FDA Orange Book
Generic for Orudis
Orudis contains ketoprofen. 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 Orudis is ketoprofen. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Orudis products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 25MG | Discontinued | None | 1 | None |
| capsule, oral | 50MG | Discontinued | None | 2 | AB |
| capsule, oral | 75MG | Discontinued | None | 1 | None |
NDA 018754, held by WYETH AYERST LABORATORIES. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ketoprofen
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 073516 | AB (A-rated, therapeutically equivalent) | December 22, 1992 | 50MG |
| MISEMER PHARMACEUTICALS INC | 074014 | None (No TE code listed) | January 29, 1993 | 25MG, 50MG, 75MG |
Questions
Is there a generic for Orudis?
Yes. The generic name for Orudis is ketoprofen. 2 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 Orudis?
The active ingredient in Orudis is ketoprofen, 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.