FDA Orange Book
Generic for Aricept ODT
Aricept ODT contains donepezil. 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 Aricept ODT is donepezil. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Aricept ODT products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, orally disintegrating, oral | 10MG | Discontinued | None | 2 | AB |
| tablet, orally disintegrating, oral | 5MG | Discontinued | None | 2 | AB |
NDA 021720, held by EISAI INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic donepezil
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MACLEODS PHARMACEUTICALS LTD | 201787 | AB (A-rated, therapeutically equivalent) | December 14, 2012 | 10MG, 5MG |
| HISUN PHARMACEUTICAL HANGZHOU CO LTD | 205269 | AB (A-rated, therapeutically equivalent) | July 27, 2018 | 10MG, 5MG |
Questions
Is there a generic for Aricept ODT?
Yes. The generic name for Aricept ODT is donepezil. 2 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 Aricept ODT?
The active ingredient in Aricept ODT is donepezil, 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.