200MG, 400MG |
| BIONPHARMA INC | 211388 | AB (A-rated, therapeutically equivalent) | April 23, 2019 | 40MG/ML |
| HIKMA PHARMACEUTICALS USA INC | 207363 | AB (A-rated, therapeutically equivalent) | April 23, 2019 | 40MG/ML |
| LUPIN LTD | 213457 | AB (A-rated, therapeutically equivalent) | December 18, 2020 | 40MG/ML |
| ALKEM LABORATORIES LTD | 213410 | AB (A-rated, therapeutically equivalent) | February 23, 2021 | 40MG/ML |
| HETERO LABS LTD UNIT III | 204993 | AB (A-rated, therapeutically equivalent) | May 11, 2021 | 200MG, 400MG |
| LUPIN LTD | 204964 | None (No TE code listed) | August 17, 2022 | 100MG, 200MG, 400MG |
| AUROBINDO PHARMA LTD | 216549 | AB (A-rated, therapeutically equivalent) | October 26, 2022 | 40MG/ML |
| CHARTWELL RX SCIENCES LLC | 214009 | AB (A-rated, therapeutically equivalent) | November 7, 2022 | 40MG/ML |
| MICRO LABS LTD | 216688 | AB (A-rated, therapeutically equivalent) | May 15, 2023 | 200MG, 400MG |
| AUROBINDO PHARMA LTD | 217230 | AB (A-rated, therapeutically equivalent) | June 16, 2023 | 200MG, 400MG |
| HETERO LABS LTD UNIT III | 216841 | AB (A-rated, therapeutically equivalent) | December 5, 2023 | 40MG/ML |
| MSN LABORATORIES PRIVATE LTD | 214817 | AB (A-rated, therapeutically equivalent) | April 15, 2025 | 40MG/ML |
Banzel NDC codes
Questions
Is there a generic for Banzel?
Yes. The generic name for Banzel is rufinamide. 11 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 Banzel?
The active ingredient in Banzel is rufinamide, 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.