Glipizide

Product NDC
61145-203
11-digit product format
611450203
Labeler code
61145
Product ID
61145-203_e8c7786c-a0cb-4a37-a194-c8f2e7ea2d3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glipizide
Dosage form
TABLET
Route
ORAL
Labeler
RePharm Pharmaceuticals
Application
ANDA074226
Marketing category
ANDA
Marketing start
2019-06-01
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61145-203IInactivated by FDA2026-08-17
excluded packagepackage61145-20361145-203-50IInactivated by FDA2026-08-17

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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61145-203-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61145-203-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61145-203-502ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61145-203-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61145-203-50cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61145-203-50cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61145-203-50302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61145-203-50ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61145-203-500efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61145-203-50ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61145-203-50367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61145-203-50557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61145-203-508af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61145-203-50834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61145-203-501332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage61145-203-50fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61145-203-5086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61145-203-50bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage61145-203-508dfbde2a14a4…c9ff85d89658…

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

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
A074226-001GLIPIZIDEGLIPIZIDE5MGTABLET / ORALAB1994-05-10
A074226-002GLIPIZIDEGLIPIZIDE10MGTABLET / ORALAB1994-05-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074226-001AB
A074226-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-10caaa826d4ba7…
2026-08-18 06:07:402026-07A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-10bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-10bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A074226-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074226-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074226-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074226-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074226-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074226-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074226-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074226-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074226-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074226-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074226-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074226-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074226-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074226-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074226-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074226-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074226-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074226-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074226-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074226-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074226-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074226-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074226-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074226-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074226-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074226-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074226-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074226-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074226-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074226-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074226-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074226-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074226-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074226-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074226-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074226-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074226-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074226-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074226-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074226-002AB1bb7c543d1eb4…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61145-203-502021-01-29C16284748780-1ba0f9c33-5a4b-a910-e053-dadaa90a0b85Glipizide Tablets, USP 5 mg and 10 mg For Oral Use Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61145-203-50Glipizide500 in 1 BOTTLE, PLASTICTABLET50010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61145-203GLIPIZIDE TABLET [REPHARM PHARMACEUTICALS]10Legacy NDC, 1 package rows20190612_466a8103-384e-4ac1-9445-ea70d6c74cad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310488glipiZIDE 10 MG Oral TabletPSN466a8103-384e-4ac1-9445-ea70d6c74cad10
310490glipiZIDE 5 MG Oral TabletPSN466a8103-384e-4ac1-9445-ea70d6c74cad10
310488glipizide 10 MG Oral TabletSCD466a8103-384e-4ac1-9445-ea70d6c74cad10
310490glipizide 5 MG Oral TabletSCD466a8103-384e-4ac1-9445-ea70d6c74cad10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61145-203-5061145020350500 in 1 BOTTLE, PLASTICHistorical