FDA Orange Book
Generic for Ziac
Ziac contains bisoprolol and hydrochlorothiazide. 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 Ziac is bisoprolol and hydrochlorothiazide. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Ziac products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG;6.25MG | Marketed (Rx) | AB | 9 | AB |
| tablet, oral | 2.5MG;6.25MG | Marketed (Rx) | AB | 9 | AB |
| tablet, oral | 5MG;6.25MG | Marketed (Rx) | AB | 9 | AB |
NDA 020186, 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 and hydrochlorothiazide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| EPIC PHARMA LLC | 075579 | AB (A-rated, therapeutically equivalent) | September 25, 2000 | 10MG;6.25MG, 2.5MG;6.25MG, 5MG;6.25MG |
| MYLAN PHARMACEUTICALS INC | 075768 | AB (A-rated, therapeutically equivalent) | September 25, 2000 | 10MG;6.25MG, 2.5MG;6.25MG, 5MG;6.25MG |
| UNICHEM LABORATORIES LTD | 079106 | AB (A-rated, therapeutically equivalent) | July 28, 2010 | 10MG;6.25MG, 2.5MG;6.25MG, 5MG;6.25MG |
| EDENBRIDGE PHARMACEUTICALS LLC | 212678 | AB (A-rated, therapeutically equivalent) | July 9, 2020 | 10MG;6.25MG, 2.5MG;6.25MG, 5MG;6.25MG |
| NOVITIUM PHARMA LLC | 215562 | AB (A-rated, therapeutically equivalent) | November 4, 2021 | 10MG;6.25MG, 2.5MG;6.25MG, 5MG;6.25MG |
| GLENMARK PHARMACEUTICALS LTD | 215995 | AB (A-rated, therapeutically equivalent) | January 26, 2022 | 10MG;6.25MG, 2.5MG;6.25MG, 5MG;6.25MG |
| CADILA HEALTHCARE LTD | 215666 | AB (A-rated, therapeutically equivalent) | November 4, 2022 | 10MG;6.25MG, 2.5MG;6.25MG, 5MG;6.25MG |
| AUROBINDO PHARMA LTD | 217922 | AB (A-rated, therapeutically equivalent) | January 21, 2026 | 10MG;6.25MG, 2.5MG;6.25MG, 5MG;6.25MG |
| UNIQUE PHARMACEUTICAL LABORATORIES | 219489 | AB (A-rated, therapeutically equivalent) | March 24, 2026 | 10MG;6.25MG, 2.5MG;6.25MG, 5MG;6.25MG |
Ziac NDC codes
Questions
Is there a generic for Ziac?
Yes. The generic name for Ziac is bisoprolol and hydrochlorothiazide. 9 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 Ziac?
The active ingredient in Ziac is bisoprolol and hydrochlorothiazide, 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.