FDA Orange Book
Generic for Glucotrol
Glucotrol contains glipizide. 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 Glucotrol is glipizide. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Glucotrol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Discontinued | None | 8 | AB |
| tablet, oral | 2.5MG | Discontinued | None | 2 | AB |
| tablet, oral | 5MG | Discontinued | None | 8 | AB |
NDA 017783, 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 glipizide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA USA INC | 074226 | AB (A-rated, therapeutically equivalent) | May 10, 1994 | 10MG, 5MG |
| OXFORD PHARMACEUTICALS LLC | 074378 | AB (A-rated, therapeutically equivalent) | November 28, 1994 | 10MG, 5MG |
| WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 074223 | AB (A-rated, therapeutically equivalent) | February 27, 1995 | 10MG, 5MG |
| AIPING PHARMACEUTICAL INC | 074305 | AB (A-rated, therapeutically equivalent) | April 7, 1995 | 10MG, 2.5MG, 5MG |
| ANI PHARMACEUTICALS INC | 074497 | AB (A-rated, therapeutically equivalent) | August 31, 1995 | 10MG, 5MG |
| APOTEX INC | 075795 | AB (A-rated, therapeutically equivalent) | June 13, 2001 | 10MG, 5MG |
| RUBICON RESEARCH LTD | 214874 | AB (A-rated, therapeutically equivalent) | October 3, 2023 | 10MG, 2.5MG, 5MG |
| GRAVITI PHARMACEUTICALS PRIVATE LTD | 219159 | AB (A-rated, therapeutically equivalent) | March 4, 2026 | 10MG, 5MG |
Questions
Is there a generic for Glucotrol?
Yes. The generic name for Glucotrol is glipizide. 8 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 Glucotrol?
The active ingredient in Glucotrol is glipizide, 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.