Glipizide

Product NDC
64725-0139
11-digit product format
647250139
Labeler code
64725
Product ID
64725-0139_5c19918f-203d-46cb-b7ac-f4d81a6f9a90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glipizide
Dosage form
TABLET
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA074550
Marketing category
ANDA
Marketing start
2011-03-01
Marketing end
0000-00-00
Substance
GLIPIZIDE
Active strength
5 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64725-0139IInactivated by FDA2026-08-17
excluded packagepackage64725-013964725-0139-1IInactivated by FDA2026-08-17

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64725-0139-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64725-0139-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64725-0139-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64725-0139-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64725-0139-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64725-0139-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64725-0139-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64725-0139-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64725-0139-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64725-0139-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64725-0139-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64725-0139-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage64725-0139-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage64725-0139-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage64725-0139-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage64725-0139-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage64725-0139-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage64725-0139-1IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage64725-0139-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage64725-0139-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage64725-0139-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage64725-0139-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074550-001GLIPIZIDEGLIPIZIDE5MGTABLET / ORAL1997-09-11
A074550-002GLIPIZIDEGLIPIZIDE10MGTABLET / ORAL1997-09-11

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074550-001GLIPIZIDE5MGTABLET / ORALAB1997-09-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074550-002GLIPIZIDE10MGTABLET / ORALAB1997-09-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074550-001GLIPIZIDE5MGTABLET / ORALAB1997-09-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074550-002GLIPIZIDE10MGTABLET / ORALAB1997-09-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074550-001GLIPIZIDE5MGTABLET / ORALAB1997-09-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074550-002GLIPIZIDE10MGTABLET / ORALAB1997-09-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074550-001GLIPIZIDE5MGTABLET / ORALAB1997-09-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074550-002GLIPIZIDE10MGTABLET / ORALAB1997-09-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074550-001GLIPIZIDE5MGTABLET / ORALAB1997-09-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074550-002GLIPIZIDE10MGTABLET / ORALAB1997-09-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074550-001GLIPIZIDE5MGTABLET / ORALAB1997-09-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074550-002GLIPIZIDE10MGTABLET / ORALAB1997-09-11bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05A074550-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074550-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074550-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074550-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074550-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074550-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074550-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074550-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074550-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074550-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074550-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074550-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074550-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A074550-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074550-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074550-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A074550-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A074550-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074550-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A074550-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074550-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A074550-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074550-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A074550-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074550-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A074550-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074550-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A074550-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074550-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074550-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074550-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A074550-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074550-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A074550-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074550-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074550-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074550-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074550-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074550-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074550-002AB1a67488948f0b…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ec4adfb0-aabc-95b9-ad07-5cb8f8533a09Product name220250625
b1de1ca9-d9db-4f4b-2103-09e2014d30d5Product name520180912
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-0139-12020-01-31C16284748780-19d75b9d0-e920-f424-e053-dadaa90a57ceGLIPIZIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0139-1Glipizide100 in 1 BOTTLETABLET1002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
glipizideACTIVE INGREDIENTX7WDT95N5CGLIPIZIDE TABLET [TYA PHARMACEUTICALS]2
glipizideACTIVE MOIETYX7WDT95N5CGLIPIZIDE TABLET [TYA PHARMACEUTICALS]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKGLIPIZIDE TABLET [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIPIZIDE TABLET [TYA PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GLIPIZIDE TABLET [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGLIPIZIDE TABLET [TYA PHARMACEUTICALS]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGLIPIZIDE TABLET [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0139GLIPIZIDE TABLET [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20141110_deb9ba3d-0141-4701-bd59-0fad505e0220.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310490glipiZIDE 5 MG Oral TabletPSNdeb9ba3d-0141-4701-bd59-0fad505e02202
310490glipizide 5 MG Oral TabletSCDdeb9ba3d-0141-4701-bd59-0fad505e02202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-0139-164725013901100 in 1 BOTTLEHistorical