Glipizide

Product NDC
68071-4498
Requested package NDC
68071-4498-2
11-digit product format
680714498
Labeler code
68071
Product ID
68071-4498_d7750461-1211-6fb1-e053-2a95a90a12d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA204720
Marketing category
ANDA
Marketing start
2017-04-24
Marketing end
0000-00-00
Substance
GLIPIZIDE
Active strength
10 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage68071-449868071-4498-2DDiscontinued by firm2026-08-11

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 · 12 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…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204720-001GLIPIZIDEGLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29
A204720-002GLIPIZIDEGLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29
A204720-003GLIPIZIDEGLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A204720-001AB
A204720-002AB
A204720-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-12-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-12-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-298072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204720-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204720-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204720-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204720-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204720-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204720-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204720-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204720-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204720-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204720-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204720-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204720-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204720-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204720-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204720-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204720-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204720-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204720-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204720-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204720-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204720-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204720-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204720-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204720-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204720-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204720-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204720-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204720-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204720-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204720-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204720-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204720-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204720-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204720-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204720-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204720-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204720-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204720-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204720-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204720-001AB18072bd15b7f6…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68071-4498-22022-02-07These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994
68071-4498-32022-02-07These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994
68071-4498-62022-02-07These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994
68071-4498-82022-02-07These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994
68071-4498-22022-01-28These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994
68071-4498-32022-01-28These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994
68071-4498-62022-01-28These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994
68071-4498-82022-01-28These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlipizideGLIPIZIDEREMEDYREPACK INC.03151cb5-d32b-4484-8f2a-8c5d24c7f6f12026-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDEREMEDYREPACK INC.c2aadc88-22d2-467c-b2cb-03efb5a1f1c12026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDEPreferred Pharmaceuticals Inc.548c1f50-dbf0-49cc-b58b-fcc5937affa82026-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDEPreferred Pharmaceuticals Inc.4632b4ec-d2f1-40cc-8ef4-256413d8dbec2026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDEA-S Medication Solutionsa34b58ac-42b2-4a19-a28b-cb3144ea55cd2026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDEREMEDYREPACK INC.bde478e6-e290-47e0-9241-ce88d927633e2026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDERising Pharma Holdings, Inc.0ffe361a-c99b-4f68-a7e2-a67a71c0c4962026-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDENorthwind Health Company, LLCab2f4ea6-46e8-268a-e053-2995a90a39772026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDENorthwind Health Company, LLCff9b3b7a-5ab1-45ec-e053-6294a90af4262026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDEBryant Ranch Prepack0338aff9-29f9-405e-b516-06ef4b8638632024-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDEA-S Medication Solutions4982f018-c53c-48ec-a4e8-4834228bcf2c2023-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4498-268071449802120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68071-4498-2) 2018-07-170000-00-00NoNoCurrent