FDA Orange Book
Generic for Thalitone
Thalitone 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 Thalitone is chlorthalidone. 17 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Thalitone products the Orange Book lists.
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Thalitone products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 15MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 25MG | Discontinued | None | 17 | AB |
NDA 019574, held by CASPER PHARMA 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 |
| INGENUS PHARMACEUTICALS LLC | 206904 | AB (A-rated, therapeutically equivalent) | March 30, 2017 | 25MG |
| UMEDICA LABORATORIES PRIVATE LTD | 207222 | AB (A-rated, therapeutically equivalent) | May 24, 2018 | 25MG |
| APPCO PHARMA LLC | 210742 | AB (A-rated, therapeutically equivalent) | October 12, 2018 | 25MG |
| CHARTWELL RX SCIENCES LLC | 211063 | AB (A-rated, therapeutically equivalent) | February 26, 2019 | 25MG |
| ZYDUS PHARMACEUTICALS USA INC | 207813 | AB (A-rated, therapeutically equivalent) | May 10, 2019 | 25MG |
| AMNEAL PHARMACEUTICALS CO GMBH | 207204 | AB (A-rated, therapeutically equivalent) | July 1, 2019 | 25MG |
| UNICHEM LABORATORIES LTD | 211627 | AB (A-rated, therapeutically equivalent) | August 6, 2019 | 25MG |
| ALKEM LABORATORIES LTD | 213412 | AB (A-rated, therapeutically equivalent) | February 11, 2020 | 25MG |
| AJANTA PHARMA LTD | 214129 | AB (A-rated, therapeutically equivalent) | November 27, 2020 | 25MG |
| ADAPTIS PHARMA PRIVATE LTD | 211320 | AB (A-rated, therapeutically equivalent) | February 9, 2022 | 25MG |
| PHARMOBEDIENT CONSULTING LLC | 212878 | AB (A-rated, therapeutically equivalent) | February 24, 2022 | 25MG |
| MANKIND PHARMA LTD | 215587 | AB (A-rated, therapeutically equivalent) | August 4, 2022 | 25MG |
| ALEMBIC PHARMACEUTICALS LTD | 216262 | AB (A-rated, therapeutically equivalent) | August 26, 2022 | 25MG |
| IPCA LABORATORIES LTD | 209162 | AB (A-rated, therapeutically equivalent) | November 12, 2024 | 25MG |
| MACLEODS PHARMACEUTICALS LTD | 212229 | AB (A-rated, therapeutically equivalent) | July 1, 2026 | 25MG |
| MYLAN PHARMACEUTICALS INC | 086831 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 25MG |
Thalitone NDC codes
Questions
Is there a generic for Thalitone?
Yes. The generic name for Thalitone is chlorthalidone. 17 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Thalitone products the Orange Book lists.
What is the generic name for Thalitone?
The active ingredient in Thalitone 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.