Glipizide

Product NDC
51655-106
11-digit product format
516550106
Labeler code
51655
Product ID
51655-106_48c31243-aa64-8632-e063-6294a90a138c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA075795
Marketing category
ANDA
Marketing start
2014-12-30
Substance
GLIPIZIDE
Active strength
10 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51655-106-52e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51655-106-25e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51655-106-26e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51655-106-529bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51655-106-259bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51655-106-269bebd1f3094a…5416666fcb17…

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
A075795-001GLIPIZIDEGLIPIZIDE5MGTABLET / ORALAB2001-06-13
A075795-002GLIPIZIDEGLIPIZIDE10MGTABLET / ORALABRS2001-06-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075795-001AB
A075795-002AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075795-002GLIPIZIDE10MGTABLET / ORALAB2001-06-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075795-002GLIPIZIDE10MGTABLET / ORALAB2001-06-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075795-002GLIPIZIDE10MGTABLET / ORALAB2001-06-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075795-002GLIPIZIDE10MGTABLET / ORALAB2001-06-13bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075795-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075795-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075795-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075795-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075795-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075795-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075795-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075795-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075795-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075795-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075795-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075795-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075795-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075795-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075795-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075795-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075795-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075795-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075795-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075795-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075795-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075795-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075795-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075795-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075795-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075795-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075795-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075795-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075795-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075795-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075795-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075795-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075795-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075795-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075795-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075795-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075795-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075795-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075795-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075795-002AB1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Glipizide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLIPIZIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
X7WDT95N5CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310488Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0ed5ed22-dd53-495d-bc10-0bede4d87926Available on FDA.report

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-106-25Glipizide60 in 1 BOTTLE, DISPENSINGTABLET606
51655-106-26Glipizide90 in 1 BOTTLE, DISPENSINGTABLET906
51655-106-52Glipizide30 in 1 BOTTLE, DISPENSINGTABLET306

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIPIZIDEACTIVE INGREDIENTX7WDT95N5CGLIPIZIDE TABLET [NORTHWIND PHARMACEUTICALS]2
GLIPIZIDEACTIVE MOIETYX7WDT95N5CGLIPIZIDE TABLET [NORTHWIND PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-106GLIPIZIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 3 package rows20231219_0ed5ed22-dd53-495d-bc10-0bede4d87926.zip

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 2 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlipizideGLIPIZIDEREMEDYREPACK INC.376ce3cf-4e1b-4b5f-b3e7-cc9fc4a5aeb42026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDEREMEDYREPACK INC.212897cb-7de7-4711-aaf4-44234f950e9f2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDEAmerican Health Packagingff6805bb-b5f0-46d3-bf1d-3333b63ff1ae2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDECoupler LLC53e650f1-f755-e3ad-e063-6294a90ae3092026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDECoupler LLC51b35391-7672-c02f-e063-6294a90af54e2026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDECardinal Health 107, LLCbf1f5a5d-79b0-4fc5-96f2-bd5119b56e2a2026-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDEPreferred Pharmaceuticals, Inc.097424ef-612f-4bc2-809a-e5bb8eeae2442026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDEMajor Pharmaceuticalsd3b5677c-2265-47c8-beeb-bf12106056ba2026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDELegacy Pharmaceutical Packaging, LLC116ffc6a-735c-49e0-a9d5-69b6bc3e37062026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDEA-S Medication Solutions9c9a3688-6de9-41db-af82-c4aa9b5b3f922026-02-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDEPD-Rx Pharmaceuticals, Inc.f60b0690-aca9-40ec-956e-bd2ecc35ec542026-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDEA-S Medication Solutions383540fd-2931-49bf-8009-25e8f7fc9bda2026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDEA-S Medication Solutionsa38cfe61-4aa5-498c-bca5-03a8213303bb2026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDENorthwind Health Company, LLC0ed5ed22-dd53-495d-bc10-0bede4d879262026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
ndc (product): 51655-106
GlipizideGLIPIZIDENuCare Pharmaceuticals,Inc.6282c653-9e9c-6810-e053-2991aa0a4a8e2026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDEAvPAKaa1b16bf-e01c-d539-e053-2995a90a27352026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDENorthwind Health Company, LLCc16edad6-4271-6ff0-e053-2a95a90a02402026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDEA-S Medication Solutions16fb8bc7-1db1-477e-a201-b3b678b8a84c2025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDEPD-Rx Pharmaceuticals, Inc.1b2e5656-9da9-4fab-bf01-ed75896b836a2025-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDEApotex Corp.dcf426b8-bcdc-8214-a1b6-6388bd3399a02025-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310488glipiZIDE 10 MG Oral TabletPSN0ed5ed22-dd53-495d-bc10-0bede4d879266
310488glipizide 10 MG Oral TabletSCD0ed5ed22-dd53-495d-bc10-0bede4d879266

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-106-255165501062560 TABLET in 1 BOTTLE, DISPENSING (51655-106-25) 60 tablet2014-12-300000-00-00NoNoCurrent
51655-106-265165501062690 TABLET in 1 BOTTLE, DISPENSING (51655-106-26) 90 tablet2014-12-300000-00-00NoNoCurrent
51655-106-525165501065230 TABLET in 1 BOTTLE, DISPENSING (51655-106-52) 30 tablet2014-12-300000-00-00NoNoCurrent