FDA Orange Book
Generic for Oretic
Oretic contains 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 Oretic is hydrochlorothiazide. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Oretic products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 25MG | Discontinued | None | 8 | AB |
| tablet, oral | 50MG | Discontinued | None | 8 | AB |
NDA 011971, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic hydrochlorothiazide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| LEADING PHARMA LLC | 040702 | AB (A-rated, therapeutically equivalent) | March 16, 2007 | 25MG, 50MG |
| AUROBINDO PHARMA LTD | 040780 | AB (A-rated, therapeutically equivalent) | July 20, 2007 | 25MG, 50MG |
| UNICHEM LABORATORIES LTD | 040907 | AB (A-rated, therapeutically equivalent) | August 15, 2008 | 25MG, 50MG |
| ACCORD HEALTHCARE INC | 202556 | AB (A-rated, therapeutically equivalent) | September 24, 2012 | 25MG, 50MG |
| SCIEGEN PHARMACEUTICALS INC | 203018 | AB (A-rated, therapeutically equivalent) | July 23, 2014 | 25MG, 50MG |
| HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC | 085182 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 25MG, 50MG |
| IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA | 083177 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 25MG, 50MG |
| OXFORD PHARMACEUTICALS LLC | 087059 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 25MG |
| OXFORD PHARMACEUTICALS LLC | 087068 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 50MG |
Questions
Is there a generic for Oretic?
Yes. The generic name for Oretic is hydrochlorothiazide. 8 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 Oretic?
The active ingredient in Oretic is 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.