Glipizide

Product NDC
53002-4460
11-digit product format
530024460
Labeler code
53002
Product ID
53002-4460_76a0cb91-c019-4ca5-8b00-d9929462020d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glipizide
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA074550
Marketing category
ANDA
Marketing start
2011-07-18
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53002-4460IInactivated by FDA2026-08-17
excluded packagepackage53002-446053002-4460-0IInactivated by FDA2026-08-17
excluded packagepackage53002-446053002-4460-3IInactivated by FDA2026-08-17
excluded packagepackage53002-446053002-4460-6IInactivated 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 · 44 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 packagepackage53002-4460-6IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53002-4460-3IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53002-4460-0IInactivated 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 packagepackage53002-4460-6IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53002-4460-3IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53002-4460-0IInactivated 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 packagepackage53002-4460-6IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53002-4460-3IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53002-4460-0IInactivated 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 packagepackage53002-4460-6IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53002-4460-3IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53002-4460-0IInactivated 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 packagepackage53002-4460-6IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53002-4460-3IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53002-4460-0IInactivated 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 packagepackage53002-4460-6IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53002-4460-3IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53002-4460-0IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53002-4460-0UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53002-4460-3UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53002-4460-6UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53002-4460-0UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53002-4460-3UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53002-4460-6UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53002-4460-0UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53002-4460-3UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53002-4460-6UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53002-4460-6IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53002-4460-0IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53002-4460-3IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53002-4460-3IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53002-4460-6IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53002-4460-0IInactivated by FDA9bebd1f3094a…5416666fcb17…

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
A074550-001GLIPIZIDEGLIPIZIDE5MGTABLET / ORAL1997-09-11
A074550-002GLIPIZIDEGLIPIZIDE10MGTABLET / ORAL1997-09-11

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 06:07:402026-07A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074550-001GLIPIZIDE5MGTABLET / ORALAB1997-09-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074550-002GLIPIZIDE10MGTABLET / ORALAB1997-09-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074550-001GLIPIZIDE5MGTABLET / ORALAB1997-09-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074550-002GLIPIZIDE10MGTABLET / ORALAB1997-09-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074550-001GLIPIZIDE5MGTABLET / ORALAB1997-09-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074550-002GLIPIZIDE10MGTABLET / ORALAB1997-09-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074550-001GLIPIZIDE5MGTABLET / ORALAB1997-09-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074550-002GLIPIZIDE10MGTABLET / ORALAB1997-09-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074550-001GLIPIZIDE5MGTABLET / ORALAB1997-09-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074550-002GLIPIZIDE10MGTABLET / ORALAB1997-09-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074550-001GLIPIZIDE5MGTABLET / ORALAB1997-09-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074550-002GLIPIZIDE10MGTABLET / ORALAB1997-09-11bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05A074550-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074550-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074550-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074550-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074550-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074550-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074550-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074550-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074550-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074550-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074550-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074550-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074550-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A074550-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074550-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074550-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A074550-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A074550-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074550-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A074550-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074550-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A074550-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074550-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A074550-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074550-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A074550-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074550-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A074550-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074550-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074550-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074550-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A074550-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074550-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A074550-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074550-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074550-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074550-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074550-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074550-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074550-002AB1a67488948f0b…

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
53002-4460-0Glipizide100 in 1 BOTTLETABLET1007
53002-4460-3Glipizide30 in 1 BOTTLETABLET307
53002-4460-6Glipizide60 in 1 BOTTLETABLET607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-4460GLIPIZIDE TABLET [RPK PHARMACEUTICALS, INC.]7Legacy NDC, 3 package rows20230609_a98b2568-0ce3-4c80-a1aa-a0bf5884564a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310488glipiZIDE 10 MG Oral TabletPSNa98b2568-0ce3-4c80-a1aa-a0bf5884564a7
310490glipiZIDE 5 MG Oral TabletPSNa98b2568-0ce3-4c80-a1aa-a0bf5884564a7
310488glipizide 10 MG Oral TabletSCDa98b2568-0ce3-4c80-a1aa-a0bf5884564a7
310490glipizide 5 MG Oral TabletSCDa98b2568-0ce3-4c80-a1aa-a0bf5884564a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-4460-053002446000100 TABLET in 1 BOTTLE (53002-4460-0) 100 tablet2017-10-010000-00-00NoNoCurrent
53002-4460-35300244600330 TABLET in 1 BOTTLE (53002-4460-3) 30 tablet2017-10-010000-00-00NoNoCurrent
53002-4460-65300244600660 TABLET in 1 BOTTLE (53002-4460-6) 60 tablet2017-10-010000-00-00NoNoCurrent