Glyburide

Product NDC
43353-659
11-digit product format
433530659
Labeler code
43353
Product ID
43353-659_450c5c16-46d8-4867-8f8b-c84dd8515761
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glyburide
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA017532
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1984-05-01
Marketing end
0000-00-00
Substance
GLYBURIDE
Active strength
3 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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
43353-659-602023-01-30C16284748780-1f386c649-9e54-0266-e053-dadaa90a7c1aGlyburide Tablets USP
43353-659-802023-01-30C16284748780-1f386c649-9e54-0266-e053-dadaa90a7c1aGlyburide Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-659-60Glyburide90 in 1 BOTTLE, PLASTICTABLET903
43353-659-80Glyburide180 in 1 BOTTLE, PLASTICTABLET1803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-659GLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Legacy NDC, 2 package rows20191224_820400e2-d340-416d-9015-c56357780362.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
43353-659-604335306596090 TABLET in 1 BOTTLE, PLASTIC (43353-659-60) 90 tablet2010-09-240000-00-00NoNoCurrent
43353-659-8043353065980180 TABLET in 1 BOTTLE, PLASTIC (43353-659-80) 180 tablet2010-09-240000-00-00NoNoCurrent