FDA Orange Book
Generic for Lysteda
Lysteda contains tranexamic acid. 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 Lysteda is tranexamic acid. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Lysteda products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 650MG | Marketed (Rx) | AB | 6 | AB |
NDA 022430, held by J MOLNER HOLDINGS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tranexamic acid
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS LABORATORIES FL INC | 202093 | AB (A-rated, therapeutically equivalent) | December 27, 2012 | 650MG |
| AUROBINDO PHARMA USA INC | 205133 | AB (A-rated, therapeutically equivalent) | September 21, 2015 | 650MG |
| ANI PHARMACEUTICALS INC | 203256 | AB (A-rated, therapeutically equivalent) | July 25, 2016 | 650MG |
| RUBICON RESEARCH LTD | 218320 | AB (A-rated, therapeutically equivalent) | June 11, 2024 | 650MG |
| APPCO PHARMA LLC | 218729 | AB (A-rated, therapeutically equivalent) | June 11, 2025 | 650MG |
| PHARMAZONE | 219702 | AB (A-rated, therapeutically equivalent) | January 26, 2026 | 650MG |
Lysteda NDC codes
Questions
Is there a generic for Lysteda?
Yes. The generic name for Lysteda is tranexamic acid. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Lysteda?
The active ingredient in Lysteda is tranexamic acid, 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.