GLYBURIDE

Product NDC
68071-2589
11-digit product format
680712589
Labeler code
68071
Product ID
68071-2589_dd7c3e5c-bfc2-88f2-e053-2a95a90aeff2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLYBURIDE
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090937
Marketing category
ANDA
Marketing start
2010-10-05
Marketing end
0000-00-00
Substance
GLYBURIDE
Active strength
5 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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
68071-2589-62025-01-30C16284748780-12cef2736-a841-d83d-e063-dadaa90ab31fGlyburide Tablets, USP 1.25, 2.5, and 5 mg
68071-2589-92025-01-30C16284748780-12cef2736-a841-d83d-e063-dadaa90ab31fGlyburide Tablets, USP 1.25, 2.5, and 5 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2589-6GLYBURIDE60 in 1 BOTTLETABLET602
68071-2589-9GLYBURIDE90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2589GLYBURIDE TABLET [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 2 package rows20220426_d2ba6d99-9722-76d5-e053-2a95a90a6f50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310537glyBURIDE 5 MG Oral TabletPSNd2ba6d99-9722-76d5-e053-2a95a90a6f502
310537glyburide 5 MG Oral TabletSCDd2ba6d99-9722-76d5-e053-2a95a90a6f502
310537glibenclamide 5 MG Oral TabletSYd2ba6d99-9722-76d5-e053-2a95a90a6f502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2589-66807125890660 TABLET in 1 BOTTLE (68071-2589-6) 60 tablet2021-12-090000-00-00NoNoCurrent
68071-2589-96807125890990 TABLET in 1 BOTTLE (68071-2589-9) 90 tablet2021-12-090000-00-00NoNoCurrent