FDA Orange Book

Generic for Depakote

Depakote contains divalproex. 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 Depakote is divalproex. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Depakote products in the Orange Book

Depakote products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
capsule, delayed rel pellets, oral	EQ 125MG VALPROIC ACID	Marketed (Rx)	AB	5	AB
tablet, delayed release, oral	EQ 125MG VALPROIC ACID	Marketed (Rx)	AB	10	AB
tablet, delayed release, oral	EQ 250MG VALPROIC ACID	Marketed (Rx)	AB	10	AB
tablet, delayed release, oral	EQ 500MG VALPROIC ACID	Marketed (Rx)	AB	10	AB

NDA 019680, 018723, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic divalproex

Approved generic versions of Depakote
Company	ANDA	TE code	Approved	Strengths
DR REDDYS LABORATORIES LTD	078755	AB (A-rated, therapeutically equivalent)	July 29, 2008	EQ 125MG VALPROIC ACID, EQ 250MG VALPROIC ACID, EQ 500MG VALPROIC ACID
INVATECH PHARMA SOLUTIONS LLC	078290	AB (A-rated, therapeutically equivalent)	July 29, 2008	EQ 125MG VALPROIC ACID, EQ 250MG VALPROIC ACID, EQ 500MG VALPROIC ACID
SUN PHARMACEUTICAL INDUSTRIES LTD	078597	AB (A-rated, therapeutically equivalent)	July 29, 2008	EQ 125MG VALPROIC ACID, EQ 250MG VALPROIC ACID, EQ 500MG VALPROIC ACID
UPSHER SMITH LABORATORIES LLC	078182	AB (A-rated, therapeutically equivalent)	July 29, 2008	EQ 125MG VALPROIC ACID, EQ 250MG VALPROIC ACID, EQ 500MG VALPROIC ACID
CHARTWELL RX SCIENCES LLC	077296	AB (A-rated, therapeutically equivalent)	July 31, 2008	EQ 125MG VALPROIC ACID, EQ 250MG VALPROIC ACID, EQ 500MG VALPROIC ACID
ORBION PHARMACEUTICALS PRIVATE LTD	078853	AB (A-rated, therapeutically equivalent)	November 25, 2008	EQ 125MG VALPROIC ACID, EQ 250MG VALPROIC ACID, EQ 500MG VALPROIC ACID
DR REDDYS LABORATORIES LTD	078979	AB (A-rated, therapeutically equivalent)	January 23, 2009	EQ 125MG VALPROIC ACID
ZYDUS PHARMACEUTICALS USA INC	078919	AB (A-rated, therapeutically equivalent)	January 27, 2009	EQ 125MG VALPROIC ACID
ZYDUS PHARMACEUTICALS USA INC	077100	AB (A-rated, therapeutically equivalent)	March 5, 2009	EQ 125MG VALPROIC ACID, EQ 250MG VALPROIC ACID, EQ 500MG VALPROIC ACID
PRINSTON PHARMACEUTICAL INC	090210	AB (A-rated, therapeutically equivalent)	November 30, 2009	EQ 125MG VALPROIC ACID, EQ 250MG VALPROIC ACID, EQ 500MG VALPROIC ACID
UNICHEM LABORATORIES LIMITED	079163	AB (A-rated, therapeutically equivalent)	April 5, 2011	EQ 125MG VALPROIC ACID, EQ 250MG VALPROIC ACID, EQ 500MG VALPROIC ACID
AUROBINDO PHARMA LIMITED	090554	AB (A-rated, therapeutically equivalent)	April 21, 2011	EQ 125MG VALPROIC ACID, EQ 250MG VALPROIC ACID, EQ 500MG VALPROIC ACID
AJANTA PHARMA LTD	213181	AB (A-rated, therapeutically equivalent)	March 2, 2020	EQ 125MG VALPROIC ACID
ALEMBIC PHARMACEUTICALS LTD	218793	AB (A-rated, therapeutically equivalent)	December 19, 2024	EQ 125MG VALPROIC ACID
MANKIND PHARMA LTD	217358	AB (A-rated, therapeutically equivalent)	August 12, 2025	EQ 125MG VALPROIC ACID

Depakote NDC codes

Questions

Is there a generic for Depakote?

Yes. The generic name for Depakote is divalproex. 13 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 Depakote?

The active ingredient in Depakote is divalproex, 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.