FDA Orange Book

Generic for Diovan

Diovan contains valsartan. 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 is valsartan. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 6 Diovan products the Orange Book lists.

Run it in Rivvi

Map Diovan and your other top fills to their generics

Every strength in RxNorm, with brands that have no generic flagged.

Build the map

Free to start. Opens Rivvi, the AI workspace for healthcare teams.

Diovan products in the Orange Book

Diovan products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, oral160MGDiscontinuedNone0None
capsule, oral80MGDiscontinuedNone0None
tablet, oral160MGMarketed (Rx)AB16AB
tablet, oral320MGMarketed (Rx)AB16AB
tablet, oral40MGMarketed (Rx)AB16AB
tablet, oral80MGMarketed (Rx)AB16AB

NDA 020665, 021283, 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

Approved generic versions of Diovan
CompanyANDATE codeApprovedStrengths
OHM LABORATORIES INC077492AB (A-rated, therapeutically equivalent)June 26, 2014160MG, 320MG, 40MG, 80MG
ALEMBIC PHARMACEUTICALS LTD091367AB (A-rated, therapeutically equivalent)January 5, 2015160MG, 320MG, 40MG, 80MG
AUROBINDO PHARMA LTD202223AB (A-rated, therapeutically equivalent)January 5, 2015160MG, 320MG, 40MG, 80MG
HETERO LABS LTD UNIT V203311AB (A-rated, therapeutically equivalent)January 5, 2015160MG, 320MG, 40MG, 80MG
JUBILANT GENERICS LTD203536AB (A-rated, therapeutically equivalent)January 5, 2015160MG, 320MG, 40MG, 80MG
MYLAN PHARMACEUTICALS INC090866AB (A-rated, therapeutically equivalent)January 5, 2015160MG, 320MG, 40MG, 80MG
PRINSTON PHARMACEUTICAL INC204821AB (A-rated, therapeutically equivalent)June 9, 2015160MG, 320MG, 40MG, 80MG
AMNEAL PHARMACEUTICALS OF NEW YORK LLC204011AB (A-rated, therapeutically equivalent)January 11, 2016160MG, 320MG, 40MG, 80MG
MACLEODS PHARMACEUTICALS LTD202696AB (A-rated, therapeutically equivalent)September 16, 2016160MG, 320MG, 40MG, 80MG
ADAPTIS PHARMA PRIVATE LTD205347AB (A-rated, therapeutically equivalent)April 9, 2018160MG, 320MG, 40MG, 80MG
ALKEM LABORATORIES LTD205536AB (A-rated, therapeutically equivalent)March 12, 2019160MG, 320MG, 40MG, 80MG
DR REDDYS LABORATORIES LTD201618AB (A-rated, therapeutically equivalent)October 5, 2021160MG, 320MG, 40MG, 80MG
SCIEGEN PHARMACEUTICALS INC204038AB (A-rated, therapeutically equivalent)October 27, 2021160MG, 320MG, 40MG, 80MG
ZYDUS LIFESCIENCES LTD218991AB (A-rated, therapeutically equivalent)July 22, 2024160MG, 320MG, 40MG, 80MG
PHARMOBEDIENT CONSULTING LLC218897AB (A-rated, therapeutically equivalent)April 21, 2026160MG, 320MG, 40MG, 80MG
BOSTAL DRUG DELIVERY CO LTD205357AB (A-rated, therapeutically equivalent)August 11, 2026160MG, 320MG, 40MG, 80MG

Diovan NDC codes

Questions

Is there a generic for Diovan?

Yes. The generic name for Diovan is valsartan. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 6 Diovan products the Orange Book lists.

What is the generic name for Diovan?

The active ingredient in Diovan is valsartan, 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.

More on Diovan and Valsartan

Try it on your own data today.

Free to start. Most teams are using it the same day.