Glipizide

Product NDC
59651-268
Requested package NDC
59651-268-71
11-digit product format
596510268
Labeler code
59651
Product ID
59651-268_17329bb9-0057-451a-8621-d6319d8939bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA206928
Marketing category
ANDA
Marketing start
2017-05-12
Marketing end
0000-00-00
Substance
GLIPIZIDE
Active strength
3 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
unfinished packagepackage59651-26859651-268-71UNFINISHEDActive or certified unfinished drug listing2026-08-17

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 · 19 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 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-098d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-1450b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-276db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-188fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-174184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-104bd3596a7b87…5c64c6f6865f…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A206928-001GLIPIZIDEGLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-12
A206928-002GLIPIZIDEGLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-12
A206928-003GLIPIZIDEGLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-05-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206928-001AB
A206928-002AB
A206928-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A206928-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-12caaa826d4ba7…
2026-08-18 06:07:402026-07A206928-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-12caaa826d4ba7…
2026-08-18 06:07:402026-07A206928-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-05-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206928-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206928-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206928-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-05-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206928-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206928-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206928-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-05-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A206928-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206928-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206928-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-05-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206928-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206928-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206928-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-05-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206928-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206928-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206928-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-05-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206928-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206928-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206928-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-05-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206928-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206928-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206928-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-05-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206928-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206928-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206928-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-05-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206928-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206928-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206928-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-05-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206928-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A206928-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A206928-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-05-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206928-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206928-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206928-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-05-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206928-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206928-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206928-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-05-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206928-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2017-05-121e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A206928-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206928-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206928-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206928-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206928-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206928-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206928-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206928-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206928-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206928-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206928-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206928-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206928-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206928-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206928-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206928-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206928-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206928-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206928-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206928-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206928-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206928-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206928-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206928-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206928-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206928-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206928-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206928-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206928-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206928-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206928-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206928-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206928-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206928-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206928-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206928-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206928-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206928-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206928-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206928-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
No
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLIPIZIDE2.5 mg/1

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-268-30EA - Each59651-2684aea6306-5907-4bbe-8aca-2b6b592f276012019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-268GLIPIZIDE TABLET, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]6Legacy NDC20230606_9ace98c0-1115-4157-b611-fee4c915a8bf.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlipizideGLIPIZIDESt. Mary's Medical Park Pharmacy1b2ef6e2-5e7c-761e-e063-6294a90addd02026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206928
application number: ANDA206928
GlipizideGLIPIZIDEREMEDYREPACK INC.0df8f606-97b3-463c-a132-338cf4630a712026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206928
application number: ANDA206928
GlipizideGLIPIZIDESt. Mary's Medical Park Pharmacy0ccc17ca-fff8-0449-e063-6294a90af36d2026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206928
application number: ANDA206928
GlipizideGLIPIZIDEBryant Ranch Prepack2aa01a7e-a703-426f-9cd3-70b88d0a8e7f2026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206928
application number: ANDA206928
GlipizideGLIPIZIDEBryant Ranch Prepackceb86ebb-d00a-4261-90ad-8751e799d93c2026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206928
application number: ANDA206928
GlipizideGLIPIZIDEBryant Ranch Prepack4afa67b2-7f86-4189-93a5-6a605f74540d2026-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206928
application number: ANDA206928
GlipizideGLIPIZIDEREMEDYREPACK INC.667dd68a-d3e7-4b50-bd0a-d17783a090d52026-03-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206928
application number: ANDA206928
GlipizideGLIPIZIDEAurobindo Pharma Limited84794a52-b717-488c-8533-6425c83d405f2026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206928
application number: ANDA206928
GlipizideGLIPIZIDENorthwind Health Company, LLC0a1e1152-ade7-2092-e063-6394a90a99e72025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206928
application number: ANDA206928
GlipizideGLIPIZIDENorthwind Health Company, LLC0effd04d-172c-5d8c-e063-6294a90a93f42025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206928
application number: ANDA206928
GlipizideGLIPIZIDEAmerican Health Packagingaaf029d3-027e-4ae8-8ec5-3a4c16f9bd282025-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206928
application number: ANDA206928
GlipizideGLIPIZIDEA-S Medication Solutions08b01608-73c2-45e0-8de4-c6c4012611522023-10-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206928
application number: ANDA206928
GlipizideGLIPIZIDEA-S Medication Solutions695c178f-77f0-451e-b718-72b65e495b7e2023-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206928
application number: ANDA206928

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startStatus
59651-268-71596510268717000 TABLET, EXTENDED RELEASE in 1 BAG (59651-268-71)12-MAY-17Current