FDA Orange Book

Generic for Diovan HCT

Diovan HCT contains valsartan and hydrochlorothiazide. 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 Diovan HCT is valsartan and hydrochlorothiazide. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Diovan HCT products in the Orange Book

Diovan HCT products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	12.5MG;160MG	Marketed (Rx)	AB	7	AB
tablet, oral	12.5MG;320MG	Marketed (Rx)	AB	7	AB
tablet, oral	12.5MG;80MG	Marketed (Rx)	AB	7	AB
tablet, oral	25MG;160MG	Marketed (Rx)	AB	7	AB
tablet, oral	25MG;320MG	Marketed (Rx)	AB	7	AB

NDA 020818, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic valsartan and hydrochlorothiazide

Approved generic versions of Diovan HCT
Company	ANDA	TE code	Approved	Strengths
MYLAN PHARMACEUTICALS INC	078020	AB (A-rated, therapeutically equivalent)	September 21, 2012	12.5MG;160MG, 12.5MG;320MG, 12.5MG;80MG, 25MG;160MG, 25MG;320MG
ALEMBIC PHARMACEUTICALS LTD	201662	AB (A-rated, therapeutically equivalent)	March 21, 2013	12.5MG;160MG, 12.5MG;320MG, 12.5MG;80MG, 25MG;160MG, 25MG;320MG
AUROBINDO PHARMA LTD	202519	AB (A-rated, therapeutically equivalent)	March 21, 2013	12.5MG;160MG, 12.5MG;320MG, 12.5MG;80MG, 25MG;160MG, 25MG;320MG
MACLEODS PHARMACEUTICALS LTD	203145	AB (A-rated, therapeutically equivalent)	April 19, 2013	12.5MG;160MG, 12.5MG;320MG, 12.5MG;80MG, 25MG;160MG, 25MG;320MG
PRINSTON PHARMACEUTICAL INC	206083	AB (A-rated, therapeutically equivalent)	February 8, 2016	12.5MG;160MG, 12.5MG;320MG, 12.5MG;80MG, 25MG;160MG, 25MG;320MG
AMNEAL PHARMACEUTICALS OF NEW YORK LLC	204382	AB (A-rated, therapeutically equivalent)	August 11, 2023	12.5MG;160MG, 12.5MG;320MG, 12.5MG;80MG, 25MG;160MG, 25MG;320MG
SCIEGEN PHARMACEUTICALS INC	204687	AB (A-rated, therapeutically equivalent)	April 23, 2026	12.5MG;160MG, 12.5MG;320MG, 12.5MG;80MG, 25MG;160MG, 25MG;320MG

Diovan HCT NDC codes

Questions

Is there a generic for Diovan HCT?

Yes. The generic name for Diovan HCT is valsartan and hydrochlorothiazide. 7 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 Diovan HCT?

The active ingredient in Diovan HCT is valsartan and hydrochlorothiazide, 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.