FDA Orange Book
Is there a generic for Xopenex HFA?
Xopenex HFA 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xopenex HFA (levalbuterol).
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Xopenex HFA products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| aerosol, metered, inhalation | EQ 0.045MG BASE/INH | Marketed (Rx) | None | 0 | None |
NDA 021730, held by LUPIN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Xopenex HFA NDC codes
Questions
Is there a generic for Xopenex HFA?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xopenex HFA (levalbuterol).
What is the generic name for Xopenex HFA?
The active ingredient in Xopenex HFA 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.
More on Xopenex HFA and Levalbuterol
- What is Xopenex HFA used for?FDA label uses
- Is Xopenex HFA a controlled substance?Federal schedule
- What is Levalbuterol used for?FDA label uses
- Is Levalbuterol a controlled substance?Federal schedule
- Generic for XopenexFDA Orange Book
- Beta2-Adrenergic Agonists listFDA drug class
- NDC 27437-056Xopenex HFA NDC record