FDA Orange Book

Generic for Didrex

Didrex contains benzphetamine. 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 Didrex is benzphetamine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.

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Didrex products in the Orange Book

Didrex products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, oral25MGDiscontinuedNone1None
tablet, oral50MGDiscontinuedNone4AA

NDA 012427, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic benzphetamine

Approved generic versions of Didrex
CompanyANDATE codeApprovedStrengths
KVK TECH INC090968AA (A-rated, therapeutically equivalent)July 20, 201050MG
CHARTWELL SCHEDULED LLC090473None (No TE code listed)September 15, 201025MG, 50MG
AVET LIFESCIENCES LTD202061AA (A-rated, therapeutically equivalent)January 27, 201250MG
EPIC PHARMA LLC090346AA (A-rated, therapeutically equivalent)December 15, 201550MG

Questions

Is there a generic for Didrex?

Yes. The generic name for Didrex is benzphetamine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.

What is the generic name for Didrex?

The active ingredient in Didrex is benzphetamine, 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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