Glipizide

Product NDC
67046-236
Requested package NDC
67046-236-14
11-digit product format
670460236
Labeler code
67046
Product ID
67046-236_5a094758-dc7a-8136-e053-2a91aa0a20a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA075795
Marketing category
ANDA
Marketing start
2017-09-25
Marketing end
0000-00-00
Substance
GLIPIZIDE
Active strength
5 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage67046-23667046-236-14IInactivated by FDA2026-08-07

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 · 18 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…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2021-12-28 21:50 UTC2021-12A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-13782e0a99824c…
2021-12-28 21:50 UTC2021-12A075795-002GLIPIZIDE10MGTABLET / ORALAB2001-06-13782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2021-12-28 21:50 UTC2021-12A075795-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075795-002AB1782e0a99824c…

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
67046-236-07Glipizide7 in 1 BLISTER PACKTABLET71
67046-236-14Glipizide14 in 1 BLISTER PACKTABLET141
67046-236-15Glipizide15 in 1 BLISTER PACKTABLET151
67046-236-20Glipizide20 in 1 BLISTER PACKTABLET201
67046-236-21Glipizide21 in 1 BLISTER PACKTABLET211
67046-236-28Glipizide28 in 1 BLISTER PACKTABLET281
67046-236-30Glipizide30 in 1 BLISTER PACKTABLET301
67046-236-60Glipizide60 in 1 BLISTER PACKTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-236GLIPIZIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170926_5a094758-dc79-8136-e053-2a91aa0a20a1.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
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
310490glipiZIDE 5 MG Oral TabletPSN5a094758-dc79-8136-e053-2a91aa0a20a11
310490glipizide 5 MG Oral TabletSCD5a094758-dc79-8136-e053-2a91aa0a20a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-236-146704602361414 TABLET in 1 BLISTER PACK (67046-236-14) 14 tablet2017-09-250000-00-00NoNoCurrent