FDA.reportPublic FDA data

Glyburide

Product NDC
68071-4695
11-digit product format
680714695
Labeler code
68071
Product ID
68071-4695_2d7d4e63-7233-107c-e063-6394a90a72d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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

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 Identifiers#

Field, Values table
FieldValues
UniiSX6K58TVWC
Rxcui310537

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4695-32024-06-12C16284748780-1ba0f9c33-1332-a910-e053-dadaa90a0b85for oral use These highlights do not include all the information needed to use Glyburide safely and effectively. See full prescribing information for Glyburide Glyburide (Glyburide) TABLET for ORAL use. Initial U.S. Approval:
68071-4695-62024-06-12C16284748780-1ba0f9c33-1332-a910-e053-dadaa90a0b85for oral use These highlights do not include all the information needed to use Glyburide safely and effectively. See full prescribing information for Glyburide Glyburide (Glyburide) TABLET for ORAL use. Initial U.S. Approval:
68071-4695-92024-06-12C16284748780-1ba0f9c33-1332-a910-e053-dadaa90a0b85for oral use These highlights do not include all the information needed to use Glyburide safely and effectively. See full prescribing information for Glyburide Glyburide (Glyburide) TABLET for ORAL use. Initial U.S. Approval:
68071-4695-32023-01-30C16284748780-1ba0f9c33-1332-a910-e053-dadaa90a0b85for oral use These highlights do not include all the information needed to use Glyburide safely and effectively. See full prescribing information for Glyburide Glyburide (Glyburide) TABLET for ORAL use. Initial U.S. Approval:
68071-4695-62023-01-30C16284748780-1ba0f9c33-1332-a910-e053-dadaa90a0b85for oral use These highlights do not include all the information needed to use Glyburide safely and effectively. See full prescribing information for Glyburide Glyburide (Glyburide) TABLET for ORAL use. Initial U.S. Approval:
68071-4695-92023-01-30C16284748780-1ba0f9c33-1332-a910-e053-dadaa90a0b85for oral use These highlights do not include all the information needed to use Glyburide safely and effectively. See full prescribing information for Glyburide Glyburide (Glyburide) TABLET for ORAL use. Initial U.S. Approval:
68071-4695-92021-02-17C16284748780-1ba0f9c33-1332-a910-e053-dadaa90a0b85for oral use These highlights do not include all the information needed to use Glyburide safely and effectively. See full prescribing information for Glyburide Glyburide (Glyburide) TABLET for ORAL use. Initial U.S. Approval:
68071-4695-92021-01-29C16284748780-1ba0f9c33-1332-a910-e053-dadaa90a0b85for oral use These highlights do not include all the information needed to use Glyburide safely and effectively. See full prescribing information for Glyburide Glyburide (Glyburide) TABLET for ORAL use. Initial U.S. Approval:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4695-3Glyburide30 in 1 BOTTLETABLET306
68071-4695-6Glyburide60 in 1 BOTTLETABLET606
68071-4695-9Glyburide90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4695GLYBURIDE TABLET [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 3 package rows20250209_7ee41cd3-461f-3408-e053-2991aa0a863d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310537glyBURIDE 5 MG Oral TabletPSN7ee41cd3-461f-3408-e053-2991aa0a863d6
310537glyburide 5 MG Oral TabletSCD7ee41cd3-461f-3408-e053-2991aa0a863d6
310537glibenclamide 5 MG Oral TabletSY7ee41cd3-461f-3408-e053-2991aa0a863d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4695-36807146950330 TABLET in 1 BOTTLE (68071-4695-3) 30 tablet2019-01-070000-00-00NoNoCurrent
68071-4695-66807146950660 TABLET in 1 BOTTLE (68071-4695-6) 60 tablet2019-01-070000-00-00NoNoCurrent
68071-4695-96807146950990 TABLET in 1 BOTTLE (68071-4695-9) 90 tablet2019-01-070000-00-00NoNoCurrent