FDA Orange Book
Generic for Bumex
Bumex contains bumetanide. 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 Bumex is bumetanide. 19 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
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Bumex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 0.25MG/ML | Discontinued | None | 8 | AP |
| tablet, oral | 0.5MG | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | 1MG | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | 2MG | Marketed (Rx) | AB | 12 | AB |
NDA 018226, 018225, held by VALIDUS PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic bumetanide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SAGENT PHARMACEUTICALS | 074441 | AP (A-rated, therapeutically equivalent) | January 27, 1995 | 0.25MG/ML |
| HERITAGE PHARMA LABS INC | 074225 | AB (A-rated, therapeutically equivalent) | April 24, 1995 | 0.5MG, 1MG, 2MG |
| SANDOZ INC | 074700 | AB (A-rated, therapeutically equivalent) | November 21, 1996 | 0.5MG, 1MG, 2MG |
| WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | 079196 | AP (A-rated, therapeutically equivalent) | April 30, 2008 | 0.25MG/ML |
| AMNEAL PHARMACEUTICALS CO GMBH | 209724 | AB (A-rated, therapeutically equivalent) | October 18, 2017 | 0.5MG, 1MG, 2MG |
| UPSHER SMITH LABORATORIES LLC | 209916 | AB (A-rated, therapeutically equivalent) | January 23, 2018 | 0.5MG, 1MG, 2MG |
| ZYDUS PHARMACEUTICALS USA INC | 202900 | AB (A-rated, therapeutically equivalent) | April 30, 2018 | 0.5MG, 1MG, 2MG |
| RISING PHARMA HOLDINGS INC | 212019 | AB (A-rated, therapeutically equivalent) | December 12, 2019 | 0.5MG, 1MG, 2MG |
| GLAND PHARMA LTD | 216434 | AP (A-rated, therapeutically equivalent) | May 26, 2022 | 0.25MG/ML |
| MSN LABORATORIES PRIVATE LTD | 215364 | AP (A-rated, therapeutically equivalent) | August 4, 2022 | 0.25MG/ML |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 213458 | AB (A-rated, therapeutically equivalent) | July 24, 2023 | 0.5MG, 1MG, 2MG |
| LUPIN LTD | 217153 | AP (A-rated, therapeutically equivalent) | September 17, 2024 | 0.25MG/ML |
| APPCO PHARMA LLC | 212931 | AB (A-rated, therapeutically equivalent) | September 18, 2024 | 0.5MG, 1MG, 2MG |
| QILU PHARMACEUTICAL HAINAN CO LTD | 219116 | AP (A-rated, therapeutically equivalent) | September 19, 2024 | 0.25MG/ML |
| RUBICON RESEARCH LTD | 213942 | AB (A-rated, therapeutically equivalent) | December 27, 2024 | 0.5MG, 1MG, 2MG |
| ASPIRO PHARMA LTD | 218746 | AP (A-rated, therapeutically equivalent) | February 27, 2025 | 0.25MG/ML |
| MANKIND PHARMA LTD | 219291 | AB (A-rated, therapeutically equivalent) | April 3, 2025 | 0.5MG, 1MG, 2MG |
| JUBILANT GENERICS LTD | 212470 | AB (A-rated, therapeutically equivalent) | August 5, 2025 | 0.5MG, 1MG, 2MG |
| MSN LABORATORIES PRIVATE LTD | 215362 | AB (A-rated, therapeutically equivalent) | February 5, 2026 | 0.5MG, 1MG, 2MG |
| ADAPTIS PHARMA PRIVATE LTD | 220427 | AP (A-rated, therapeutically equivalent) | February 26, 2026 | 0.25MG/ML |
Bumex NDC codes
Questions
Is there a generic for Bumex?
Yes. The generic name for Bumex is bumetanide. 19 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
What is the generic name for Bumex?
The active ingredient in Bumex is bumetanide, 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.