FDA Orange Book
Generic for Glyset
Glyset contains miglitol. 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 Glyset is miglitol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
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Glyset products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Discontinued | None | 1 | None |
| tablet, oral | 25MG | Discontinued | None | 1 | None |
| tablet, oral | 50MG | Discontinued | None | 1 | None |
NDA 020682, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic miglitol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ORIENT PHARMA CO LTD | 203965 | None (No TE code listed) | February 24, 2015 | 100MG, 25MG, 50MG |
Questions
Is there a generic for Glyset?
Yes. The generic name for Glyset is miglitol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
What is the generic name for Glyset?
The active ingredient in Glyset is miglitol, 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.