GLYBURIDE

Product NDC
61919-330
11-digit product format
619190330
Labeler code
61919
Product ID
61919-330_9c972291-71bd-b588-e053-2995a90ab657
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLYBURIDE
Dosage form
TABLET
Route
ORAL
Labeler
DirectRX
Application
ANDA090937
Marketing category
ANDA
Marketing start
2015-12-03
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
2021-12-31
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
61919-330-302023-01-30C16284748780-1f386c649-a046-0266-e053-dadaa90a7c1aGLYBURIDE
61919-330-602023-01-30C16284748780-1f386c649-a046-0266-e053-dadaa90a7c1aGLYBURIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-330-30GLYBURIDE30 in 1 BOTTLETABLET303
61919-330-60GLYBURIDE60 in 1 BOTTLETABLET603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-330-30EA - Each61919-330b19a0057-7c03-4895-8051-8913689e874d12016-02-04
61919-330-60EA - Each61919-330a0496cb3-019a-4682-a437-49cdd08a753c12016-02-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-330GLYBURIDE TABLET [DIRECTRX]3Legacy NDC, 2 package rows20200130_25ff45f9-5da8-0644-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310534glyBURIDE 2.5 MG Oral TabletPSN25ff45f9-5da8-0644-e054-00144ff8d46c3
310534glyburide 2.5 MG Oral TabletSCD25ff45f9-5da8-0644-e054-00144ff8d46c3
310534glibenclamide 2.5 MG Oral TabletSY25ff45f9-5da8-0644-e054-00144ff8d46c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-330-306191903303030 TABLET in 1 BOTTLE (61919-330-30) 30 tablet2015-12-030000-00-00NoNoCurrent
61919-330-606191903306060 TABLET in 1 BOTTLE (61919-330-60) 60 tablet2015-12-030000-00-00NoNoCurrent