FDA Orange Book
Generic for Ponstel
Ponstel contains mefenamic acid. 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 Ponstel is mefenamic acid. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Ponstel products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 250MG | Marketed (Rx) | AB | 3 | AB |
NDA 015034, held by AVION PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic mefenamic acid
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MICRO LABS LTD | 090562 | AB (A-rated, therapeutically equivalent) | November 19, 2010 | 250MG |
| LUPIN LTD | 091322 | AB (A-rated, therapeutically equivalent) | July 22, 2011 | 250MG |
| AJENAT PHARMACEUTICALS LLC | 091608 | AB (A-rated, therapeutically equivalent) | June 2, 2014 | 250MG |
Questions
Is there a generic for Ponstel?
Yes. The generic name for Ponstel is mefenamic acid. 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 Ponstel?
The active ingredient in Ponstel is mefenamic acid, 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.