FDA Orange Book

Generic for Fareston

Fareston contains toremifene. 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 Fareston is toremifene. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Fareston products in the Orange Book

Fareston products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, oralEQ 60MG BASEDiscontinuedNone2AB

NDA 020497, held by KYOWA KIRIN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic toremifene

Approved generic versions of Fareston
CompanyANDATE codeApprovedStrengths
RISING PHARMA HOLDINGS INC208813AB (A-rated, therapeutically equivalent)December 4, 2018EQ 60MG BASE
MSN LABORATORIES PRIVATE LTD212818AB (A-rated, therapeutically equivalent)August 18, 2020EQ 60MG BASE

Fareston NDC codes

Questions

Is there a generic for Fareston?

Yes. The generic name for Fareston is toremifene. 2 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 Fareston?

The active ingredient in Fareston is toremifene, 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.

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