FDA Orange Book
Generic for Zaroxolyn
Zaroxolyn contains metolazone. 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 Zaroxolyn is metolazone. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Zaroxolyn products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Discontinued | None | 9 | AB |
| tablet, oral | 2.5MG | Discontinued | None | 9 | AB |
| tablet, oral | 5MG | Discontinued | None | 9 | AB |
NDA 017386, held by I3 PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic metolazone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 076466 | AB (A-rated, therapeutically equivalent) | December 19, 2003 | 10MG, 5MG |
| SANDOZ INC | 076732 | AB (A-rated, therapeutically equivalent) | December 19, 2003 | 2.5MG |
| MYLAN PHARMACEUTICALS INC | 076698 | AB (A-rated, therapeutically equivalent) | October 19, 2004 | 10MG, 2.5MG, 5MG |
| ALEMBIC PHARMACEUTICALS LTD | 213251 | AB (A-rated, therapeutically equivalent) | December 2, 2020 | 10MG, 2.5MG, 5MG |
| INNOGENIX LLC | 213827 | AB (A-rated, therapeutically equivalent) | March 30, 2021 | 10MG, 2.5MG, 5MG |
| UNICHEM LABORATORIES LTD | 214799 | AB (A-rated, therapeutically equivalent) | March 30, 2021 | 10MG, 2.5MG, 5MG |
| RUBICON RESEARCH LTD | 215184 | AB (A-rated, therapeutically equivalent) | August 20, 2021 | 10MG, 2.5MG, 5MG |
| RENATA PLC | 215616 | AB (A-rated, therapeutically equivalent) | October 24, 2022 | 10MG, 2.5MG, 5MG |
| NE RX PHARMA LLC | 216216 | AB (A-rated, therapeutically equivalent) | October 25, 2022 | 10MG, 2.5MG, 5MG |
| ACERTIS PHARMACEUTICALS LLC | 218606 | AB (A-rated, therapeutically equivalent) | April 17, 2024 | 10MG, 2.5MG, 5MG |
Questions
Is there a generic for Zaroxolyn?
Yes. The generic name for Zaroxolyn is metolazone. 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 Zaroxolyn?
The active ingredient in Zaroxolyn is metolazone, 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.