FDA Orange Book
Generic for Accuneb
Accuneb 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 Accuneb is albuterol. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AN.
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Accuneb products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, inhalation | EQ 0.021% BASE | Discontinued | None | 4 | AN |
| solution, inhalation | EQ 0.042% BASE | Discontinued | None | 4 | AN |
NDA 020949, held by PHARMOBEDIENT CONSULTING LLC. 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 |
|---|---|---|---|---|
| NEPHRON PHARMACEUTICALS CORP | 076355 | AN (A-rated, therapeutically equivalent) | March 31, 2010 | EQ 0.021% BASE, EQ 0.042% BASE |
| LUOXIN AUROVITAS PHARMA CHENGDU CO LTD | 211888 | AN (A-rated, therapeutically equivalent) | April 20, 2020 | EQ 0.021% BASE, EQ 0.042% BASE |
| THE RITEDOSE CORP | 214531 | AN (A-rated, therapeutically equivalent) | December 28, 2021 | EQ 0.021% BASE, EQ 0.042% BASE |
| LEXENPHARM SUZHOU LTD | 215571 | AN (A-rated, therapeutically equivalent) | May 3, 2024 | EQ 0.021% BASE, EQ 0.042% BASE |
Questions
Is there a generic for Accuneb?
Yes. The generic name for Accuneb is albuterol. 4 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 Accuneb?
The active ingredient in Accuneb 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.