FDA Orange Book
Generic for Duoneb
Duoneb contains ipratropium bromide and 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 Duoneb is ipratropium bromide and 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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Duoneb products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, inhalation | EQ 0.083% BASE;0.017% | Discontinued | None | 4 | AN |
NDA 020950, 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 ipratropium bromide and albuterol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CIPLA LTD | 077559 | AN (A-rated, therapeutically equivalent) | December 31, 2007 | EQ 0.083% BASE;0.017% |
| NEPHRON PHARMACEUTICALS CORP | 076749 | AN (A-rated, therapeutically equivalent) | December 31, 2007 | EQ 0.083% BASE;0.017% |
| THE RITEDOSE CORP | 202496 | AN (A-rated, therapeutically equivalent) | October 1, 2012 | EQ 0.083% BASE;0.017% |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 207875 | AN (A-rated, therapeutically equivalent) | August 7, 2017 | EQ 0.083% BASE;0.017% |
Questions
Is there a generic for Duoneb?
Yes. The generic name for Duoneb is ipratropium bromide and 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 Duoneb?
The active ingredient in Duoneb is ipratropium bromide and 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.