Glyburide

Product NDC
68071-2189
11-digit product format
680712189
Labeler code
68071
Product ID
68071-2189_4b6b2ce1-e34a-3921-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA074388
Marketing category
ANDA
Marketing start
1995-08-30
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2189-3Glyburide30 in 1 BOTTLETABLET304
68071-2189-6Glyburide60 in 1 BOTTLETABLET604
68071-2189-8Glyburide180 in 1 BOTTLETABLET1804
68071-2189-9Glyburide90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2189GLYBURIDE TABLET [NUCARE PHARMACEUTICALS, INC.]4Legacy NDC, 4 package rows20230621_4b6b2ce1-e349-3921-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310534glyBURIDE 2.5 MG Oral TabletPSN4b6b2ce1-e349-3921-e054-00144ff8d46c4
310534glyburide 2.5 MG Oral TabletSCD4b6b2ce1-e349-3921-e054-00144ff8d46c4
310534glibenclamide 2.5 MG Oral TabletSY4b6b2ce1-e349-3921-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68071-2189-36807121890330 in 1 BOTTLEHistorical
68071-2189-66807121890660 in 1 BOTTLEHistorical
68071-2189-868071218908180 in 1 BOTTLEHistorical
68071-2189-96807121890990 in 1 BOTTLEHistorical