Glipizide

Product NDC
71610-105
11-digit product format
716100105
Labeler code
71610
Product ID
71610-105_cb4966b5-fc0b-416e-a3d3-9153957afd38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075795
Marketing category
ANDA
Marketing start
2002-09-25
Substance
GLIPIZIDE
Active strength
10 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Glipizide
Listing expiration
2026-12-31

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
9f7f880a-1060-431a-a155-884e8cfbdf22Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-105-53Glipizide60 in 1 BOTTLETABLET601
71610-105-60Glipizide90 in 1 BOTTLETABLET901
71610-105-70Glipizide120 in 1 BOTTLETABLET1201
71610-105-80Glipizide180 in 1 BOTTLETABLET1801
71610-105-92Glipizide270 in 1 BOTTLETABLET2701
71610-105-94Glipizide360 in 1 BOTTLETABLET3601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-105-53EA - Each71610-105e0fe3dbe-7f00-40d4-b14f-907d7530375512018-10-11
71610-105-60EA - Each71610-10554a810eb-91a9-42db-9cf3-6612b56f4bfd12018-10-11
71610-105-70EA - Each71610-1050298d4e3-33f4-4216-999d-56162c336e8b12018-10-11
71610-105-80EA - Each71610-1059f8ed794-b8ab-4619-aa72-b8fef741a84d12018-10-11
71610-105-92EA - Each71610-105bc2b5513-d70d-4256-819d-d42500410a7312018-10-11
71610-105-94EA - Each71610-1052d58ed46-87fa-4a03-bcb6-cd545229df2d12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-105GLIPIZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 6 package rows20180831_9f7f880a-1060-431a-a155-884e8cfbdf22.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
310488glipiZIDE 10 MG Oral TabletPSN9f7f880a-1060-431a-a155-884e8cfbdf221
310488glipizide 10 MG Oral TabletSCD9f7f880a-1060-431a-a155-884e8cfbdf221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-105-537161001055360 TABLET in 1 BOTTLE (71610-105-53) 60 tablet2018-07-270000-00-00NoNoCurrent
71610-105-607161001056090 TABLET in 1 BOTTLE (71610-105-60) 90 tablet2018-07-270000-00-00NoNoCurrent
71610-105-7071610010570120 TABLET in 1 BOTTLE (71610-105-70) 120 tablet2018-07-270000-00-00NoNoCurrent
71610-105-8071610010580180 TABLET in 1 BOTTLE (71610-105-80) 180 tablet2018-07-270000-00-00NoNoCurrent
71610-105-9271610010592270 TABLET in 1 BOTTLE (71610-105-92) 270 tablet2018-07-270000-00-00NoNoCurrent
71610-105-9471610010594360 TABLET in 1 BOTTLE (71610-105-94) 360 tablet2018-08-150000-00-00NoNoCurrent