FDA Orange Book
Generic for Lioresal
Lioresal contains baclofen. 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 Lioresal is baclofen. 17 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
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Lioresal products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, intrathecal | 0.05MG/ML | Marketed (Rx) | AP | 2 | AP |
| injectable, intrathecal | 0.5MG/ML | Marketed (Rx) | AP | 3 | AP |
| injectable, intrathecal | 2MG/ML | Marketed (Rx) | AP | 3 | AP |
| tablet, oral | 10MG | Discontinued | None | 16 | AB |
| tablet, oral | 20MG | Discontinued | None | 16 | AB |
NDA 020075, 017851, held by AMNEAL PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic baclofen
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA | 072234 | AB (A-rated, therapeutically equivalent) | July 21, 1988 | 10MG |
| IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA | 072235 | AB (A-rated, therapeutically equivalent) | July 21, 1988 | 20MG |
| PHARMOBEDIENT CONSULTING LLC | 074584 | AB (A-rated, therapeutically equivalent) | August 19, 1996 | 10MG, 20MG |
| PH HEALTH LTD | 077068 | AB (A-rated, therapeutically equivalent) | August 30, 2005 | 10MG, 20MG |
| LANNETT CO INC | 077241 | AB (A-rated, therapeutically equivalent) | July 6, 2007 | 10MG, 20MG |
| TP ANDA HOLDINGS LLC | 077088 | AB (A-rated, therapeutically equivalent) | October 31, 2007 | 10MG, 20MG |
| NORTHSTAR HEALTHCARE HOLDINGS LTD | 078401 | AB (A-rated, therapeutically equivalent) | September 18, 2009 | 10MG, 20MG |
| AMNEAL PHARMACEUTICALS LLC | 091193 | AP (A-rated, therapeutically equivalent) | May 3, 2016 | 0.05MG/ML, 0.5MG/ML, 2MG/ML |
| RUBICON RESEARCH LTD | 209102 | AB (A-rated, therapeutically equivalent) | November 28, 2017 | 10MG, 20MG |
| ZYDUS LIFESCIENCES GLOBAL FZE | 211659 | AB (A-rated, therapeutically equivalent) | November 23, 2018 | 10MG, 20MG |
| ADAPTIS PHARMA PRIVATE LTD | 211555 | AB (A-rated, therapeutically equivalent) | February 1, 2019 | 10MG, 20MG |
| UNICHEM LABORATORIES LTD | 212067 | AB (A-rated, therapeutically equivalent) | July 9, 2020 | 10MG, 20MG |
| ANDAS 5 HOLDING LLC | 212378 | AB (A-rated, therapeutically equivalent) | October 9, 2020 | 10MG, 20MG |
| MAIA PHARMACEUTICALS INC | 210048 | AP (A-rated, therapeutically equivalent) | January 15, 2021 | 0.05MG/ML, 0.5MG/ML, 2MG/ML |
| RISING PHARMA HOLDINGS INC | 214374 | AB (A-rated, therapeutically equivalent) | March 5, 2021 | 10MG, 20MG |
| AUROBINDO PHARMA LTD | 214099 | AB (A-rated, therapeutically equivalent) | July 13, 2021 | 10MG, 20MG |
| REGCON HOLDINGS LLC | 214114 | AB (A-rated, therapeutically equivalent) | July 16, 2021 | 10MG, 20MG |
| MANKIND PHARMA LTD | 215885 | AB (A-rated, therapeutically equivalent) | January 25, 2022 | 10MG, 20MG |
| RUBICON RESEARCH LTD | 217324 | AP (A-rated, therapeutically equivalent) | February 22, 2023 | 0.5MG/ML, 2MG/ML |
| RISING PHARMA HOLDINGS INC | 217788 | AB (A-rated, therapeutically equivalent) | January 10, 2024 | 10MG, 20MG |
Lioresal NDC codes
Questions
Is there a generic for Lioresal?
Yes. The generic name for Lioresal is baclofen. 17 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
What is the generic name for Lioresal?
The active ingredient in Lioresal is baclofen, 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.