Glipizide

Product NDC
67544-129
Requested package NDC
67544-129-92
11-digit product format
675440129
Labeler code
67544
Product ID
67544-129_2a2d2924-8487-4fcb-8bcd-9f7bc95dfa55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA074223
Marketing category
ANDA
Marketing start
1995-02-27
Marketing end
0000-00-00
Substance
GLIPIZIDE
Active strength
10 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 packagepackage67544-12967544-129-92IInactivated 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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29EExcluded after deficient or non-compliant submission was not correctedfb8cb913e6d1…eb8c232b6be0…

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
A074223-001GLIPIZIDEGLIPIZIDE5MGTABLET / ORALAB1995-02-27
A074223-002GLIPIZIDEGLIPIZIDE10MGTABLET / ORALAB1995-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074223-001AB
A074223-002AB

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 UTC2026-02A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-27782e0a99824c…
2021-12-28 21:50 UTC2021-12A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-27782e0a99824c…

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 UTC2026-02A074223-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074223-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074223-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074223-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074223-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074223-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074223-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074223-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074223-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074223-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074223-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074223-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074223-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074223-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074223-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074223-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074223-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074223-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074223-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074223-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074223-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074223-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074223-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074223-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074223-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074223-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074223-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074223-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074223-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074223-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074223-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074223-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074223-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074223-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074223-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074223-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074223-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074223-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074223-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A074223-002AB1782e0a99824c…

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
67544-129-53Glipizide60 in 1 BOTTLE, PLASTICTABLET601
67544-129-60Glipizide90 in 1 BOTTLE, PLASTICTABLET901
67544-129-70Glipizide120 in 1 BOTTLE, PLASTICTABLET1201
67544-129-80Glipizide180 in 1 BOTTLE, PLASTICTABLET1801
67544-129-92Glipizide270 in 1 BOTTLE, PLASTICTABLET2701
67544-129-94Glipizide360 in 1 BOTTLE, PLASTICTABLET3601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-129-60EA - Each67544-12929ecc19f-69b1-43ca-a3c6-2a295ca2768612019-06-19
67544-129-80EA - Each67544-129128db5e3-9ac0-46c6-b23a-2177e4ed2c4b12019-08-06
67544-129-92EA - Each67544-129cd1aacb9-10d7-45c5-9738-9768f4d01f3e12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-129GLIPIZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 6 package rows20190530_fc190807-9e35-4cfe-a1db-a31883104e91.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 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlipizideGLIPIZIDEPreferred Pharmaceuticals Inc..02857195-33e9-4c1f-9e5f-7cc62f2836492026-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDEPreferred Pharmaceuticals Inc.65ddb8b3-19d4-482f-8aec-49dc167a4c402026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDEA-S Medication Solutions99af53db-e102-427a-a5a2-be1e69b3152d2026-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDENorthwind Health Company, LLC3bb3b80a-30e8-62fe-e054-00144ff8d46c2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDEPD-Rx Pharmaceuticals, Inc.c829b7bf-1a12-44b2-b5ce-fd44a1f0d3332025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDEProficient Rx LPd5398166-5698-4ee5-bd41-3c24e4445b532025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDENuCare Pharmaceuticals,Inc.5c627a52-e4ca-7103-e053-2a91aa0ae13f2025-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDEA-S Medication Solutionsb31ab6dd-0277-43ee-a054-f20c462f0c562025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDEBryant Ranch Prepackafb65cc1-a4fb-4771-b09c-dcf6e8c5786e2024-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDENuCare Pharmaceuticals,Inc.589dc76d-c347-0589-e053-2991aa0a25202024-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDENuCare Pharmaceuticals,Inc.8c27962d-626b-30e6-e053-2a95a90a49c62024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDENuCare Pharmaceuticals,Inc.7c21db4d-6b9b-36c3-e053-2991aa0a0fd92024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDEActavis Pharma, Inc.ad55dfd7-ffb5-478a-aa84-1009fa921e222023-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDEA-S Medication Solutions0874340a-75a1-4ac9-b224-80c5c24e1b412023-12-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDENCS HealthCare of KY, LLC dba Vangard Labsbf5ff427-3ee4-4064-a55e-35daa2f12a062023-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDEAphena Pharma Solutions - Tennessee, LLCd6c016f7-bf93-4322-a179-d4798234b3812017-08-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310488glipiZIDE 10 MG Oral TabletPSNfc190807-9e35-4cfe-a1db-a31883104e911
310488glipizide 10 MG Oral TabletSCDfc190807-9e35-4cfe-a1db-a31883104e911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67544-129-9267544012992270 TABLET in 1 BOTTLE, PLASTIC (67544-129-92) 270 tablet2016-07-150000-00-00NoNoCurrent