FDA Orange Book
Generic for Proair HFA
Proair HFA contains albuterol. 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 Proair HFA is albuterol. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2, AB3.
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Proair HFA products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| aerosol, metered, inhalation | EQ 0.09MG BASE/INH | Marketed (Rx) | AB2 | 7 | AB2, AB1, AB3 |
NDA 021457, held by TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic albuterol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PADAGIS US LLC | 203760 | AB2 (A-rated, therapeutically equivalent) | February 24, 2020 | EQ 0.09MG BASE/INH |
| CIPLA LTD | 209959 | AB1 (A-rated, therapeutically equivalent) | April 8, 2020 | EQ 0.09MG BASE/INH |
| LUPIN INC | 209954 | AB2 (A-rated, therapeutically equivalent) | August 24, 2020 | EQ 0.09MG BASE/INH |
| SANDOZ INC | 207085 | AB1 (A-rated, therapeutically equivalent) | June 1, 2021 | EQ 0.09MG BASE/INH |
| ARMSTRONG PHARMACEUTICALS INC | 212447 | AB2 (A-rated, therapeutically equivalent) | May 21, 2024 | EQ 0.09MG BASE/INH |
| AMNEAL IRELAND LTD | 211600 | AB2 (A-rated, therapeutically equivalent) | December 1, 2025 | EQ 0.09MG BASE/INH |
| CIPLA LTD | 219409 | AB3 (A-rated, therapeutically equivalent) | April 22, 2026 | EQ 0.09MG BASE/INH |
Proair HFA NDC codes
Questions
Is there a generic for Proair HFA?
Yes. The generic name for Proair HFA is albuterol. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2, AB3.
What is the generic name for Proair HFA?
The active ingredient in Proair HFA is albuterol, 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.