FDA Orange Book
Generic for Hyzaar
Hyzaar contains losartan 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 Hyzaar is losartan and hydrochlorothiazide. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Hyzaar products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 12.5MG;100MG | Marketed (Rx) | AB | 10 | AB |
| tablet, oral | 12.5MG;50MG | Marketed (Rx) | AB | 11 | AB |
| tablet, oral | 25MG;100MG | Marketed (Rx) | AB | 11 | AB |
NDA 020387, held by ORGANON LLC A SUB OF ORGANON AND CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic losartan and hydrochlorothiazide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA | 077157 | AB (A-rated, therapeutically equivalent) | April 6, 2010 | 12.5MG;100MG, 12.5MG;50MG, 25MG;100MG |
| LUPIN LTD | 078245 | AB (A-rated, therapeutically equivalent) | May 21, 2010 | 12.5MG;100MG, 12.5MG;50MG, 25MG;100MG |
| CHARTWELL RX SCIENCES LLC | 077948 | AB (A-rated, therapeutically equivalent) | August 19, 2010 | 12.5MG;100MG, 12.5MG;50MG, 25MG;100MG |
| AUROBINDO PHARMA LTD | 091629 | AB (A-rated, therapeutically equivalent) | October 6, 2010 | 12.5MG;100MG, 12.5MG;50MG, 25MG;100MG |
| ZYDUS PHARMACEUTICALS USA INC | 078385 | AB (A-rated, therapeutically equivalent) | October 6, 2010 | 12.5MG;50MG, 25MG;100MG |
| ALEMBIC PHARMACEUTICALS LTD | 091617 | AB (A-rated, therapeutically equivalent) | February 17, 2012 | 12.5MG;100MG, 12.5MG;50MG, 25MG;100MG |
| MACLEODS PHARMACEUTICALS LTD | 202289 | AB (A-rated, therapeutically equivalent) | August 9, 2012 | 12.5MG;100MG, 12.5MG;50MG, 25MG;100MG |
| JUBILANT CADISTA PHARMACEUTICALS INC | 201845 | AB (A-rated, therapeutically equivalent) | September 18, 2012 | 12.5MG;100MG, 12.5MG;50MG, 25MG;100MG |
| UNICHEM LABORATORIES LTD | 204832 | AB (A-rated, therapeutically equivalent) | July 21, 2017 | 12.5MG;100MG, 12.5MG;50MG, 25MG;100MG |
| PRINSTON PHARMACEUTICAL INC | 204901 | AB (A-rated, therapeutically equivalent) | November 6, 2017 | 12.5MG;100MG, 12.5MG;50MG, 25MG;100MG |
| HETERO LABS LTD UNIT V | 219869 | AB (A-rated, therapeutically equivalent) | May 27, 2026 | 12.5MG;100MG, 12.5MG;50MG, 25MG;100MG |
Hyzaar NDC codes
Questions
Is there a generic for Hyzaar?
Yes. The generic name for Hyzaar is losartan and hydrochlorothiazide. 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 Hyzaar?
The active ingredient in Hyzaar is losartan 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.
More on Hyzaar and Losartan and Hydrochlorothiazide
- What is Losartan and Hydrochlorothiazide used for?FDA label uses
- Is Losartan and Hydrochlorothiazide a controlled substance?Federal schedule
- Angiotensin 2 Receptor Blockers listFDA drug class
- Thiazide Diuretics listFDA drug class
- NDC 78206-139Hyzaar NDC record
- NDC 78206-140Hyzaar NDC record
- NDC 78206-141Hyzaar NDC record