Generic for Paxil: Paroxetine

Yes. The generic name for Paxil is paroxetine. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 5 of the 10 Paxil products the Orange Book lists.

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Paxil products in the Orange Book

Paxil products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
capsule, oral	EQ 10MG BASE	Discontinued	None	0	None
capsule, oral	EQ 20MG BASE	Discontinued	None	0	None
capsule, oral	EQ 30MG BASE	Discontinued	None	0	None
capsule, oral	EQ 40MG BASE	Discontinued	None	0	None
suspension, oral	EQ 10MG BASE/5ML	Discontinued	None	2	AB
tablet, oral	EQ 10MG BASE	Marketed (Rx)	AB	8	AB
tablet, oral	EQ 20MG BASE	Marketed (Rx)	AB	8	AB
tablet, oral	EQ 30MG BASE	Marketed (Rx)	AB	8	AB
tablet, oral	EQ 40MG BASE	Marketed (Rx)	AB	8	AB
tablet, oral	EQ 50MG BASE	Discontinued	None	0	None

NDA 020885, 020710, 020031, held by APOTEX INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic paroxetine

Approved generic versions of Paxil
Company	ANDA	TE code	Approved	Strengths
APOTEX INC	075356	AB (A-rated, therapeutically equivalent)	July 30, 2003	EQ 10MG BASE, EQ 20MG BASE, EQ 30MG BASE, EQ 40MG BASE
CHARTWELL RX SCIENCES LLC	076618	AB (A-rated, therapeutically equivalent)	August 15, 2005	EQ 10MG BASE, EQ 20MG BASE, EQ 30MG BASE, EQ 40MG BASE
ZYDUS PHARMACEUTICALS USA INC	077584	AB (A-rated, therapeutically equivalent)	March 7, 2007	EQ 10MG BASE, EQ 20MG BASE, EQ 30MG BASE, EQ 40MG BASE
AUROBINDO PHARMA LTD	078406	AB (A-rated, therapeutically equivalent)	July 25, 2007	EQ 10MG BASE, EQ 20MG BASE, EQ 30MG BASE, EQ 40MG BASE
MYLAN PHARMACEUTICALS INC	078902	AB (A-rated, therapeutically equivalent)	March 13, 2008	EQ 10MG BASE, EQ 20MG BASE, EQ 30MG BASE, EQ 40MG BASE
OXFORD PHARMACEUTICALS LLC	076968	AB (A-rated, therapeutically equivalent)	June 21, 2010	EQ 10MG BASE, EQ 20MG BASE, EQ 30MG BASE, EQ 40MG BASE
PRINSTON PHARMACEUTICAL INC	203854	AB (A-rated, therapeutically equivalent)	October 31, 2014	EQ 10MG BASE, EQ 20MG BASE, EQ 30MG BASE, EQ 40MG BASE
NOVITIUM PHARMA LLC	215003	AB (A-rated, therapeutically equivalent)	September 3, 2021	EQ 10MG BASE/5ML
PHARMOBEDIENT CONSULTING LLC	211248	AB (A-rated, therapeutically equivalent)	November 2, 2021	EQ 10MG BASE, EQ 20MG BASE, EQ 30MG BASE, EQ 40MG BASE
ANNORA PHARMA PRIVATE LTD	219954	AB (A-rated, therapeutically equivalent)	March 5, 2026	EQ 10MG BASE/5ML

Paxil NDC codes

Questions

Is there a generic for Paxil?

Yes. The generic name for Paxil is paroxetine. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 5 of the 10 Paxil products the Orange Book lists.

What is the generic name for Paxil?

The active ingredient in Paxil is paroxetine, 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.

Generic for Paxil