FDA Orange Book
Generic for Lodine XL
Lodine XL contains etodolac. 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 Lodine XL is etodolac. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Lodine XL and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Lodine XL products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 400MG | Discontinued | None | 4 | AB |
| tablet, extended release, oral | 500MG | Discontinued | None | 4 | AB |
| tablet, extended release, oral | 600MG | Discontinued | None | 4 | AB |
NDA 020584, held by WYETH PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic etodolac
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 075665 | AB (A-rated, therapeutically equivalent) | February 5, 2001 | 400MG, 500MG, 600MG |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 076174 | AB (A-rated, therapeutically equivalent) | March 13, 2003 | 400MG, 500MG, 600MG |
| ZYDUS PHARMACEUTICALS USA INC | 091134 | AB (A-rated, therapeutically equivalent) | January 23, 2014 | 400MG, 500MG, 600MG |
| UNICHEM LABORATORIES LTD | 212263 | AB (A-rated, therapeutically equivalent) | November 24, 2020 | 400MG, 500MG, 600MG |
Questions
Is there a generic for Lodine XL?
Yes. The generic name for Lodine XL is etodolac. 4 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 Lodine XL?
The active ingredient in Lodine XL is etodolac, 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.