FDA.reportPublic FDA data

Glyburide

Product NDC
72241-039
11-digit product format
722410039
Labeler code
72241
Product ID
72241-039_7ebf5b06-fdd3-4120-93f2-d31def5bf104
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
Modavar Pharmaceuticals LLC
Application
ANDA203379
Marketing category
ANDA
Marketing start
2021-10-05
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
Rxcui197737, 310534, 310537

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
72241-039-05Glyburide100 in 1 BOTTLETABLET1002
72241-039-10Glyburide500 in 1 BOTTLETABLET5002
72241-039-11Glyburide1000 in 1 BOTTLETABLET10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72241-039GLYBURIDE TABLET [MODAVAR PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 3 package rows20221230_a5de0ef6-4c8b-40ab-b0ed-2003a8086750.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310534glyBURIDE 2.5 MG Oral TabletPSNe23b9a3b-0184-4d1c-8e2c-668697a6da878
310534glyburide 2.5 MG Oral TabletSCDe23b9a3b-0184-4d1c-8e2c-668697a6da878
310534glibenclamide 2.5 MG Oral TabletSYe23b9a3b-0184-4d1c-8e2c-668697a6da878
310534glyBURIDE 2.5 MG Oral TabletPSN676c0e45-0aa2-4060-ad18-67abb9873a505
310534glyburide 2.5 MG Oral TabletSCD676c0e45-0aa2-4060-ad18-67abb9873a505
310534glibenclamide 2.5 MG Oral TabletSY676c0e45-0aa2-4060-ad18-67abb9873a505
197737glyBURIDE 1.25 MG Oral TabletPSNa5de0ef6-4c8b-40ab-b0ed-2003a80867502
310534glyBURIDE 2.5 MG Oral TabletPSNa5de0ef6-4c8b-40ab-b0ed-2003a80867502
310537glyBURIDE 5 MG Oral TabletPSNa5de0ef6-4c8b-40ab-b0ed-2003a80867502
197737glyburide 1.25 MG Oral TabletSCDa5de0ef6-4c8b-40ab-b0ed-2003a80867502
310534glyburide 2.5 MG Oral TabletSCDa5de0ef6-4c8b-40ab-b0ed-2003a80867502
310537glyburide 5 MG Oral TabletSCDa5de0ef6-4c8b-40ab-b0ed-2003a80867502
197737glibenclamide 1.25 MG Oral TabletSYa5de0ef6-4c8b-40ab-b0ed-2003a80867502
310534glibenclamide 2.5 MG Oral TabletSYa5de0ef6-4c8b-40ab-b0ed-2003a80867502
310537glibenclamide 5 MG Oral TabletSYa5de0ef6-4c8b-40ab-b0ed-2003a80867502
310534glyBURIDE 2.5 MG Oral TabletPSN26a39d3f-3f71-31b6-e063-6394a90a7b841
310534glyBURIDE 2.5 MG Oral TabletPSN03c1e0ae-6081-f9a6-e063-6294a90a6d871
310534glyburide 2.5 MG Oral TabletSCD03c1e0ae-6081-f9a6-e063-6294a90a6d871
310534glyburide 2.5 MG Oral TabletSCD26a39d3f-3f71-31b6-e063-6394a90a7b841
310534glibenclamide 2.5 MG Oral TabletSY26a39d3f-3f71-31b6-e063-6394a90a7b841
310534glibenclamide 2.5 MG Oral TabletSY03c1e0ae-6081-f9a6-e063-6294a90a6d871

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72241-039-0572241003905100 TABLET in 1 BOTTLE (72241-039-05) 100 tablet2021-10-050000-00-00NoNoCurrent
72241-039-1072241003910500 TABLET in 1 BOTTLE (72241-039-10) 500 tablet2021-10-050000-00-00NoNoCurrent
72241-039-11722410039111000 TABLET in 1 BOTTLE (72241-039-11) 1000 tablet2021-10-050000-00-00NoNoCurrent