FDA Orange Book
Generic for Xopenex
Xopenex contains levalbuterol. 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 Xopenex is levalbuterol. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AN.
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Xopenex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, inhalation | EQ 0.0103% BASE | Discontinued | None | 5 | AN |
| solution, inhalation | EQ 0.021% BASE | Discontinued | None | 6 | AN |
| solution, inhalation | EQ 0.042% BASE | Discontinued | None | 6 | AN |
| solution, inhalation | EQ 0.25% BASE | Discontinued | None | 3 | AN |
NDA 020837, held by HIKMA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic levalbuterol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| IMPAX LABORATORIES INC | 077756 | AN (A-rated, therapeutically equivalent) | April 9, 2008 | EQ 0.0103% BASE, EQ 0.021% BASE, EQ 0.042% BASE |
| MYLAN SPECIALTY LP | 078309 | AN (A-rated, therapeutically equivalent) | March 20, 2009 | EQ 0.25% BASE |
| TEVA PHARMACEUTICALS USA | 090297 | AN (A-rated, therapeutically equivalent) | April 26, 2013 | EQ 0.0103% BASE, EQ 0.021% BASE, EQ 0.042% BASE |
| CIPLA LTD | 078171 | AN (A-rated, therapeutically equivalent) | December 13, 2013 | EQ 0.0103% BASE, EQ 0.021% BASE, EQ 0.042% BASE |
| TEVA PARENTERAL MEDICINES INC | 200875 | AN (A-rated, therapeutically equivalent) | September 11, 2014 | EQ 0.25% BASE |
| THE RITEDOSE CORP | 203653 | AN (A-rated, therapeutically equivalent) | March 22, 2016 | EQ 0.0103% BASE, EQ 0.021% BASE, EQ 0.042% BASE |
| LUOXIN AUROVITAS PHARMA CHENGDU CO LTD | 207625 | AN (A-rated, therapeutically equivalent) | December 30, 2016 | EQ 0.0103% BASE, EQ 0.021% BASE, EQ 0.042% BASE |
| LUOXIN AUROVITAS PHARMA CHENGDU CO LTD | 207628 | AN (A-rated, therapeutically equivalent) | January 31, 2017 | EQ 0.25% BASE |
| NEPHRON PHARMACEUTICALS CORPORATION | 215217 | AN (A-rated, therapeutically equivalent) | May 26, 2026 | EQ 0.021% BASE, EQ 0.042% BASE |
Questions
Is there a generic for Xopenex?
Yes. The generic name for Xopenex is levalbuterol. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AN.
What is the generic name for Xopenex?
The active ingredient in Xopenex is levalbuterol, 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.