FDA.reportPublic FDA data

Glyburide

Product NDC
0093-9433
11-digit product format
000939433
Labeler code
0093
Product ID
0093-9433_84b83205-8813-494e-933e-a70697393744
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glyburide
Dosage form
TABLET
Route
ORAL
Labeler
TEVA Pharmaceuticals USA Inc
Application
NDA017532
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1984-05-01
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
0093-9433-01Glyburide100 in 1 BOTTLETABLET10013
0093-9433-05Glyburide500 in 1 BOTTLETABLET50013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-9433GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]13Current NDC, Legacy NDC, 2 package rows20210829_50d16f1d-c814-4411-8749-62561321ecce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197737glyBURIDE 1.25 MG Oral TabletPSN50d16f1d-c814-4411-8749-62561321ecce13
310534glyBURIDE 2.5 MG Oral TabletPSN50d16f1d-c814-4411-8749-62561321ecce13
310537glyBURIDE 5 MG Oral TabletPSN50d16f1d-c814-4411-8749-62561321ecce13
197737glyburide 1.25 MG Oral TabletSCD50d16f1d-c814-4411-8749-62561321ecce13
310534glyburide 2.5 MG Oral TabletSCD50d16f1d-c814-4411-8749-62561321ecce13
310537glyburide 5 MG Oral TabletSCD50d16f1d-c814-4411-8749-62561321ecce13
197737glibenclamide 1.25 MG Oral TabletSY50d16f1d-c814-4411-8749-62561321ecce13
310534glibenclamide 2.5 MG Oral TabletSY50d16f1d-c814-4411-8749-62561321ecce13
310537glibenclamide 5 MG Oral TabletSY50d16f1d-c814-4411-8749-62561321ecce13
197737glyBURIDE 1.25 MG Oral TabletPSN820400e2-d340-416d-9015-c563577803623
310534glyBURIDE 2.5 MG Oral TabletPSN820400e2-d340-416d-9015-c563577803623
310537glyBURIDE 5 MG Oral TabletPSN820400e2-d340-416d-9015-c563577803623
197737glyburide 1.25 MG Oral TabletSCD820400e2-d340-416d-9015-c563577803623
310534glyburide 2.5 MG Oral TabletSCD820400e2-d340-416d-9015-c563577803623
310537glyburide 5 MG Oral TabletSCD820400e2-d340-416d-9015-c563577803623
197737glibenclamide 1.25 MG Oral TabletSY820400e2-d340-416d-9015-c563577803623
310534glibenclamide 2.5 MG Oral TabletSY820400e2-d340-416d-9015-c563577803623
310537glibenclamide 5 MG Oral TabletSY820400e2-d340-416d-9015-c563577803623

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-9433-0100093943301100 TABLET in 1 BOTTLE (0093-9433-01) 100 tablet1984-05-010000-00-00NoNoCurrent
0093-9433-0500093943305500 TABLET in 1 BOTTLE (0093-9433-05) 500 tablet1984-05-010000-00-00NoNoCurrent