Glyburide

Product NDC
68071-4142
11-digit product format
680714142
Labeler code
68071
Product ID
68071-4142_c21527be-e32c-4f70-e053-2995a90a8630
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmceuticals,Inc.
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
2022-12-31
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
68071-4142-3Glyburide30 in 1 BOTTLETABLET302
68071-4142-6Glyburide60 in 1 BOTTLETABLET602
68071-4142-9Glyburide90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4142GLYBURIDE TABLET [NUCARE PHARMCEUTICALS,INC.]2Legacy NDC, 3 package rows20210512_5cdfba1e-7179-a2ee-e053-2991aa0adce9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310534glyBURIDE 2.5 MG Oral TabletPSN5cdfba1e-7179-a2ee-e053-2991aa0adce92
310534glyburide 2.5 MG Oral TabletSCD5cdfba1e-7179-a2ee-e053-2991aa0adce92
310534glibenclamide 2.5 MG Oral TabletSY5cdfba1e-7179-a2ee-e053-2991aa0adce92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4142-36807141420330 TABLET in 1 BOTTLE (68071-4142-3) 30 tablet2017-10-310000-00-00NoNoCurrent
68071-4142-66807141420660 TABLET in 1 BOTTLE (68071-4142-6) 60 tablet2017-10-310000-00-00NoNoCurrent
68071-4142-96807141420990 TABLET in 1 BOTTLE (68071-4142-9) 90 tablet2017-10-310000-00-00NoNoCurrent