FDA Orange Book

Generic for Meclomen

Meclomen contains meclofenamate. 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 Meclomen is meclofenamate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.

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Meclomen products in the Orange Book

Meclomen products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, oralEQ 100MG BASEDiscontinuedNone1None
capsule, oralEQ 50MG BASEDiscontinuedNone1None

NDA 018006, held by PARKE DAVIS DIV WARNER LAMBERT CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic meclofenamate

Approved generic versions of Meclomen
CompanyANDATE codeApprovedStrengths
MYLAN PHARMACEUTICALS INC071081None (No TE code listed)September 3, 1986EQ 100MG BASE, EQ 50MG BASE

Questions

Is there a generic for Meclomen?

Yes. The generic name for Meclomen is meclofenamate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.

What is the generic name for Meclomen?

The active ingredient in Meclomen is meclofenamate, 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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