FDA Orange Book

Generic for Valtrex

Valtrex contains valacyclovir. 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 Valtrex is valacyclovir. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Valtrex products in the Orange Book

Valtrex products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	EQ 1GM BASE	Marketed (Rx)	AB	9	AB
tablet, oral	EQ 500MG BASE	Marketed (Rx)	AB	9	AB

NDA 020487, held by GLAXOSMITHKLINE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic valacyclovir

Approved generic versions of Valtrex
Company	ANDA	TE code	Approved	Strengths
SUN PHARMACEUTICAL INDUSTRIES LTD	076588	AB (A-rated, therapeutically equivalent)	January 31, 2007	EQ 1GM BASE, EQ 500MG BASE
AUROBINDO PHARMA LTD	090682	AB (A-rated, therapeutically equivalent)	May 24, 2010	EQ 1GM BASE, EQ 500MG BASE
CHARTWELL RX SCIENCES LLC	090216	AB (A-rated, therapeutically equivalent)	May 24, 2010	EQ 1GM BASE, EQ 500MG BASE
MYLAN PHARMACEUTICALS INC	078518	AB (A-rated, therapeutically equivalent)	May 24, 2010	EQ 1GM BASE, EQ 500MG BASE
RISING PHARMA HOLDINGS INC	079012	AB (A-rated, therapeutically equivalent)	May 24, 2010	EQ 1GM BASE, EQ 500MG BASE
JUBILANT GENERICS LTD	201506	AB (A-rated, therapeutically equivalent)	April 3, 2012	EQ 1GM BASE, EQ 500MG BASE
HETERO LABS LTD UNIT V	203047	AB (A-rated, therapeutically equivalent)	April 8, 2015	EQ 1GM BASE, EQ 500MG BASE
ZYDUS LIFESCIENCES LTD	079137	AB (A-rated, therapeutically equivalent)	December 29, 2017	EQ 1GM BASE, EQ 500MG BASE
YILING PHARMACEUTICAL LTD	209553	AB (A-rated, therapeutically equivalent)	March 18, 2020	EQ 1GM BASE, EQ 500MG BASE

Valtrex NDC codes

Questions

Is there a generic for Valtrex?

Yes. The generic name for Valtrex is valacyclovir. 9 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 Valtrex?

The active ingredient in Valtrex is valacyclovir, 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.