FDA Orange Book
Generic for Zemuron
Zemuron contains rocuronium bromide. 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 Zemuron is rocuronium bromide. 18 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 Zemuron products the Orange Book lists.
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Zemuron products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 100MG/10ML (10MG/ML) | Discontinued | None | 17 | AP |
| injectable, injection | 10MG/ML (10MG/ML) | Discontinued | None | 0 | None |
| injectable, injection | 50MG/5ML (10MG/ML) | Discontinued | None | 18 | AP |
NDA 020214, held by ORGANON USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic rocuronium bromide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HOSPIRA INC | 078519 | AP (A-rated, therapeutically equivalent) | November 26, 2008 | 100MG/10ML (10MG/ML), 50MG/5ML (10MG/ML) |
| MYLAN INSTITUTIONAL LLC | 079199 | AP (A-rated, therapeutically equivalent) | November 26, 2008 | 100MG/10ML (10MG/ML), 50MG/5ML (10MG/ML) |
| SANDOZ INC | 079195 | AP (A-rated, therapeutically equivalent) | December 5, 2008 | 100MG/10ML (10MG/ML), 50MG/5ML (10MG/ML) |
| FRESENIUS KABI USA LLC | 078651 | AP (A-rated, therapeutically equivalent) | December 29, 2008 | 100MG/10ML (10MG/ML), 50MG/5ML (10MG/ML) |
| SAGENT PHARMACEUTICALS INC | 091458 | AP (A-rated, therapeutically equivalent) | July 28, 2010 | 100MG/10ML (10MG/ML), 50MG/5ML (10MG/ML) |
| TAMARANG SA | 091115 | AP (A-rated, therapeutically equivalent) | August 27, 2012 | 100MG/10ML (10MG/ML), 50MG/5ML (10MG/ML) |
| WEST WARD PHARMACEUTICAL CORP | 204679 | AP (A-rated, therapeutically equivalent) | February 28, 2017 | 100MG/10ML (10MG/ML), 50MG/5ML (10MG/ML) |
| EUGIA PHARMA SPECIALITIES LTD | 206206 | AP (A-rated, therapeutically equivalent) | April 12, 2017 | 100MG/10ML (10MG/ML), 50MG/5ML (10MG/ML) |
| GLAND PHARMA LTD | 205656 | AP (A-rated, therapeutically equivalent) | April 4, 2018 | 100MG/10ML (10MG/ML), 50MG/5ML (10MG/ML) |
| PIRAMAL CRITICAL CARE INC | 210437 | AP (A-rated, therapeutically equivalent) | August 13, 2019 | 100MG/10ML (10MG/ML), 50MG/5ML (10MG/ML) |
| PRINSTON PHARMACEUTICAL INC | 212668 | AP (A-rated, therapeutically equivalent) | May 26, 2022 | 100MG/10ML (10MG/ML), 50MG/5ML (10MG/ML) |
| CAPLIN STERILES LTD | 216234 | AP (A-rated, therapeutically equivalent) | March 2, 2023 | 100MG/10ML (10MG/ML), 50MG/5ML (10MG/ML) |
| MEITHEAL PHARMACEUTICALS INC | 213453 | AP (A-rated, therapeutically equivalent) | May 8, 2023 | 100MG/10ML (10MG/ML), 50MG/5ML (10MG/ML) |
| SHANDONG NEW TIME PHARMACEUTICAL CO LTD | 215684 | AP (A-rated, therapeutically equivalent) | July 12, 2024 | 100MG/10ML (10MG/ML), 50MG/5ML (10MG/ML) |
| STERISCIENCE PTE LTD | 217092 | AP (A-rated, therapeutically equivalent) | July 22, 2024 | 50MG/5ML (10MG/ML) |
| MANKIND PHARMA LTD | 219674 | AP (A-rated, therapeutically equivalent) | May 29, 2025 | 100MG/10ML (10MG/ML), 50MG/5ML (10MG/ML) |
| ASPIRO PHARMA LTD | 220124 | AP (A-rated, therapeutically equivalent) | March 4, 2026 | 100MG/10ML (10MG/ML), 50MG/5ML (10MG/ML) |
| BAXTER HEALTHCARE CORP | 219260 | AP (A-rated, therapeutically equivalent) | September 18, 2026 | 100MG/10ML (10MG/ML), 50MG/5ML (10MG/ML) |
Questions
Is there a generic for Zemuron?
Yes. The generic name for Zemuron is rocuronium bromide. 18 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 Zemuron products the Orange Book lists.
What is the generic name for Zemuron?
The active ingredient in Zemuron is rocuronium bromide, 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.