FDA Orange Book
Generic for Zyban
Zyban contains bupropion. 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 Zyban is bupropion. 22 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2, AB3.
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Zyban products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 100MG | Discontinued | None | 12 | AB1 |
| tablet, extended release, oral | 150MG | Discontinued | None | 32 | AB1, AB2, AB3 |
NDA 020711, held by GLAXOSMITHKLINE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic bupropion
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| EPIC PHARMA LLC | 075932 | AB1 (A-rated, therapeutically equivalent) | November 25, 2003 | 100MG, 150MG |
| IMPAX LABORATORIES INC | 075913 | AB1 (A-rated, therapeutically equivalent) | January 28, 2004 | 100MG, 150MG |
| IMPAX LABORATORIES INC | 075914 | AB2 (A-rated, therapeutically equivalent) | May 27, 2004 | 150MG |
| SANDOZ INC | 077475 | AB2 (A-rated, therapeutically equivalent) | March 12, 2008 | 150MG |
| ACTAVIS LABORATORIES FL INC | 077715 | AB3 (A-rated, therapeutically equivalent) | November 26, 2008 | 150MG |
| WATSON LABORATORIES INC | 077285 | AB3 (A-rated, therapeutically equivalent) | November 26, 2008 | 150MG |
| ACTAVIS LABORATORIES FL INC | 079095 | AB1 (A-rated, therapeutically equivalent) | March 24, 2009 | 100MG, 150MG |
| ACTAVIS LABORATORIES FL INC | 079094 | AB2 (A-rated, therapeutically equivalent) | March 24, 2009 | 150MG |
| AUROBINDO PHARMA USA INC | 090325 | AB1 (A-rated, therapeutically equivalent) | April 8, 2010 | 100MG, 150MG |
| WOCKHARDT LTD | 202189 | AB3 (A-rated, therapeutically equivalent) | November 21, 2012 | 150MG |
| PRINSTON PHARMACEUTICAL INC | 202304 | AB1 (A-rated, therapeutically equivalent) | May 26, 2015 | 100MG, 150MG |
| SCIEGEN PHARMACEUTICALS INC | 205794 | AB1 (A-rated, therapeutically equivalent) | March 1, 2016 | 100MG, 150MG |
| SCIEGEN PHARMACEUTICALS INC | 206122 | AB2 (A-rated, therapeutically equivalent) | August 17, 2016 | 150MG |
| LUPIN LTD | 090693 | AB3 (A-rated, therapeutically equivalent) | April 6, 2017 | 150MG |
| SCIEGEN PHARMACEUTICALS INC | 207479 | AB3 (A-rated, therapeutically equivalent) | April 12, 2017 | 150MG |
| ANBISON LABORATORY CO LTD | 207224 | AB3 (A-rated, therapeutically equivalent) | June 30, 2017 | 150MG |
| SINOTHERAPEUTICS INC | 208652 | AB3 (A-rated, therapeutically equivalent) | August 21, 2017 | 150MG |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 210015 | AB3 (A-rated, therapeutically equivalent) | June 14, 2018 | 150MG |
| ZYDUS PHARMACEUTICALS USA INC | 201567 | AB3 (A-rated, therapeutically equivalent) | July 23, 2018 | 150MG |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 211347 | AB1 (A-rated, therapeutically equivalent) | October 16, 2018 | 100MG, 150MG |
| ACCORD HEALTHCARE INC | 210497 | AB3 (A-rated, therapeutically equivalent) | October 31, 2018 | 150MG |
| GRAVITI PHARMACEUTICALS PRIVATE LTD | 211020 | AB3 (A-rated, therapeutically equivalent) | January 28, 2019 | 150MG |
| ZHEJIANG JUTAI PHARMACEUTICAL CO LTD | 211200 | AB3 (A-rated, therapeutically equivalent) | April 29, 2020 | 150MG |
| GRANULES PHARMACEUTICALS INC | 215568 | AB3 (A-rated, therapeutically equivalent) | February 2, 2022 | 150MG |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 216766 | AB2 (A-rated, therapeutically equivalent) | January 9, 2023 | 150MG |
| ANNORA PHARMA PRIVATE LTD | 216800 | AB1 (A-rated, therapeutically equivalent) | May 31, 2023 | 100MG |
| GRANULES PHARMACEUTICALS INC | 218385 | AB1 (A-rated, therapeutically equivalent) | October 17, 2024 | 100MG |
| IPCA LABORATORIES LTD | 207874 | AB1 (A-rated, therapeutically equivalent) | May 2, 2025 | 100MG |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 220529 | AB1 (A-rated, therapeutically equivalent) | May 4, 2026 | 100MG |
| MACLEODS PHARMACEUTICALS LTD | 218567 | AB1 (A-rated, therapeutically equivalent) | June 23, 2026 | 100MG |
Questions
Is there a generic for Zyban?
Yes. The generic name for Zyban is bupropion. 22 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2, AB3.
What is the generic name for Zyban?
The active ingredient in Zyban is bupropion, 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.