GLYBURIDE

Product NDC
53002-4170
Requested package NDC
53002-4170-6
11-digit product format
530024170
Labeler code
53002
Product ID
53002-4170_d9161324-f19d-484d-8d54-51436e6d2126
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLYBURIDE
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA090937
Marketing category
ANDA
Marketing start
2010-10-05
Marketing end
0000-00-00
Substance
GLYBURIDE
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53002-417053002-4170-6IInactivated by FDA2026-08-03

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
A090937-001GLYBURIDEGLYBURIDE1.25MGTABLET / ORALAB12011-02-28
A090937-002GLYBURIDEGLYBURIDE2.5MGTABLET / ORALAB12011-02-28
A090937-003GLYBURIDEGLYBURIDE5MGTABLET / ORALAB12011-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090937-001AB1
A090937-002AB1
A090937-003AB1

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 UTC2026-02A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090937-002GLYBURIDE2.5MGTABLET / ORALAB12011-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090937-003GLYBURIDE5MGTABLET / ORALAB12011-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090937-002GLYBURIDE2.5MGTABLET / ORALAB12011-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090937-003GLYBURIDE5MGTABLET / ORALAB12011-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090937-002GLYBURIDE2.5MGTABLET / ORALAB12011-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090937-003GLYBURIDE5MGTABLET / ORALAB12011-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090937-002GLYBURIDE2.5MGTABLET / ORALAB12011-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090937-003GLYBURIDE5MGTABLET / ORALAB12011-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090937-002GLYBURIDE2.5MGTABLET / ORALAB12011-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090937-003GLYBURIDE5MGTABLET / ORALAB12011-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090937-002GLYBURIDE2.5MGTABLET / ORALAB12011-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090937-003GLYBURIDE5MGTABLET / ORALAB12011-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090937-002GLYBURIDE2.5MGTABLET / ORALAB12011-02-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090937-003GLYBURIDE5MGTABLET / ORALAB12011-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090937-002GLYBURIDE2.5MGTABLET / ORALAB12011-02-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090937-003GLYBURIDE5MGTABLET / ORALAB12011-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090937-002GLYBURIDE2.5MGTABLET / ORALAB12011-02-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090937-003GLYBURIDE5MGTABLET / ORALAB12011-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A090937-002GLYBURIDE2.5MGTABLET / ORALAB12011-02-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A090937-003GLYBURIDE5MGTABLET / ORALAB12011-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090937-002GLYBURIDE2.5MGTABLET / ORALAB12011-02-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090937-003GLYBURIDE5MGTABLET / ORALAB12011-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090937-002GLYBURIDE2.5MGTABLET / ORALAB12011-02-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090937-003GLYBURIDE5MGTABLET / ORALAB12011-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090937-002GLYBURIDE2.5MGTABLET / ORALAB12011-02-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090937-003GLYBURIDE5MGTABLET / ORALAB12011-02-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-288072bd15b7f6…

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 UTC2026-02A090937-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090937-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090937-003AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090937-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090937-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090937-003AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090937-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090937-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090937-003AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090937-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090937-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090937-003AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090937-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090937-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090937-003AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090937-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090937-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090937-003AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090937-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090937-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090937-003AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090937-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090937-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090937-003AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090937-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090937-002AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090937-003AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090937-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A090937-002AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A090937-003AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090937-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090937-002AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090937-003AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090937-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090937-002AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090937-003AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090937-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090937-002AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090937-003AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090937-001AB118072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bea938a6-c880-985b-d27b-b59b0d8b5a77Product name320170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2fProduct name120170616
64b2b6e2-1c04-cf4a-db4c-078ed10e1dd6Product name220160609
5a2baaae-1290-c05e-207f-b1367e9eb46aProduct name220151005
b044018d-bcdc-e68d-63da-1ad6886aea64Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-4170-0GLYBURIDE100 in 1 BOTTLETABLET1003
53002-4170-3GLYBURIDE30 in 1 BOTTLETABLET303
53002-4170-6GLYBURIDE60 in 1 BOTTLETABLET603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-4170GLYBURIDE TABLET [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 3 package rows20230609_172ad55b-f2d2-4764-bcf6-8c209dd4b4a0.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GLYBURIDEGLYBURIDEBryant Ranch Prepack9cdd30e7-512a-4f00-a4de-0a154d143ce92026-05-18Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GLYBURIDEGLYBURIDENorthwind Health Company, LLCd9cb9251-7b31-72a0-e053-2a95a90a43152026-01-01Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GLYBURIDEGLYBURIDENorthwind Health Company, LLCdb47a517-f8bb-136f-e053-2a95a90ad8c52026-01-01Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GLYBURIDEGLYBURIDEChartwell RX, LLC7e661288-2d24-4403-86a1-754afa1d04ff2025-12-09Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GLYBURIDEGLYBURIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.33418bba-c5ea-4c0f-9d28-31dc2724c6c32025-10-31Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GlyburideGLYBURIDENuCare Pharmaceuticals,Inc.7ee41cd3-461f-3408-e053-2991aa0a863d2025-02-06Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GLYBURIDEGLYBURIDEBryant Ranch Prepack05341afe-5b7a-462a-a196-689cb09f83fc2025-01-28Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GlyburideGLYBURIDENuCare Pharmaceuticals, Inc.3e354b4d-70e4-5089-e054-00144ff88e882024-08-13Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GLYBURIDEGLYBURIDENuCare Pharmaceuticals,Inc.a12342fb-123c-2951-e053-2a95a90ac5962024-06-20Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GLYBURIDEGLYBURIDENuCare Pharmaceuticals,Inc.a1233548-bbb8-34aa-e053-2a95a90aea532024-06-20Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GlyburideGLYBURIDENuCare Pharmaceuticals,Inc.901c50d5-31e7-b073-e053-2995a90abfeb2024-06-19Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GLYBURIDEGLYBURIDEA-S Medication Solutions7a280f88-26d4-4fe5-a89b-a6f1d90ed3cd2023-12-03Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GLYBURIDEGLYBURIDEA-S Medication Solutions3c91a408-973b-4572-832f-515f61d5be1f2023-02-04Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GlyburideGLYBURIDEProficient Rx LPb292cb9b-7348-4c07-a871-bc091229fdf82019-11-01Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GlyburideGLYBURIDEProficient Rx LP240c3ac6-9aab-4185-994e-a0254e3aeb612019-11-01Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310537glyBURIDE 5 MG Oral TabletPSN172ad55b-f2d2-4764-bcf6-8c209dd4b4a03
310537glyburide 5 MG Oral TabletSCD172ad55b-f2d2-4764-bcf6-8c209dd4b4a03
310537glibenclamide 5 MG Oral TabletSY172ad55b-f2d2-4764-bcf6-8c209dd4b4a03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-4170-65300241700660 TABLET in 1 BOTTLE (53002-4170-6) 60 tablet2020-01-010000-00-00NoNoCurrent