FDA Orange Book

Generic for Zoloft

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

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Zoloft products in the Orange Book

Zoloft products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
concentrate, oral	EQ 20MG BASE/ML	Marketed (Rx)	AA	2	AA
tablet, oral	EQ 100MG BASE	Marketed (Rx)	AB	12	AB
tablet, oral	EQ 150MG BASE	Discontinued	None	1	None
tablet, oral	EQ 200MG BASE	Discontinued	None	1	None
tablet, oral	EQ 25MG BASE	Marketed (Rx)	AB	12	AB
tablet, oral	EQ 50MG BASE	Marketed (Rx)	AB	12	AB

NDA 020990, 019839, held by VIATRIS SPECIALTY LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic sertraline

Approved generic versions of Zoloft
Company	ANDA	TE code	Approved	Strengths
STRIDES PHARMA GLOBAL PTE LTD	076934	AA (A-rated, therapeutically equivalent)	June 30, 2006	EQ 20MG BASE/ML
HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC	076465	AB (A-rated, therapeutically equivalent)	August 11, 2006	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
AUROBINDO PHARMA LTD	077206	AB (A-rated, therapeutically equivalent)	February 6, 2007	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
INVAGEN PHARMACEUTICALS INC	077397	AB (A-rated, therapeutically equivalent)	February 6, 2007	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
LUPIN LTD	077670	AB (A-rated, therapeutically equivalent)	February 6, 2007	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
MACLEODS PHARMACEUTICALS LTD	076882	AB (A-rated, therapeutically equivalent)	February 6, 2007	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
STRIDES PHARMA GLOBAL PTE LTD	076881	AB (A-rated, therapeutically equivalent)	February 6, 2007	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
SCIEGEN PHARMACEUTICALS INC	076442	AB (A-rated, therapeutically equivalent)	April 30, 2007	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
GRANULES INDIA LTD	078403	AB (A-rated, therapeutically equivalent)	January 8, 2008	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
AUROBINDO PHARMA LTD	078861	AA (A-rated, therapeutically equivalent)	October 31, 2008	EQ 20MG BASE/ML
REYOUNG CORPORATION	078677	AB (A-rated, therapeutically equivalent)	March 4, 2009	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
TP ANDA HOLDINGS LLC	078175	AB (A-rated, therapeutically equivalent)	July 21, 2010	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
ACCORD HEALTHCARE INC	202825	AB (A-rated, therapeutically equivalent)	November 7, 2014	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
ASCENT PHARMACEUTICALS INC	214790	AB (A-rated, therapeutically equivalent)	May 3, 2021	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
TP ANDA HOLDINGS LLC	077713	None (No TE code listed)	September 25, 2026	EQ 150MG BASE, EQ 200MG BASE

Zoloft NDC codes

Questions

Is there a generic for Zoloft?

Yes. The generic name for Zoloft is sertraline. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.

What is the generic name for Zoloft?

The active ingredient in Zoloft is sertraline, 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.