FDA Orange Book
Generic for Brevibloc
Brevibloc contains esmolol. 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 Brevibloc is esmolol. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 3 Brevibloc products the Orange Book lists.
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Brevibloc products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 10MG/ML | Marketed (Rx) | AP | 4 | AP |
| injectable, injection | 10MG/ML | Discontinued | None | 4 | AP |
| injectable, injection | 20MG/ML | Discontinued | None | 0 | None |
NDA 019386, held by BAXTER HEALTHCARE CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic esmolol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 076323 | AP (A-rated, therapeutically equivalent) | August 10, 2004 | 10MG/ML, 10MG/ML |
| MYLAN INSTITUTIONAL LLC | 076474 | AP (A-rated, therapeutically equivalent) | May 2, 2005 | 10MG/ML, 10MG/ML |
| EUGIA PHARMA SPECIALITIES LTD | 205520 | AP (A-rated, therapeutically equivalent) | July 23, 2015 | 10MG/ML, 10MG/ML |
| GLAND PHARMA LTD | 208538 | AP (A-rated, therapeutically equivalent) | August 14, 2019 | 10MG/ML, 10MG/ML |
Brevibloc NDC codes
Questions
Is there a generic for Brevibloc?
Yes. The generic name for Brevibloc is esmolol. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 3 Brevibloc products the Orange Book lists.
What is the generic name for Brevibloc?
The active ingredient in Brevibloc is esmolol, 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.