FDA Orange Book
Generic for Zebeta
Zebeta contains bisoprolol. 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 Zebeta is bisoprolol. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Zebeta products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Discontinued | None | 11 | AB |
| tablet, oral | 5MG | Discontinued | None | 11 | AB |
NDA 019982, held by TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic bisoprolol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RUBICON RESEARCH LTD | 075643 | AB (A-rated, therapeutically equivalent) | November 16, 2000 | 10MG, 5MG |
| TP ANDA HOLDINGS LLC | 075474 | AB (A-rated, therapeutically equivalent) | October 25, 2002 | 10MG, 5MG |
| AUROBINDO PHARMA LTD | 077910 | AB (A-rated, therapeutically equivalent) | December 27, 2006 | 10MG, 5MG |
| UNICHEM LABORATORIES LTD | 078635 | AB (A-rated, therapeutically equivalent) | August 18, 2009 | 10MG, 5MG |
| ALEMBIC PHARMACEUTICALS LTD | 204891 | AB (A-rated, therapeutically equivalent) | January 11, 2017 | 10MG, 5MG |
| NOVITIUM PHARMA LLC | 215563 | AB (A-rated, therapeutically equivalent) | October 29, 2021 | 10MG, 5MG |
| ZYDUS LIFESCIENCES LTD | 215680 | AB (A-rated, therapeutically equivalent) | July 25, 2022 | 10MG, 5MG |
| PRINSTON PHARMACEUTICAL INC | 217368 | AB (A-rated, therapeutically equivalent) | July 14, 2023 | 10MG, 5MG |
| HARMAN FINOCHEM LTD | 217617 | AB (A-rated, therapeutically equivalent) | January 18, 2024 | 10MG, 5MG |
| UNIQUE PHARMACEUTICAL LABORATORIES | 219044 | AB (A-rated, therapeutically equivalent) | April 16, 2025 | 10MG, 5MG |
| MICRO LABS LTD | 218303 | AB (A-rated, therapeutically equivalent) | March 9, 2026 | 10MG, 5MG |
Questions
Is there a generic for Zebeta?
Yes. The generic name for Zebeta is bisoprolol. 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 Zebeta?
The active ingredient in Zebeta is bisoprolol, 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.