FDA Orange Book
Generic for Aldactazide
Aldactazide contains spironolactone and 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 Aldactazide is spironolactone and hydrochlorothiazide. 3 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 Aldactazide products the Orange Book lists.
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Aldactazide products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 25MG;25MG | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | 50MG;50MG | Discontinued | None | 0 | None |
NDA 012616, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic spironolactone and hydrochlorothiazide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMACEUTICAL INDUSTRIES INC | 089534 | AB (A-rated, therapeutically equivalent) | July 2, 1987 | 25MG;25MG |
| RUBICON RESEARCH LTD | 220884 | AB (A-rated, therapeutically equivalent) | September 10, 2026 | 25MG;25MG |
| MYLAN PHARMACEUTICALS INC | 086513 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 25MG;25MG |
Aldactazide NDC codes
Questions
Is there a generic for Aldactazide?
Yes. The generic name for Aldactazide is spironolactone and hydrochlorothiazide. 3 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 Aldactazide products the Orange Book lists.
What is the generic name for Aldactazide?
The active ingredient in Aldactazide is spironolactone and 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.