FDA Orange Book
Generic for Demadex
Demadex contains torsemide. 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 Demadex is torsemide. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 6 Demadex products the Orange Book lists.
Run it in Rivvi
Map Demadex and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Demadex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 20MG/2ML (10MG/ML) | Discontinued | None | 0 | None |
| solution, intravenous | 50MG/5ML (10MG/ML) | Discontinued | None | 0 | None |
| tablet, oral | 100MG | Discontinued | None | 4 | AB |
| tablet, oral | 10MG | Discontinued | None | 5 | AB |
| tablet, oral | 20MG | Discontinued | None | 6 | AB |
| tablet, oral | 5MG | Discontinued | None | 5 | AB |
NDA 020137, 020136, held by HOFFMANN LA ROCHE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic torsemide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PLIVA PHARMACEUTICAL INDUSTRY INC | 076346 | AB (A-rated, therapeutically equivalent) | October 19, 2004 | 100MG, 10MG, 20MG, 5MG |
| HIKMA PHARMACEUTICALS USA INC | 076943 | AB (A-rated, therapeutically equivalent) | March 1, 2005 | 20MG |
| HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC | 076894 | AB (A-rated, therapeutically equivalent) | May 31, 2005 | 100MG, 10MG, 20MG, 5MG |
| AUROBINDO PHARMA LTD | 078249 | AB (A-rated, therapeutically equivalent) | October 17, 2007 | 100MG, 10MG, 20MG, 5MG |
| HETERO LABS LTD UNIT III | 079234 | AB (A-rated, therapeutically equivalent) | January 27, 2009 | 100MG, 10MG, 20MG, 5MG |
| MICRO LABS LTD | 217239 | AB (A-rated, therapeutically equivalent) | May 1, 2026 | 10MG, 20MG, 5MG |
Questions
Is there a generic for Demadex?
Yes. The generic name for Demadex is torsemide. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 6 Demadex products the Orange Book lists.
What is the generic name for Demadex?
The active ingredient in Demadex is torsemide, 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.