FDA Orange Book
Generic for Wellbutrin XL
Wellbutrin XL 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 Wellbutrin XL 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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Wellbutrin XL products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 150MG | Marketed (Rx) | AB3 | 32 | AB1, AB2, AB3 |
| tablet, extended release, oral | 300MG | Marketed (Rx) | AB3 | 14 | AB3 |
NDA 021515, held by BAUSCH HEALTH US LLC. 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) | March 22, 2004 | 150MG |
| IMPAX LABORATORIES INC | 075913 | AB1 (A-rated, therapeutically equivalent) | March 22, 2004 | 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, 300MG |
| ACTAVIS LABORATORIES FL INC | 079094 | AB2 (A-rated, therapeutically equivalent) | March 24, 2009 | 150MG |
| ACTAVIS LABORATORIES FL INC | 079095 | AB1 (A-rated, therapeutically equivalent) | March 24, 2009 | 150MG |
| AUROBINDO PHARMA USA INC | 090325 | AB1 (A-rated, therapeutically equivalent) | April 8, 2010 | 150MG |
| WOCKHARDT LTD | 202189 | AB3 (A-rated, therapeutically equivalent) | November 21, 2012 | 150MG, 300MG |
| PRINSTON PHARMACEUTICAL INC | 202304 | AB1 (A-rated, therapeutically equivalent) | May 26, 2015 | 150MG |
| SCIEGEN PHARMACEUTICALS INC | 205794 | AB1 (A-rated, therapeutically equivalent) | March 1, 2016 | 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, 300MG |
| SCIEGEN PHARMACEUTICALS INC | 207479 | AB3 (A-rated, therapeutically equivalent) | April 12, 2017 | 150MG, 300MG |
| ANBISON LABORATORY CO LTD | 207224 | AB3 (A-rated, therapeutically equivalent) | June 30, 2017 | 150MG, 300MG |
| SINOTHERAPEUTICS INC | 208652 | AB3 (A-rated, therapeutically equivalent) | August 21, 2017 | 150MG, 300MG |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 210015 | AB3 (A-rated, therapeutically equivalent) | June 14, 2018 | 150MG, 300MG |
| ZYDUS PHARMACEUTICALS USA INC | 201567 | AB3 (A-rated, therapeutically equivalent) | July 23, 2018 | 150MG, 300MG |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 211347 | AB1 (A-rated, therapeutically equivalent) | October 16, 2018 | 150MG |
| ACCORD HEALTHCARE INC | 210497 | AB3 (A-rated, therapeutically equivalent) | October 31, 2018 | 150MG, 300MG |
| GRAVITI PHARMACEUTICALS PRIVATE LTD | 211020 | AB3 (A-rated, therapeutically equivalent) | January 28, 2019 | 150MG, 300MG |
| ZHEJIANG JUTAI PHARMACEUTICAL CO LTD | 211200 | AB3 (A-rated, therapeutically equivalent) | April 29, 2020 | 150MG, 300MG |
| GRANULES PHARMACEUTICALS INC | 215568 | AB3 (A-rated, therapeutically equivalent) | February 2, 2022 | 150MG, 300MG |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 216766 | AB2 (A-rated, therapeutically equivalent) | January 9, 2023 | 150MG |
| ANNORA PHARMA PRIVATE LTD | 217898 | AB3 (A-rated, therapeutically equivalent) | October 1, 2025 | 300MG |
| AUROBINDO PHARMA LTD | 216051 | AB3 (A-rated, therapeutically equivalent) | July 21, 2026 | 300MG |
Wellbutrin XL NDC codes
Questions
Is there a generic for Wellbutrin XL?
Yes. The generic name for Wellbutrin XL 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 Wellbutrin XL?
The active ingredient in Wellbutrin XL 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.