FDA Orange Book
Generic for Aldactone
Aldactone contains spironolactone. 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 Aldactone is spironolactone. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Aldactone and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Aldactone products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Marketed (Rx) | AB | 10 | AB |
| tablet, oral | 25MG | Marketed (Rx) | AB | 10 | AB |
| tablet, oral | 50MG | Marketed (Rx) | AB | 10 | AB |
NDA 012151, 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
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMACEUTICAL INDUSTRIES INC | 089424 | AB (A-rated, therapeutically equivalent) | August 11, 1999 | 100MG, 25MG, 50MG |
| MYLAN PHARMACEUTICALS INC | 040424 | AB (A-rated, therapeutically equivalent) | August 20, 2001 | 100MG, 25MG, 50MG |
| OXFORD PHARMACEUTICALS LLC | 040750 | AB (A-rated, therapeutically equivalent) | August 29, 2006 | 100MG, 25MG, 50MG |
| AMNEAL PHARMACEUTICALS OF NEW YORK LLC | 091426 | AB (A-rated, therapeutically equivalent) | July 2, 2010 | 100MG, 25MG, 50MG |
| AUROBINDO PHARMA LTD | 202187 | AB (A-rated, therapeutically equivalent) | March 6, 2014 | 100MG, 25MG, 50MG |
| JUBILANT GENERICS LTD | 203253 | AB (A-rated, therapeutically equivalent) | April 23, 2014 | 100MG, 25MG, 50MG |
| ACCORD HEALTHCARE INC | 203512 | AB (A-rated, therapeutically equivalent) | September 19, 2016 | 100MG, 25MG, 50MG |
| ZYDUS PHARMACEUTICALS USA INC | 205936 | AB (A-rated, therapeutically equivalent) | July 18, 2018 | 100MG, 25MG, 50MG |
| GRAVITI PHARMACEUTICALS PRIVATE LTD | 219494 | AB (A-rated, therapeutically equivalent) | January 23, 2025 | 100MG, 25MG, 50MG |
| ANNORA PHARMA PRIVATE LTD | 217761 | AB (A-rated, therapeutically equivalent) | July 25, 2025 | 100MG, 25MG, 50MG |
Aldactone NDC codes
Questions
Is there a generic for Aldactone?
Yes. The generic name for Aldactone is spironolactone. 10 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 Aldactone?
The active ingredient in Aldactone is spironolactone, 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.