FDA Orange Book

Generic for Actoplus Met

Actoplus Met contains pioglitazone and metformin. 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 Actoplus Met is pioglitazone and metformin. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Actoplus Met products in the Orange Book

Actoplus Met products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	500MG;EQ 15MG BASE	Discontinued	None	4	AB
tablet, oral	850MG;EQ 15MG BASE	Marketed (Rx)	AB	4	AB

NDA 021842, 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 and metformin

Approved generic versions of Actoplus Met
Company	ANDA	TE code	Approved	Strengths
AUROBINDO PHARMA LTD	200823	AB (A-rated, therapeutically equivalent)	February 13, 2013	500MG;EQ 15MG BASE, 850MG;EQ 15MG BASE
TORRENT PHARMACEUTICALS LTD	202001	AB (A-rated, therapeutically equivalent)	February 13, 2013	500MG;EQ 15MG BASE, 850MG;EQ 15MG BASE
TEVA PHARMACEUTICALS USA	091155	AB (A-rated, therapeutically equivalent)	March 10, 2014	500MG;EQ 15MG BASE, 850MG;EQ 15MG BASE
MACLEODS PHARMACEUTICALS LTD	204802	AB (A-rated, therapeutically equivalent)	November 5, 2015	500MG;EQ 15MG BASE, 850MG;EQ 15MG BASE

Actoplus Met patents

Patents listed for Actoplus Met
Patent	Expires	Covers	Use code	NDA
9101660	January 22, 2027	Drug product	None	021842
9320714	February 3, 2029	Drug product	None	021842

Actoplus Met NDC codes

64764-158

Questions

Is there a generic for Actoplus Met?

Yes. The generic name for Actoplus Met is pioglitazone and metformin. 4 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 Actoplus Met?

The active ingredient in Actoplus Met is pioglitazone and metformin, per the FDA Orange Book.

When does the Actoplus Met patent expire?

The last patent listed for Actoplus Met in the Orange Book expires February 3, 2029. A listed patent expiry date is not a generic launch date.

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.