GLYBURIDE

Product NDC
71335-0150
Requested package NDC
71335-0150-5
11-digit product format
713350150
Labeler code
71335
Product ID
71335-0150_5e1bb26d-3543-48d5-9a08-c07f5dd5a688
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLYBURIDE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090937
Marketing category
ANDA
Marketing start
2010-10-05
Substance
GLYBURIDE
Active strength
5 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 packagepackage71335-015071335-0150-5DDiscontinued by firm2026-08-03

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 · 12 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 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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…

Additional Listing Data#

Finished product
Yes
Brand name base
GLYBURIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYBURIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SX6K58TVWCInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310537Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
05341afe-5b7a-462a-a196-689cb09f83fcAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0150-1GLYBURIDE30 in 1 BOTTLETABLET30103
71335-0150-2GLYBURIDE120 in 1 BOTTLETABLET120103
71335-0150-3GLYBURIDE100 in 1 BOTTLETABLET100103
71335-0150-4GLYBURIDE60 in 1 BOTTLETABLET60103
71335-0150-5GLYBURIDE90 in 1 BOTTLETABLET90103
71335-0150-6GLYBURIDE180 in 1 BOTTLETABLET180103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0150-1EA - Each71335-015050c516dd-2561-4ffb-8c23-d48a3a1bc9ef12018-03-08
71335-0150-2EA - Each71335-015005ff37d5-b87d-4ddc-a2e6-fc7ee4f39a3b12018-03-08
71335-0150-3EA - Each71335-015079492804-1a05-4ab2-b9c9-aa6a7b01d88412018-03-08
71335-0150-4EA - Each71335-0150c4014803-05aa-4894-bb05-a8337a7bf94412018-03-08
71335-0150-5EA - Each71335-0150390e4e67-2659-4041-97d5-e99ef23d772512018-03-08
71335-0150-6EA - Each71335-01503514ca31-24cf-406c-9c6a-7473db75163612018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0150GLYBURIDE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 6 package rows20250221_05341afe-5b7a-462a-a196-689cb09f83fc.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
ndc (package): 71335-0150-5
ndc (product): 71335-0150
ndc11 (package): 71335015005
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 TabletPSN05341afe-5b7a-462a-a196-689cb09f83fc103
310537glyburide 5 MG Oral TabletSCD05341afe-5b7a-462a-a196-689cb09f83fc103
310537glibenclamide 5 MG Oral TabletSY05341afe-5b7a-462a-a196-689cb09f83fc103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0150-57133501500590 TABLET in 1 BOTTLE (71335-0150-5) 90 tablet2018-05-230000-00-00NoNoCurrent