FDA Orange Book

Generic for Antabuse

Antabuse contains disulfiram. 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 Antabuse is disulfiram. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Antabuse products in the Orange Book

Antabuse products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, oral250MGDiscontinuedNone3AB
tablet, oral500MGDiscontinuedNone2AB

NDA 007883, held by TEVA WOMENS HEALTH INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic disulfiram

Approved generic versions of Antabuse
CompanyANDATE codeApprovedStrengths
SIGMAPHARM LABORATORIES LLC091619AB (A-rated, therapeutically equivalent)March 28, 2011250MG, 500MG
CHARTWELL MOLECULES LLC091563AB (A-rated, therapeutically equivalent)December 31, 2012250MG, 500MG
ALVOGEN INC091681AB (A-rated, therapeutically equivalent)August 8, 2013250MG

Questions

Is there a generic for Antabuse?

Yes. The generic name for Antabuse is disulfiram. 3 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 Antabuse?

The active ingredient in Antabuse is disulfiram, 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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