FDA Orange Book
Generic for Lodine
Lodine 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 is etodolac. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Lodine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 200MG | Discontinued | None | 4 | AB |
| capsule, oral | 300MG | Discontinued | None | 4 | AB |
| tablet, oral | 400MG | Discontinued | None | 7 | AB |
| tablet, oral | 500MG | Discontinued | None | 7 | AB |
NDA 018922, 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 |
|---|---|---|---|---|
| PANGEA PHARMACEUTICALS LLC | 074903 | AB (A-rated, therapeutically equivalent) | April 11, 1997 | 400MG, 500MG |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 075074 | AB (A-rated, therapeutically equivalent) | March 11, 1998 | 400MG, 500MG |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 075078 | AB (A-rated, therapeutically equivalent) | April 30, 1998 | 200MG, 300MG |
| ANI PHARMACEUTICALS INC | 075126 | AB (A-rated, therapeutically equivalent) | September 16, 1999 | 200MG, 300MG |
| APOTEX INC | 075419 | AB (A-rated, therapeutically equivalent) | July 28, 2000 | 200MG, 300MG |
| APOTEX INC | 076004 | AB (A-rated, therapeutically equivalent) | December 3, 2002 | 400MG, 500MG |
| AMNEAL PHARMACEUTICALS CO GMBH | 208834 | AB (A-rated, therapeutically equivalent) | June 7, 2018 | 400MG, 500MG |
| ADAPTIS PHARMA PRIVATE LTD | 209888 | AB (A-rated, therapeutically equivalent) | November 30, 2018 | 400MG, 500MG |
| IPCA LABORATORIES LTD | 204729 | AB (A-rated, therapeutically equivalent) | May 1, 2024 | 400MG, 500MG |
| IPCA LABORATORIES LTD | 205448 | AB (A-rated, therapeutically equivalent) | August 1, 2024 | 200MG, 300MG |
| AUROBINDO PHARMA LTD | 214872 | AB (A-rated, therapeutically equivalent) | July 15, 2026 | 400MG, 500MG |
Questions
Is there a generic for Lodine?
Yes. The generic name for Lodine is etodolac. 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 Lodine?
The active ingredient in Lodine 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.