FDA Orange Book · active-ingredient family
Glipizide
Glipizide: 2 brands, 21 generics; first approved May 08, 1984; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 21 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
21
Listed patents
0
Presentations
55
Brand (NDA) products
Originator applications
- GLUCOTROL XLRLDPFIZERNDA 02032919993 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, EXTENDED RELEASE ORAL Rx AB 10MG TABLET, EXTENDED RELEASE ORAL Rx AB 2.5MG TABLET, EXTENDED RELEASE ORAL Discontinued - - GLUCOTROLRLDPFIZERNDA 01778319933 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued - 10MG TABLET ORAL Discontinued - 2.5MG TABLET ORAL Discontinued -
Generic (ANDA) products (21)
Abbreviated applications
- GLIPIZIDEGRAVITI PHARMSANDA 21915920262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - GLIPIZIDERUBICON RESEARCHANDA 21487420234 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx - 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx - - GLIPIZIDEZYDUS PHARMSANDA 20349920183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET, EXTENDED RELEASE ORAL Rx AB 5MG TABLET, EXTENDED RELEASE ORAL Rx AB 10MG TABLET, EXTENDED RELEASE ORAL Rx AB - GLIPIZIDEAUROBINDO PHARMAANDA 20692820173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET, EXTENDED RELEASE ORAL Rx AB 5MG TABLET, EXTENDED RELEASE ORAL Rx AB 10MG TABLET, EXTENDED RELEASE ORAL Rx AB - GLIPIZIDEUNIQUEANDA 20472020163 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET, EXTENDED RELEASE ORAL Rx AB 5MG TABLET, EXTENDED RELEASE ORAL Rx AB 10MG TABLET, EXTENDED RELEASE ORAL Rx AB - GLIPIZIDEPHARMOBEDIENTANDA 20229820153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET, EXTENDED RELEASE ORAL Discontinued - 5MG TABLET, EXTENDED RELEASE ORAL Discontinued - 10MG TABLET, EXTENDED RELEASE ORAL Discontinued - - GLIPIZIDEPH HEALTHANDA 07615920132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, EXTENDED RELEASE ORAL Discontinued - 5MG TABLET, EXTENDED RELEASE ORAL Discontinued - - GLIPIZIDESUN PHARM INDS INCANDA 07782020062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued - 10MG TABLET ORAL Discontinued - - GLIPIZIDEWATSON LABSANDA 07646720063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, EXTENDED RELEASE ORAL Rx AB 10MG TABLET, EXTENDED RELEASE ORAL Rx AB 2.5MG TABLET, EXTENDED RELEASE ORAL Rx AB - GLIPIZIDEAPOTEXANDA 07579520012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - GLIPIZIDEACCORD HLTHCAREANDA 07455019972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued - 10MG TABLET ORAL Discontinued - - GLIPIZIDEBARR LABS INCANDA 07461919972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued - 10MG TABLET ORAL Discontinued - - GLIPIZIDEANI PHARMSANDA 07438719962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued - 10MG TABLET ORAL Discontinued - - GLIPIZIDEANI PHARMSANDA 07449719952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - GLIPIZIDECHARTWELL RXANDA 07454219952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued - 10MG TABLET ORAL Discontinued - - GLIPIZIDEPHARMOBEDIENTANDA 07443819952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued - 10MG TABLET ORAL Discontinued - - GLIPIZIDEAIPING PHARM INCANDA 07430519952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - GLIPIZIDEWATSON LABS TEVAANDA 07422319952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - GLIPIZIDEOXFORD PHARMSANDA 07437819942 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - GLIPIZIDEWATSON LABSANDA 07437019942 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued - 10MG TABLET ORAL Discontinued - - GLIPIZIDEAUROBINDO PHARMA USAANDA 07422619942 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
43 yr 1 mo ago
Most recent approval
8 mo ago
Approvals span 1984–2026 across 23 FDA applications.
Brand (NDA) 29%
Generic (ANDA) 2191%
Glipizide: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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