Glyburide

Product NDC
61919-378
11-digit product format
619190378
Labeler code
61919
Product ID
61919-378_d61c96ef-dd5e-b68f-e053-2a95a90a7af6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA090937
Marketing category
ANDA
Marketing start
2019-01-15
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
61919-378-602020-01-31C16284748780-19d75b9cf-d061-f424-e053-dadaa90a57ceGLYBURIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-378-60GLYBURIDE60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-378-60EA - Each61919-378afb137c6-4ac2-4fb6-b341-d7647c2d3dc912016-02-04
61919-378-90EA - Each61919-378a11b2d1d-4f63-4f4c-a13b-23014702c5a612019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-378GLYBURIDE TABLET [DIRECTRX]1Legacy NDC, 1 package rows20151204_2615ee96-7a3d-5cde-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310537glyBURIDE 5 MG Oral TabletPSN2615ee96-7a3d-5cde-e054-00144ff8d46c1
310537glyburide 5 MG Oral TabletSCD2615ee96-7a3d-5cde-e054-00144ff8d46c1
310537glibenclamide 5 MG Oral TabletSY2615ee96-7a3d-5cde-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-378-606191903786060 in 1 BOTTLEHistorical
61919-378-906191903789090 TABLET in 1 BOTTLE (61919-378-90) 90 tablet2019-01-150000-00-00NoNoCurrent