Glyburide

Product NDC
68071-2402
11-digit product format
680712402
Labeler code
68071
Product ID
68071-2402_c23cfac8-bfa4-95f4-e053-2a95a90aab0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA206483
Marketing category
ANDA
Marketing start
2021-01-01
Marketing end
0000-00-00
Substance
GLYBURIDE
Active strength
5 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
68071-2402-3Glyburide30 in 1 BOTTLETABLET301
68071-2402-6Glyburide60 in 1 BOTTLETABLET601
68071-2402-9Glyburide90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2402GLYBURIDE TABLET [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 3 package rows20210515_c23cfac8-bfa5-95f4-e053-2a95a90aab0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310537glyBURIDE 5 MG Oral TabletPSNc23cfac8-bfa5-95f4-e053-2a95a90aab0f1
310537glyburide 5 MG Oral TabletSCDc23cfac8-bfa5-95f4-e053-2a95a90aab0f1
310537glibenclamide 5 MG Oral TabletSYc23cfac8-bfa5-95f4-e053-2a95a90aab0f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2402-36807124020330 TABLET in 1 BOTTLE (68071-2402-3) 30 tablet2021-05-130000-00-00NoNoCurrent
68071-2402-66807124020660 TABLET in 1 BOTTLE (68071-2402-6) 60 tablet2021-05-130000-00-00NoNoCurrent
68071-2402-96807124020990 TABLET in 1 BOTTLE (68071-2402-9) 90 tablet2021-05-130000-00-00NoNoCurrent