FDA Orange Book
Generic for Hydrodiuril
Hydrodiuril 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 Hydrodiuril is hydrochlorothiazide. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Hydrodiuril products the Orange Book lists.
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Hydrodiuril products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Discontinued | None | 0 | None |
| tablet, oral | 25MG | Discontinued | None | 8 | AB |
| tablet, oral | 50MG | Discontinued | None | 8 | AB |
NDA 011835, held by MERCK AND CO 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 Hydrodiuril?
Yes. The generic name for Hydrodiuril is hydrochlorothiazide. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Hydrodiuril products the Orange Book lists.
What is the generic name for Hydrodiuril?
The active ingredient in Hydrodiuril 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.