Glipizide

Product NDC
50090-3069
11-digit product format
500903069
Labeler code
50090
Product ID
50090-3069_53cc167c-3ad0-4afe-96a4-cbf6994184a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076159
Marketing category
ANDA
Marketing start
2016-12-21
Marketing end
0000-00-00
Substance
GLIPIZIDE
Active strength
5 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-3069IInactivated by FDA2026-08-17
excluded packagepackage50090-306950090-3069-0DDiscontinued by firm2026-08-17
excluded packagepackage50090-306950090-3069-2IInactivated 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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-3069-0DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-3069-2IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-3069-0DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-3069-2IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-3069-0DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-3069-2IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-3069-0DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-3069-2IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-3069-0DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-3069-2IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-3069-0DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-3069-2IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-3069-0DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-3069-2IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-3069-0DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-3069-2IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-3069-0DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-3069-2IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-3069-0DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-3069-2IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-3069-0DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-3069-2IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-3069-0DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-3069-2IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-3069-2IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-3069-2IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-3069-2IInactivated by FDA1332a3947898…d4bfe170f9cd…

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
A076159-001GLIPIZIDEGLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORAL2013-09-20
A076159-002GLIPIZIDEGLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORAL2013-09-20

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 06:07:402026-07A076159-001GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORAL2013-09-20caaa826d4ba7…
2026-08-18 06:07:402026-07A076159-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORAL2013-09-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076159-001GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORAL2013-09-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076159-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORAL2013-09-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076159-001GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORAL2013-09-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076159-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORAL2013-09-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076159-001GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORAL2013-09-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076159-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORAL2013-09-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076159-001GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORAL2013-09-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076159-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORAL2013-09-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076159-001GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORAL2013-09-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076159-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORAL2013-09-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076159-001GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORAL2013-09-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076159-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORAL2013-09-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076159-001GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORAL2013-09-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076159-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORAL2013-09-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076159-001GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORAL2013-09-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076159-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORAL2013-09-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076159-001GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORAL2013-09-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076159-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORAL2013-09-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076159-001GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORAL2013-09-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A076159-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORAL2013-09-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076159-001GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORAL2013-09-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076159-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORAL2013-09-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076159-001GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORAL2013-09-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076159-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORAL2013-09-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076159-001GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORAL2013-09-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076159-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORAL2013-09-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076159-001GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORAL2013-09-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076159-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORAL2013-09-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076159-001GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORAL2013-09-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076159-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORAL2013-09-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076159-001GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORAL2013-09-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076159-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORAL2013-09-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076159-001GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORAL2013-09-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076159-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORAL2013-09-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076159-001GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2013-09-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076159-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2013-09-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076159-001GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORAL2013-09-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076159-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORAL2013-09-20bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A076159-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076159-002AB174a2ff9319b5…
2021-12-28 21:50 UTC2021-12A076159-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A076159-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076159-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076159-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076159-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A076159-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076159-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A076159-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076159-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A076159-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076159-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076159-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076159-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076159-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076159-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076159-002AB1ea99ee380514…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3069-0Glipizide30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3010
50090-3069-2Glipizide90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3069-0EA - Each50090-306915b07696-5027-43ff-8837-8797225d399c12019-02-13
50090-3069-2EA - Each50090-3069f8cc4257-a3a1-46f8-8347-c7e42ceef9a112019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3069GLIPIZIDE TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]10Legacy NDC, 2 package rows20200219_98591ff5-b735-47b0-9bd2-1e9118d261e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSN98591ff5-b735-47b0-9bd2-1e9118d261e610
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSN98591ff5-b735-47b0-9bd2-1e9118d261e610
31510724 HR glipizide 10 MG Extended Release Oral TabletSCD98591ff5-b735-47b0-9bd2-1e9118d261e610
31400624 HR glipizide 5 MG Extended Release Oral TabletSCD98591ff5-b735-47b0-9bd2-1e9118d261e610
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSY98591ff5-b735-47b0-9bd2-1e9118d261e610
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSY98591ff5-b735-47b0-9bd2-1e9118d261e610
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSY98591ff5-b735-47b0-9bd2-1e9118d261e610
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSY98591ff5-b735-47b0-9bd2-1e9118d261e610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3069-05009030690030 in 1 BOTTLEHistorical
50090-3069-25009030690290 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-3069-2) 2016-12-210000-00-00NoNoCurrent