FDA Orange Book
Generic for Edecrin
Edecrin contains ethacrynate. 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 Edecrin is ethacrynate. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 2 of the 3 Edecrin products the Orange Book lists.
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Edecrin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 50MG BASE/VIAL | Marketed (Rx) | AP | 3 | AP |
| tablet, oral | 25MG | Marketed (Rx) | AB | 7 | AB |
| tablet, oral | 50MG | Discontinued | None | 0 | None |
NDA 016093, 016092, held by BAUSCH HEALTH AMERICAS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ethacrynate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PH HEALTH LTD | 205473 | AP (A-rated, therapeutically equivalent) | July 29, 2015 | EQ 50MG BASE/VIAL |
| ADAPTIS PHARMA PRIVATE LTD | 205609 | AB (A-rated, therapeutically equivalent) | June 30, 2016 | 25MG |
| ZYDUS PHARMACEUTICALS USA INC | 207758 | AP (A-rated, therapeutically equivalent) | November 17, 2017 | EQ 50MG BASE/VIAL |
| AMNEAL PHARMACEUTICALS CO GMBH | 208805 | AB (A-rated, therapeutically equivalent) | May 8, 2018 | 25MG |
| AGNITIO INC | 211809 | AB (A-rated, therapeutically equivalent) | July 12, 2019 | 25MG |
| SCIEGEN PHARMACEUTICALS INC | 211232 | AB (A-rated, therapeutically equivalent) | August 27, 2019 | 25MG |
| LUPIN LTD | 211719 | AB (A-rated, therapeutically equivalent) | September 6, 2019 | 25MG |
| UPSHER SMITH LABORATORIES LLC | 212417 | AB (A-rated, therapeutically equivalent) | February 19, 2020 | 25MG |
| STERIMAX INC | 208663 | AP (A-rated, therapeutically equivalent) | June 9, 2020 | EQ 50MG BASE/VIAL |
| CHARTWELL RX SCIENCES LLC | 213240 | AB (A-rated, therapeutically equivalent) | October 19, 2020 | 25MG |
Edecrin NDC codes
Questions
Is there a generic for Edecrin?
Yes. The generic name for Edecrin is ethacrynate. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 2 of the 3 Edecrin products the Orange Book lists.
What is the generic name for Edecrin?
The active ingredient in Edecrin is ethacrynate, 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.