FDA Orange Book
Generic for Pletal
Pletal contains cilostazol. 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 Pletal is cilostazol. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Pletal products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Discontinued | None | 6 | AB |
| tablet, oral | 50MG | Discontinued | None | 6 | AB |
NDA 020863, held by OTSUKA PHARMACEUTICAL CO LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic cilostazol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA USA INC | 077019 | AB (A-rated, therapeutically equivalent) | November 23, 2004 | 100MG, 50MG |
| EPIC PHARMA LLC | 077022 | AB (A-rated, therapeutically equivalent) | November 23, 2004 | 100MG, 50MG |
| TEVA PHARMACEUTICALS USA INC | 077027 | AB (A-rated, therapeutically equivalent) | November 24, 2004 | 100MG, 50MG |
| APOTEX INC | 077030 | AB (A-rated, therapeutically equivalent) | December 10, 2004 | 100MG, 50MG |
| SLATE RUN PHARMACEUTICALS LLC | 077208 | AB (A-rated, therapeutically equivalent) | March 29, 2006 | 100MG, 50MG |
| CHARTWELL RX SCIENCES LLC | 077831 | AB (A-rated, therapeutically equivalent) | September 24, 2012 | 100MG, 50MG |
Questions
Is there a generic for Pletal?
Yes. The generic name for Pletal is cilostazol. 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 Pletal?
The active ingredient in Pletal is cilostazol, 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.