Glyburide

Product NDC
72241-040
11-digit product format
722410040
Labeler code
72241
Product ID
72241-040_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
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
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
72241-040-05Glyburide100 in 1 BOTTLETABLET1002
72241-040-10Glyburide500 in 1 BOTTLETABLET5002
72241-040-11Glyburide1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72241-040-05EA - Each72241-040d83ef93c-7760-4882-b38e-32096afee29b12022-01-06
72241-040-10EA - Each72241-04075190b3a-4401-45fe-ba7b-0796fed80c3812022-01-06
72241-040-11EA - Each72241-0404385ace9-9164-44b6-8c0d-0323669fe7cf12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72241-040GLYBURIDE 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
310537glyBURIDE 5 MG Oral TabletPSN51cf08e2-8a2f-4bde-996f-f431f1a68abd6
310537glyburide 5 MG Oral TabletSCD51cf08e2-8a2f-4bde-996f-f431f1a68abd6
310537glibenclamide 5 MG Oral TabletSY51cf08e2-8a2f-4bde-996f-f431f1a68abd6
310537glyBURIDE 5 MG Oral TabletPSNcf21c8c0-7247-4d5b-97f8-ae40161446424
310537glyBURIDE 5 MG Oral TabletPSNd090f978-b1a5-4db7-951d-3f32dd06966c4
310537glyburide 5 MG Oral TabletSCDd090f978-b1a5-4db7-951d-3f32dd06966c4
310537glyburide 5 MG Oral TabletSCDcf21c8c0-7247-4d5b-97f8-ae40161446424
310537glibenclamide 5 MG Oral TabletSYcf21c8c0-7247-4d5b-97f8-ae40161446424
310537glibenclamide 5 MG Oral TabletSYd090f978-b1a5-4db7-951d-3f32dd06966c4
310537glyBURIDE 5 MG Oral TabletPSN524eec41-37ee-419a-b7a1-d23e888ae6ab3
310537glyburide 5 MG Oral TabletSCD524eec41-37ee-419a-b7a1-d23e888ae6ab3
310537glibenclamide 5 MG Oral TabletSY524eec41-37ee-419a-b7a1-d23e888ae6ab3
197737glyBURIDE 1.25 MG Oral TabletPSNa5de0ef6-4c8b-40ab-b0ed-2003a80867502
310534glyBURIDE 2.5 MG Oral TabletPSNa5de0ef6-4c8b-40ab-b0ed-2003a80867502
310537glyBURIDE 5 MG Oral TabletPSNffd31d06-6011-34e2-e053-6394a90a437f2
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 TabletSCDffd31d06-6011-34e2-e053-6394a90a437f2
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
310537glibenclamide 5 MG Oral TabletSYffd31d06-6011-34e2-e053-6394a90a437f2
310537glyBURIDE 5 MG Oral TabletPSN03c3925a-c810-6731-e063-6294a90a59391
310537glyBURIDE 5 MG Oral TabletPSNdb074991-1267-454a-8b1d-b6f52e2132cc1
310537glyburide 5 MG Oral TabletSCDdb074991-1267-454a-8b1d-b6f52e2132cc1
310537glyburide 5 MG Oral TabletSCD03c3925a-c810-6731-e063-6294a90a59391
310537glibenclamide 5 MG Oral TabletSYdb074991-1267-454a-8b1d-b6f52e2132cc1
310537glibenclamide 5 MG Oral TabletSY03c3925a-c810-6731-e063-6294a90a59391

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72241-040-0572241004005100 TABLET in 1 BOTTLE (72241-040-05) 100 tablet2021-10-050000-00-00NoNoCurrent
72241-040-1072241004010500 TABLET in 1 BOTTLE (72241-040-10) 500 tablet2021-10-050000-00-00NoNoCurrent
72241-040-11722410040111000 TABLET in 1 BOTTLE (72241-040-11) 1000 tablet2021-10-050000-00-00NoNoCurrent