FDA Orange Book
Generic for Glynase
Glynase contains glyburide. 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 Glynase is glyburide. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
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Glynase products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 1.5MG | Discontinued | None | 1 | None |
| tablet, oral | 3MG | Discontinued | None | 1 | None |
| tablet, oral | 4.5MG | Discontinued | None | 1 | None |
| tablet, oral | 6MG | Discontinued | None | 1 | None |
NDA 020051, 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 glyburide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 074686 | None (No TE code listed) | April 20, 1999 | 1.5MG, 3MG, 4.5MG, 6MG |
Questions
Is there a generic for Glynase?
Yes. The generic name for Glynase is glyburide. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
What is the generic name for Glynase?
The active ingredient in Glynase is glyburide, 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.