FDA Orange Book
Generic for Micronase
Micronase 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 Micronase is glyburide. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.
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Micronase products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 1.25MG | Discontinued | None | 7 | AB1, AB2 |
| tablet, oral | 2.5MG | Discontinued | None | 7 | AB1, AB2 |
| tablet, oral | 5MG | Discontinued | None | 7 | AB1, AB2 |
NDA 017498, 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 | 074388 | AB1 (A-rated, therapeutically equivalent) | August 29, 1995 | 1.25MG, 2.5MG, 5MG |
| EPIC PHARMA LLC | 076257 | AB1 (A-rated, therapeutically equivalent) | June 27, 2002 | 1.25MG, 2.5MG, 5MG |
| HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC | 090937 | AB1 (A-rated, therapeutically equivalent) | February 28, 2011 | 1.25MG, 2.5MG, 5MG |
| IMPAX LABORATORIES INC | 206079 | AB2 (A-rated, therapeutically equivalent) | September 30, 2015 | 1.25MG, 2.5MG, 5MG |
| ZYDUS PHARMACEUTICALS USA INC | 206749 | AB1 (A-rated, therapeutically equivalent) | May 10, 2016 | 1.25MG, 2.5MG, 5MG |
| CADILA PHARMACEUTICALS LTD | 203379 | AB1 (A-rated, therapeutically equivalent) | January 4, 2019 | 1.25MG, 2.5MG, 5MG |
| ORIENT PHARMA CO LTD | 206483 | AB1 (A-rated, therapeutically equivalent) | February 22, 2019 | 1.25MG, 2.5MG, 5MG |
Questions
Is there a generic for Micronase?
Yes. The generic name for Micronase is glyburide. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.
What is the generic name for Micronase?
The active ingredient in Micronase 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.