Glipizide

Product NDC
71335-0618
11-digit product format
713350618
Labeler code
71335
Product ID
71335-0618_ee9e9c30-e280-4e22-bf55-849abda82186
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
4995328f-287c-4d4a-9b5f-9d354cc530fbAvailable 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
71335-0618-1Glipizide60 in 1 BOTTLETABLET608
71335-0618-2Glipizide30 in 1 BOTTLETABLET308
71335-0618-3Glipizide100 in 1 BOTTLETABLET1008
71335-0618-4Glipizide120 in 1 BOTTLETABLET1208
71335-0618-5Glipizide90 in 1 BOTTLETABLET908
71335-0618-6Glipizide20 in 1 BOTTLETABLET208
71335-0618-7Glipizide180 in 1 BOTTLETABLET1808

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0618-1EA - Each71335-061858311ba4-54b8-407f-8260-ae8f55f9b94612022-11-07
71335-0618-2EA - Each71335-061823f6794c-67b0-4b79-8899-0278415539a012022-11-07
71335-0618-5EA - Each71335-06189da5004f-5873-4470-b376-392dab8df4a012022-11-07
71335-0618-7EA - Each71335-0618a4a043f8-2bd4-4153-b83e-0db3faae449d12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0618GLIPIZIDE TABLET [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 7 package rows20241025_4995328f-287c-4d4a-9b5f-9d354cc530fb.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 TabletPSN4995328f-287c-4d4a-9b5f-9d354cc530fb8
310488glipizide 10 MG Oral TabletSCD4995328f-287c-4d4a-9b5f-9d354cc530fb8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0618-17133506180160 TABLET in 1 BOTTLE (71335-0618-1) 60 tablet2018-03-200000-00-00NoNoCurrent
71335-0618-27133506180230 TABLET in 1 BOTTLE (71335-0618-2) 30 tablet2018-03-010000-00-00NoNoCurrent
71335-0618-371335061803100 TABLET in 1 BOTTLE (71335-0618-3) 100 tablet2018-02-190000-00-00NoNoCurrent
71335-0618-471335061804120 TABLET in 1 BOTTLE (71335-0618-4) 120 tablet2024-10-080000-00-00NoNoCurrent
71335-0618-57133506180590 TABLET in 1 BOTTLE (71335-0618-5) 90 tablet2018-02-160000-00-00NoNoCurrent
71335-0618-67133506180620 TABLET in 1 BOTTLE (71335-0618-6) 20 tablet2024-10-080000-00-00NoNoCurrent
71335-0618-771335061807180 TABLET in 1 BOTTLE (71335-0618-7) 180 tablet2018-04-100000-00-00NoNoCurrent