FDA Orange Book
Generic for Glucovance
Glucovance contains glyburide and metformin. 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 Glucovance is glyburide and metformin. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Glucovance products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 1.25MG;250MG | Discontinued | None | 5 | AB |
| tablet, oral | 2.5MG;500MG | Discontinued | None | 5 | AB |
| tablet, oral | 5MG;500MG | Discontinued | None | 5 | AB |
NDA 021178, held by BRISTOL MYERS SQUIBB. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic glyburide and metformin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| IMPAX LABORATORIES LLC | 076345 | AB (A-rated, therapeutically equivalent) | February 18, 2004 | 1.25MG;250MG, 2.5MG;500MG, 5MG;500MG |
| ACTAVIS ELIZABETH LLC | 076716 | AB (A-rated, therapeutically equivalent) | June 28, 2005 | 1.25MG;250MG, 2.5MG;500MG, 5MG;500MG |
| AUROBINDO PHARMA LTD | 077870 | AB (A-rated, therapeutically equivalent) | November 14, 2007 | 1.25MG;250MG, 2.5MG;500MG, 5MG;500MG |
| HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC | 079009 | AB (A-rated, therapeutically equivalent) | June 3, 2009 | 1.25MG;250MG, 2.5MG;500MG, 5MG;500MG |
| ZYDUS PHARMACEUTICALS USA INC | 206748 | AB (A-rated, therapeutically equivalent) | February 29, 2016 | 1.25MG;250MG, 2.5MG;500MG, 5MG;500MG |
Questions
Is there a generic for Glucovance?
Yes. The generic name for Glucovance is glyburide and metformin. 5 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 Glucovance?
The active ingredient in Glucovance is glyburide and metformin, 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.