FDA Orange Book
Generic for Hygroton
Hygroton contains chlorthalidone. 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 Hygroton is chlorthalidone. 17 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Hygroton products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 25MG | Discontinued | None | 17 | AB |
| tablet, oral | 50MG | Discontinued | None | 17 | AB |
NDA 012283, held by SANOFI AVENTIS US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic chlorthalidone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMACEUTICAL INDUSTRIES INC | 089286 | AB (A-rated, therapeutically equivalent) | July 21, 1986 | 25MG, 50MG |
| INGENUS PHARMACEUTICALS LLC | 206904 | AB (A-rated, therapeutically equivalent) | March 30, 2017 | 25MG, 50MG |
| UMEDICA LABORATORIES PRIVATE LTD | 207222 | AB (A-rated, therapeutically equivalent) | May 24, 2018 | 25MG, 50MG |
| APPCO PHARMA LLC | 210742 | AB (A-rated, therapeutically equivalent) | October 12, 2018 | 25MG, 50MG |
| CHARTWELL RX SCIENCES LLC | 211063 | AB (A-rated, therapeutically equivalent) | February 26, 2019 | 25MG, 50MG |
| ZYDUS PHARMACEUTICALS USA INC | 207813 | AB (A-rated, therapeutically equivalent) | May 10, 2019 | 25MG, 50MG |
| AMNEAL PHARMACEUTICALS CO GMBH | 207204 | AB (A-rated, therapeutically equivalent) | July 1, 2019 | 25MG, 50MG |
| UNICHEM LABORATORIES LTD | 211627 | AB (A-rated, therapeutically equivalent) | August 6, 2019 | 25MG, 50MG |
| ALKEM LABORATORIES LTD | 213412 | AB (A-rated, therapeutically equivalent) | February 11, 2020 | 25MG, 50MG |
| AJANTA PHARMA LTD | 214129 | AB (A-rated, therapeutically equivalent) | November 27, 2020 | 25MG, 50MG |
| ADAPTIS PHARMA PRIVATE LTD | 211320 | AB (A-rated, therapeutically equivalent) | February 9, 2022 | 25MG, 50MG |
| PHARMOBEDIENT CONSULTING LLC | 212878 | AB (A-rated, therapeutically equivalent) | February 24, 2022 | 25MG |
| PHARMOBEDIENT CONSULTING LLC | 212875 | AB (A-rated, therapeutically equivalent) | February 24, 2022 | 50MG |
| MANKIND PHARMA LTD | 215587 | AB (A-rated, therapeutically equivalent) | August 4, 2022 | 25MG, 50MG |
| ALEMBIC PHARMACEUTICALS LTD | 216262 | AB (A-rated, therapeutically equivalent) | August 26, 2022 | 25MG, 50MG |
| IPCA LABORATORIES LTD | 209162 | AB (A-rated, therapeutically equivalent) | November 12, 2024 | 25MG, 50MG |
| MACLEODS PHARMACEUTICALS LTD | 212229 | AB (A-rated, therapeutically equivalent) | July 1, 2026 | 25MG, 50MG |
| MYLAN PHARMACEUTICALS INC | 086831 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 25MG, 50MG |
Questions
Is there a generic for Hygroton?
Yes. The generic name for Hygroton is chlorthalidone. 17 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 Hygroton?
The active ingredient in Hygroton is chlorthalidone, 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.