FDA Orange Book
Generic for Relafen
Relafen contains nabumetone. 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 Relafen is nabumetone. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Relafen products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 500MG | Discontinued | None | 8 | AB |
| tablet, oral | 750MG | Discontinued | None | 8 | AB |
NDA 019583, held by SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic nabumetone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CHARTWELL RX SCIENCES LLC | 075280 | AB (A-rated, therapeutically equivalent) | February 25, 2002 | 500MG, 750MG |
| CHARTWELL MOLECULES LLC | 076009 | AB (A-rated, therapeutically equivalent) | January 24, 2003 | 500MG, 750MG |
| INVAGEN PHARMACEUTICALS INC | 078671 | AB (A-rated, therapeutically equivalent) | March 7, 2008 | 500MG, 750MG |
| SCIEGEN PHARMACEUTICALS INC | 078420 | AB (A-rated, therapeutically equivalent) | September 24, 2008 | 500MG, 750MG |
| ANNORA PHARMA PRIVATE LTD | 090445 | AB (A-rated, therapeutically equivalent) | January 12, 2011 | 500MG, 750MG |
| WATSON LABORATORIES INC | 091083 | AB (A-rated, therapeutically equivalent) | June 13, 2011 | 500MG, 750MG |
| LGM PHARMA SOLUTIONS LLC | 203166 | AB (A-rated, therapeutically equivalent) | August 30, 2019 | 500MG, 750MG |
| NOVITIUM PHARMA LLC | 219118 | AB (A-rated, therapeutically equivalent) | January 7, 2025 | 500MG, 750MG |
Questions
Is there a generic for Relafen?
Yes. The generic name for Relafen is nabumetone. 8 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 Relafen?
The active ingredient in Relafen is nabumetone, 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.