Glyburide

Product NDC
21695-467
11-digit product format
216950467
Labeler code
21695
Product ID
21695-467_60cc988d-4175-4d7b-9021-299c46602a4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA076257
Marketing category
ANDA
Marketing start
2002-08-06
Marketing end
0000-00-00
Substance
GLYBURIDE
Active strength
3 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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
21695-467-30Glyburide30 in 1 BOTTLE, PLASTICTABLET301
21695-467-60Glyburide60 in 1 BOTTLE, PLASTICTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-467GLYBURIDE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20101119_60cc988d-4175-4d7b-9021-299c46602a4c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310534glyBURIDE 2.5 MG Oral TabletPSN60cc988d-4175-4d7b-9021-299c46602a4c1
310537glyBURIDE 5 MG Oral TabletPSN60cc988d-4175-4d7b-9021-299c46602a4c1
310534glyburide 2.5 MG Oral TabletSCD60cc988d-4175-4d7b-9021-299c46602a4c1
310537glyburide 5 MG Oral TabletSCD60cc988d-4175-4d7b-9021-299c46602a4c1
310534glibenclamide 2.5 MG Oral TabletSY60cc988d-4175-4d7b-9021-299c46602a4c1
310537glibenclamide 5 MG Oral TabletSY60cc988d-4175-4d7b-9021-299c46602a4c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-467-302169504673030 in 1 BOTTLE, PLASTICHistorical
21695-467-602169504676060 in 1 BOTTLE, PLASTICHistorical