FDA Orange Book
Generic for Tiocystin
Tiocystin contains tiopronin. 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 Tiocystin is tiopronin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Tiocystin products the Orange Book lists.
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Tiocystin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Marketed (Rx) | None | 1 | AB |
| tablet, oral | 200MG | Marketed (Rx) | None | 0 | None |
NDA 212927, held by CASPER PHARMA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tiopronin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 214326 | AB (A-rated, therapeutically equivalent) | April 26, 2021 | 100MG |
Questions
Is there a generic for Tiocystin?
Yes. The generic name for Tiocystin is tiopronin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Tiocystin products the Orange Book lists.
What is the generic name for Tiocystin?
The active ingredient in Tiocystin is tiopronin, 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.