FDA Orange Book
Generic for Ventolin HFA
Ventolin 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 Ventolin 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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Ventolin 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) | AB3 | 7 | AB2, AB1, AB3 |
NDA 020983, held by GLAXOSMITHKLINE INTELLECTUAL PROPERTY LTD ENGLAND. 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 |
Ventolin HFA NDC codes
Questions
Is there a generic for Ventolin HFA?
Yes. The generic name for Ventolin 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 Ventolin HFA?
The active ingredient in Ventolin 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.
More on Ventolin HFA and Albuterol
- What is Ventolin HFA used for?FDA label uses
- Is Ventolin HFA a controlled substance?Federal schedule
- What is Albuterol used for?FDA label uses
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