FDA Orange Book
Generic for Actos
Actos contains pioglitazone. 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 Actos is pioglitazone. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Actos products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 15MG BASE | Marketed (Rx) | AB | 11 | AB |
| tablet, oral | EQ 30MG BASE | Marketed (Rx) | AB | 11 | AB |
| tablet, oral | EQ 45MG BASE | Marketed (Rx) | AB | 11 | AB |
NDA 021073, held by TAKEDA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic pioglitazone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CHARTWELL RX SCIENCES LLC | 076798 | AB (A-rated, therapeutically equivalent) | October 26, 2012 | EQ 15MG BASE, EQ 30MG BASE, EQ 45MG BASE |
| MACLEODS PHARMACEUTICALS LTD | 202467 | AB (A-rated, therapeutically equivalent) | February 6, 2013 | EQ 15MG BASE, EQ 30MG BASE, EQ 45MG BASE |
| ACCORD HEALTHCARE INC | 200044 | AB (A-rated, therapeutically equivalent) | February 13, 2013 | EQ 15MG BASE, EQ 30MG BASE, EQ 45MG BASE |
| AIPING PHARMACEUTICAL INC | 078670 | AB (A-rated, therapeutically equivalent) | February 13, 2013 | EQ 15MG BASE, EQ 30MG BASE, EQ 45MG BASE |
| AUROBINDO PHARMA LTD | 200268 | AB (A-rated, therapeutically equivalent) | February 13, 2013 | EQ 15MG BASE, EQ 30MG BASE, EQ 45MG BASE |
| ZYDUS PHARMACEUTICALS USA INC | 202456 | AB (A-rated, therapeutically equivalent) | February 13, 2013 | EQ 15MG BASE, EQ 30MG BASE, EQ 45MG BASE |
| TEVA PHARMACEUTICALS USA | 077210 | AB (A-rated, therapeutically equivalent) | January 10, 2014 | EQ 15MG BASE, EQ 30MG BASE, EQ 45MG BASE |
| ANNORA PHARMA PRIVATE LTD | 204133 | AB (A-rated, therapeutically equivalent) | April 7, 2014 | EQ 15MG BASE, EQ 30MG BASE, EQ 45MG BASE |
| PURACAP PHARMACEUTICAL LLC | 206738 | AB (A-rated, therapeutically equivalent) | October 6, 2017 | EQ 15MG BASE, EQ 30MG BASE, EQ 45MG BASE |
| PRINSTON PHARMACEUTICAL INC | 207806 | AB (A-rated, therapeutically equivalent) | April 17, 2018 | EQ 15MG BASE, EQ 30MG BASE, EQ 45MG BASE |
| SOLGEN PHARMA LLC | 210165 | AB (A-rated, therapeutically equivalent) | January 22, 2021 | EQ 15MG BASE, EQ 30MG BASE, EQ 45MG BASE |
Actos NDC codes
Questions
Is there a generic for Actos?
Yes. The generic name for Actos is pioglitazone. 11 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 Actos?
The active ingredient in Actos is pioglitazone, 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.
More on Actos and Pioglitazone
- What is Pioglitazone used for?FDA label uses
- Is Pioglitazone a controlled substance?Federal schedule
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- Peroxisome Proliferator Receptor gamma Agonists listFDA drug class
- Thiazolidinediones listFDA drug class
- NDC 64764-151Actos NDC record
- NDC 64764-301Actos NDC record
- NDC 64764-451Actos NDC record