FDA Orange Book

Generic for Seroquel

Seroquel contains quetiapine. 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 Seroquel is quetiapine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Seroquel products in the Orange Book

Seroquel products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	EQ 100MG BASE	Marketed (Rx)	AB	12	AB
tablet, oral	EQ 150MG BASE	Discontinued	None	4	AB
tablet, oral	EQ 200MG BASE	Marketed (Rx)	AB	12	AB
tablet, oral	EQ 25MG BASE	Marketed (Rx)	AB	12	AB
tablet, oral	EQ 300MG BASE	Marketed (Rx)	AB	12	AB
tablet, oral	EQ 400MG BASE	Marketed (Rx)	AB	12	AB
tablet, oral	EQ 50MG BASE	Marketed (Rx)	AB	12	AB

NDA 020639, held by CHEPLAPHARM ARZNEIMITTEL GMBH. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic quetiapine

Approved generic versions of Seroquel
Company	ANDA	TE code	Approved	Strengths
ACCORD HEALTHCARE INC	202152	AB (A-rated, therapeutically equivalent)	March 27, 2012	EQ 100MG BASE, EQ 200MG BASE, EQ 25MG BASE, EQ 300MG BASE, EQ 400MG BASE, EQ 50MG BASE
AUROBINDO PHARMA LTD	091388	AB (A-rated, therapeutically equivalent)	March 27, 2012	EQ 100MG BASE, EQ 150MG BASE, EQ 200MG BASE, EQ 25MG BASE, EQ 300MG BASE, EQ 400MG BASE, EQ 50MG BASE
HIKMA PHARMACEUTICALS USA INC	090749	AB (A-rated, therapeutically equivalent)	March 27, 2012	EQ 100MG BASE, EQ 200MG BASE, EQ 300MG BASE, EQ 400MG BASE, EQ 50MG BASE
LUPIN LTD	201109	AB (A-rated, therapeutically equivalent)	March 27, 2012	EQ 100MG BASE, EQ 200MG BASE, EQ 25MG BASE, EQ 300MG BASE, EQ 400MG BASE, EQ 50MG BASE
RISING PHARMA HOLDINGS INC	077380	AB (A-rated, therapeutically equivalent)	March 27, 2012	EQ 100MG BASE, EQ 150MG BASE, EQ 200MG BASE, EQ 25MG BASE, EQ 300MG BASE, EQ 400MG BASE, EQ 50MG BASE
SCIEGEN PHARMACEUTICALS INC	090960	AB (A-rated, therapeutically equivalent)	March 27, 2012	EQ 100MG BASE, EQ 200MG BASE, EQ 25MG BASE, EQ 300MG BASE, EQ 400MG BASE, EQ 50MG BASE
TEVA PHARMACEUTICALS USA	077745	AB (A-rated, therapeutically equivalent)	March 27, 2012	EQ 100MG BASE, EQ 150MG BASE, EQ 200MG BASE, EQ 25MG BASE, EQ 300MG BASE, EQ 400MG BASE, EQ 50MG BASE
HIKMA PHARMACEUTICALS USA INC	090120	AB (A-rated, therapeutically equivalent)	March 27, 2012	EQ 25MG BASE
ALKEM LABORATORIES LTD	201504	AB (A-rated, therapeutically equivalent)	February 12, 2013	EQ 100MG BASE, EQ 150MG BASE, EQ 200MG BASE, EQ 25MG BASE, EQ 300MG BASE, EQ 400MG BASE, EQ 50MG BASE
UNICHEM LABORATORIES LTD	202674	AB (A-rated, therapeutically equivalent)	March 8, 2016	EQ 100MG BASE, EQ 200MG BASE, EQ 25MG BASE, EQ 300MG BASE, EQ 400MG BASE, EQ 50MG BASE
MACLEODS PHARMACEUTICALS LTD	203359	AB (A-rated, therapeutically equivalent)	May 17, 2016	EQ 100MG BASE, EQ 200MG BASE, EQ 25MG BASE, EQ 300MG BASE, EQ 400MG BASE, EQ 50MG BASE
HETERO LABS LTD UNIT V	204316	AB (A-rated, therapeutically equivalent)	June 16, 2022	EQ 100MG BASE, EQ 200MG BASE, EQ 25MG BASE, EQ 300MG BASE, EQ 400MG BASE, EQ 50MG BASE
PRINSTON PHARMACEUTICAL INC	206954	AB (A-rated, therapeutically equivalent)	August 24, 2022	EQ 100MG BASE, EQ 200MG BASE, EQ 25MG BASE, EQ 300MG BASE, EQ 400MG BASE, EQ 50MG BASE

Seroquel NDC codes

Questions

Is there a generic for Seroquel?

Yes. The generic name for Seroquel is quetiapine. 12 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 Seroquel?

The active ingredient in Seroquel is quetiapine, 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.