FDA Orange Book

Is there a generic for Matulane?

Matulane contains procarbazine. 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

No. The Orange Book lists no active FDA-approved generic (ANDA) for Matulane (procarbazine).

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Matulane products in the Orange Book

Matulane products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, oralEQ 50MG BASEMarketed (Rx)None0None

NDA 016785, held by LEADIANT BIOSCIENCES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Matulane NDC codes

Questions

Is there a generic for Matulane?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Matulane (procarbazine).

What is the generic name for Matulane?

The active ingredient in Matulane is procarbazine, 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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