Glipizide

Product NDC
59762-0541
Requested package NDC
59762-0541-2
11-digit product format
597620541
Labeler code
59762
Product ID
59762-0541_cf7479ea-f3c5-4b69-8cb0-264436ec14f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glipizide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Greenstone LLC
Application
NDA020329
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2013-05-29
Marketing end
0000-00-00
Substance
GLIPIZIDE
Active strength
5 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59762-054159762-0541-2DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020329-001GLUCOTROL XLGLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-26
N020329-002GLUCOTROL XLGLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-26
N020329-003GLUCOTROL XLGLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALRLD1999-08-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N020329-001AB
N020329-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-26caaa826d4ba7…
2026-08-18 06:07:402026-07N020329-002GLUCOTROL XL10MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-26caaa826d4ba7…
2026-08-18 06:07:402026-07N020329-003GLUCOTROL XL2.5MGTABLET, EXTENDED RELEASE / ORALRLD1999-08-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020329-002GLUCOTROL XL10MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020329-003GLUCOTROL XL2.5MGTABLET, EXTENDED RELEASE / ORALRLD1999-08-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020329-002GLUCOTROL XL10MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020329-003GLUCOTROL XL2.5MGTABLET, EXTENDED RELEASE / ORALRLD1999-08-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020329-002GLUCOTROL XL10MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020329-003GLUCOTROL XL2.5MGTABLET, EXTENDED RELEASE / ORALRLD1999-08-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALRLD1994-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020329-002GLUCOTROL XL10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS1994-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020329-003GLUCOTROL XL2.5MGTABLET, EXTENDED RELEASE / ORALABRLD1999-08-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALRLD1994-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020329-002GLUCOTROL XL10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS1994-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020329-003GLUCOTROL XL2.5MGTABLET, EXTENDED RELEASE / ORALABRLD1999-08-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALRLD1994-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020329-002GLUCOTROL XL10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS1994-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020329-003GLUCOTROL XL2.5MGTABLET, EXTENDED RELEASE / ORALABRLD1999-08-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALRLD1994-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020329-002GLUCOTROL XL10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS1994-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020329-003GLUCOTROL XL2.5MGTABLET, EXTENDED RELEASE / ORALABRLD1999-08-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020329-002GLUCOTROL XL10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS1994-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020329-003GLUCOTROL XL2.5MGTABLET, EXTENDED RELEASE / ORALABRLD1999-08-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020329-002GLUCOTROL XL10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS1994-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020329-003GLUCOTROL XL2.5MGTABLET, EXTENDED RELEASE / ORALABRLD1999-08-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N020329-002GLUCOTROL XL10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS1994-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N020329-003GLUCOTROL XL2.5MGTABLET, EXTENDED RELEASE / ORALABRLD1999-08-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020329-002GLUCOTROL XL10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS1994-04-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020329-003GLUCOTROL XL2.5MGTABLET, EXTENDED RELEASE / ORALABRLD1999-08-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020329-002GLUCOTROL XL10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS1994-04-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020329-003GLUCOTROL XL2.5MGTABLET, EXTENDED RELEASE / ORALABRLD1999-08-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-261e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N020329-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020329-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020329-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020329-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020329-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020329-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020329-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020329-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020329-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020329-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020329-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020329-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020329-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020329-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020329-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020329-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020329-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020329-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020329-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020329-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020329-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020329-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020329-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020329-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020329-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020329-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020329-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020329-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020329-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020329-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020329-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020329-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020329-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020329-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020329-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020329-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020329-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020329-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020329-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020329-003AB15c6f7cd8ea54…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N020329-001RE444592019-03-26U-14312013-09-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020329-002RE444592019-03-26U-14312013-09-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020329-003RE444592019-03-26U-14312013-09-2074a2ff9319b5…
2019-12-14 00:12 UTC2019-12N020329-001RE444592019-03-26U-14312013-09-203f01610625f2…
2019-12-14 00:12 UTC2019-12N020329-002RE444592019-03-26U-14312013-09-203f01610625f2…
2019-12-14 00:12 UTC2019-12N020329-003RE444592019-03-26U-14312013-09-203f01610625f2…
2019-09-15 20:21 UTC2019-09N020329-001RE444592019-03-26U-14312013-09-20b00525d2431f…
2019-09-15 20:21 UTC2019-09N020329-002RE444592019-03-26U-14312013-09-20b00525d2431f…
2019-09-15 20:21 UTC2019-09N020329-003RE444592019-03-26U-14312013-09-20b00525d2431f…
2019-07-19 19:46 UTC2019-07N020329-001RE444592019-03-26U-14312013-09-20ea99ee380514…
2019-07-19 19:46 UTC2019-07N020329-002RE444592019-03-26U-14312013-09-20ea99ee380514…
2019-07-19 19:46 UTC2019-07N020329-003RE444592019-03-26U-14312013-09-20ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-0541-1EA - Each59762-054102000776-bc4e-4997-9c0a-019f2e3ea26412013-06-04
59762-0541-2EA - Each59762-0541cfe7e6e0-334b-41a8-b504-04b5bccf9bcb12013-09-04

DailyMed Socrata Ingredients#

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glucotrol XLGLIPIZIDERoerigeed99b60-d043-4249-9b2a-f05e46fb588d2026-07-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 020329
application number: NDA020329

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59762-0541-259762054102500 TABLET, EXTENDED RELEASE in 1 BOTTLE (59762-0541-2) 2013-05-290000-00-00NoNoCurrent