Glyburide

Product NDC
0115-1743
11-digit product format
001151743
Labeler code
0115
Product ID
0115-1743_60f84d8c-eabb-40f0-aa63-56c62c46fe43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA206079
Marketing category
ANDA
Marketing start
2016-06-01
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
2021-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-1743-01Glyburide100 in 1 BOTTLETABLET1004
0115-1743-03Glyburide1000 in 1 BOTTLETABLET10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1743GLYBURIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]4Legacy NDC, 2 package rows20201230_5c391b11-68e9-4040-8408-56b43ee853f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197737glyBURIDE 1.25 MG Oral TabletPSN5c391b11-68e9-4040-8408-56b43ee853f54
310534glyBURIDE 2.5 MG Oral TabletPSN5c391b11-68e9-4040-8408-56b43ee853f54
310537glyBURIDE 5 MG Oral TabletPSN5c391b11-68e9-4040-8408-56b43ee853f54
197737glyburide 1.25 MG Oral TabletSCD5c391b11-68e9-4040-8408-56b43ee853f54
310534glyburide 2.5 MG Oral TabletSCD5c391b11-68e9-4040-8408-56b43ee853f54
310537glyburide 5 MG Oral TabletSCD5c391b11-68e9-4040-8408-56b43ee853f54
197737glibenclamide 1.25 MG Oral TabletSY5c391b11-68e9-4040-8408-56b43ee853f54
310534glibenclamide 2.5 MG Oral TabletSY5c391b11-68e9-4040-8408-56b43ee853f54
310537glibenclamide 5 MG Oral TabletSY5c391b11-68e9-4040-8408-56b43ee853f54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-1743-0100115174301100 TABLET in 1 BOTTLE (0115-1743-01) 100 tablet2016-06-010000-00-00NoNoCurrent
0115-1743-03001151743031000 TABLET in 1 BOTTLE (0115-1743-03) 1000 tablet2016-06-010000-00-00NoNoCurrent