FDA Orange Book
Generic for Glucotrol XL
Glucotrol XL 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 XL is glipizide. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Glucotrol XL products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 10MG | Marketed (Rx) | AB | 4 | AB |
| tablet, extended release, oral | 2.5MG | Discontinued | None | 4 | AB |
| tablet, extended release, oral | 5MG | Marketed (Rx) | AB | 4 | AB |
NDA 020329, 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 |
|---|---|---|---|---|
| WATSON LABORATORIES INC | 076467 | AB (A-rated, therapeutically equivalent) | November 7, 2003 | 10MG, 2.5MG, 5MG |
| UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD | 204720 | AB (A-rated, therapeutically equivalent) | December 29, 2016 | 10MG, 2.5MG, 5MG |
| AUROBINDO PHARMA LTD | 206928 | AB (A-rated, therapeutically equivalent) | May 12, 2017 | 10MG, 2.5MG, 5MG |
| ZYDUS PHARMACEUTICALS USA INC | 203499 | AB (A-rated, therapeutically equivalent) | July 16, 2018 | 10MG, 2.5MG, 5MG |
Glucotrol XL NDC codes
Questions
Is there a generic for Glucotrol XL?
Yes. The generic name for Glucotrol XL is glipizide. 4 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 XL?
The active ingredient in Glucotrol XL 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.