Glyburide

Product NDC
63187-659
11-digit product format
631870659
Labeler code
63187
Product ID
63187-659_cd9ac2ca-699f-44bb-89e6-3fe08f6c8b73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090937
Marketing category
ANDA
Marketing start
2010-10-05
Substance
GLYBURIDE
Active strength
2.5 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
GLYBURIDE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSX6K58TVWC
Rxcui310534

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
63187-659-30Glyburide30 in 1 BOTTLETABLET303
63187-659-60Glyburide60 in 1 BOTTLETABLET603
63187-659-90Glyburide90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-659GLYBURIDE TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20191121_b292cb9b-7348-4c07-a871-bc091229fdf8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310534glyBURIDE 2.5 MG Oral TabletPSNb292cb9b-7348-4c07-a871-bc091229fdf83
310534glyburide 2.5 MG Oral TabletSCDb292cb9b-7348-4c07-a871-bc091229fdf83
310534glibenclamide 2.5 MG Oral TabletSYb292cb9b-7348-4c07-a871-bc091229fdf83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-659-306318706593030 TABLET in 1 BOTTLE (63187-659-30) 30 tablet2018-12-010000-00-00NoNoCurrent
63187-659-606318706596060 TABLET in 1 BOTTLE (63187-659-60) 60 tablet2018-12-010000-00-00NoNoCurrent
63187-659-906318706599090 TABLET in 1 BOTTLE (63187-659-90) 90 tablet2018-12-010000-00-00NoNoCurrent