FDA Orange Book
Generic for Wellbutrin
Wellbutrin 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 is bupropion. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Wellbutrin products the Orange Book lists.
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Wellbutrin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Discontinued | None | 6 | AB |
| tablet, oral | 50MG | Discontinued | None | 0 | None |
| tablet, oral | 75MG | Discontinued | None | 6 | AB |
NDA 018644, 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 |
|---|---|---|---|---|
| PHARMAZONE | 075584 | AB (A-rated, therapeutically equivalent) | February 7, 2000 | 100MG, 75MG |
| AUROBINDO PHARMA USA INC | 075491 | AB (A-rated, therapeutically equivalent) | April 17, 2000 | 100MG, 75MG |
| APOTEX INC | 076143 | AB (A-rated, therapeutically equivalent) | January 17, 2006 | 100MG, 75MG |
| HERITAGE PHARMA LABS INC | 206975 | AB (A-rated, therapeutically equivalent) | August 19, 2016 | 100MG, 75MG |
| ALEMBIC PHARMACEUTICALS LTD | 203013 | AB (A-rated, therapeutically equivalent) | June 8, 2018 | 100MG, 75MG |
| CADILA PHARMACEUTICALS LTD | 208606 | AB (A-rated, therapeutically equivalent) | January 16, 2020 | 100MG, 75MG |
Questions
Is there a generic for Wellbutrin?
Yes. The generic name for Wellbutrin is bupropion. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Wellbutrin products the Orange Book lists.
What is the generic name for Wellbutrin?
The active ingredient in Wellbutrin 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.
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