glyBURIDE

Product NDC
50090-4215
11-digit product format
500904215
Labeler code
50090
Product ID
50090-4215_f549ac1d-5cdb-47be-b9ab-5816af6c2fa7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glyBURIDE
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203581
Marketing category
ANDA
Marketing start
2016-06-01
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
2020-12-31
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
50090-4215-22023-01-30C16284748780-1f386c649-c02f-0266-e053-dadaa90a7c1a7f45c4ad-aa60-40d7-81f7-90c256f3df9f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4215-2glyBURIDE60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4215GLYBURIDE TABLET [A-S MEDICATION SOLUTIONS]2Legacy NDC, 1 package rows20190612_7f45c4ad-aa60-40d7-81f7-90c256f3df9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310537glyBURIDE 5 MG Oral TabletPSN7f45c4ad-aa60-40d7-81f7-90c256f3df9f2
310537glyburide 5 MG Oral TabletSCD7f45c4ad-aa60-40d7-81f7-90c256f3df9f2
310537glibenclamide 5 MG Oral TabletSY7f45c4ad-aa60-40d7-81f7-90c256f3df9f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4215-25009042150260 TABLET in 1 BOTTLE (50090-4215-2) 60 tablet2019-03-250000-00-00NoNoCurrent