FDA Orange Book

Generic for Purixan

Purixan contains mercaptopurine. 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 Purixan is mercaptopurine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Purixan products in the Orange Book

Purixan products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
suspension, oral20MG/MLMarketed (Rx)AB1AB

NDA 205919, held by NOVA LABORATORIES LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic mercaptopurine

Approved generic versions of Purixan
CompanyANDATE codeApprovedStrengths
HIKMA PHARMACEUTICALS USA INC216418AB (A-rated, therapeutically equivalent)February 26, 202520MG/ML

Purixan NDC codes

Questions

Is there a generic for Purixan?

Yes. The generic name for Purixan is mercaptopurine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Purixan?

The active ingredient in Purixan is mercaptopurine, 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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