FDA Orange Book
Generic for Microzide
Microzide 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 Microzide is hydrochlorothiazide. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Microzide products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 12.5MG | Marketed (Rx) | AB | 5 | AB |
NDA 020504, held by TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D LLC. 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 |
|---|---|---|---|---|
| PRINSTON PHARMACEUTICAL INC | 075907 | AB (A-rated, therapeutically equivalent) | September 17, 2002 | 12.5MG |
| AUROBINDO PHARMA LTD | 078164 | AB (A-rated, therapeutically equivalent) | September 18, 2007 | 12.5MG |
| JUBILANT CADISTA PHARMACEUTICALS INC | 078391 | AB (A-rated, therapeutically equivalent) | February 11, 2008 | 12.5MG |
| UNICHEM LABORATORIES LTD | 090510 | AB (A-rated, therapeutically equivalent) | January 19, 2010 | 12.5MG |
| SCIEGEN PHARMACEUTICALS INC | 203561 | AB (A-rated, therapeutically equivalent) | January 14, 2019 | 12.5MG |
Microzide NDC codes
Questions
Is there a generic for Microzide?
Yes. The generic name for Microzide is hydrochlorothiazide. 5 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 Microzide?
The active ingredient in Microzide 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.