GLYBURIDE

Product NDC
23155-056
11-digit product format
231550056
Labeler code
23155
Product ID
23155-056_98ed9f46-1633-4f82-bd51-ff87b0157871
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLYBURIDE
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA090937
Marketing category
ANDA
Marketing start
2010-10-05
Substance
GLYBURIDE
Active strength
1.25 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
GLYBURIDE1.25 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197737Internal RxNorm lookup
310534Internal RxNorm lookup
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
33418bba-c5ea-4c0f-9d28-31dc2724c6c3Available 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
23155-056-01GLYBURIDE100 in 1 BOTTLETABLET10012
23155-056-10GLYBURIDE1000 in 1 BOTTLETABLET100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-056-01EA - Each23155-0563dee511a-a261-48e7-93a5-98cc956a3dcf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYBURIDEACTIVE INGREDIENTSX6K58TVWCGLYBURIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
GLYBURIDEACTIVE MOIETYSX6K58TVWCGLYBURIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLYBURIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLYBURIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGLYBURIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLYBURIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLYBURIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-056GLYBURIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 2 package rows20241215_33418bba-c5ea-4c0f-9d28-31dc2724c6c3.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
ndc (product): 23155-056
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
197737glyBURIDE 1.25 MG Oral TabletPSN33418bba-c5ea-4c0f-9d28-31dc2724c6c312
310534glyBURIDE 2.5 MG Oral TabletPSN33418bba-c5ea-4c0f-9d28-31dc2724c6c312
310537glyBURIDE 5 MG Oral TabletPSN33418bba-c5ea-4c0f-9d28-31dc2724c6c312
197737glyburide 1.25 MG Oral TabletSCD33418bba-c5ea-4c0f-9d28-31dc2724c6c312
310534glyburide 2.5 MG Oral TabletSCD33418bba-c5ea-4c0f-9d28-31dc2724c6c312
310537glyburide 5 MG Oral TabletSCD33418bba-c5ea-4c0f-9d28-31dc2724c6c312
197737glibenclamide 1.25 MG Oral TabletSY33418bba-c5ea-4c0f-9d28-31dc2724c6c312
310534glibenclamide 2.5 MG Oral TabletSY33418bba-c5ea-4c0f-9d28-31dc2724c6c312
310537glibenclamide 5 MG Oral TabletSY33418bba-c5ea-4c0f-9d28-31dc2724c6c312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-056-0123155005601100 TABLET in 1 BOTTLE (23155-056-01) 100 tablet2010-10-050000-00-00NoNoCurrent
23155-056-10231550056101000 TABLET in 1 BOTTLE (23155-056-10) 1000 tablet2010-10-050000-00-00NoNoCurrent