Glyburide

Product NDC
10544-232
11-digit product format
105440232
Labeler code
10544
Product ID
10544-232_11925cb1-aa2a-2f64-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA090937
Marketing category
ANDA
Marketing start
2013-11-15
Marketing end
0000-00-00
Substance
GLYBURIDE
Active strength
3 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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
10544-232-302020-01-31C16284748780-19d75b9d0-b281-f424-e053-dadaa90a57ceGlyburide Tablets, USP 1.25 mg, 2.5 mg and 5 mg For Oral Use

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-232-30Glyburide30 in 1 BOTTLETABLET301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYBURIDEACTIVE INGREDIENTSX6K58TVWCGLYBURIDE TABLET [BLENHEIM PHARMACAL, INC.]1
GLYBURIDEACTIVE MOIETYSX6K58TVWCGLYBURIDE TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLYBURIDE TABLET [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLYBURIDE TABLET [BLENHEIM PHARMACAL, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGLYBURIDE TABLET [BLENHEIM PHARMACAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLYBURIDE TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLYBURIDE TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-232GLYBURIDE TABLET [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 1 package rows20150318_11925cb1-aa29-2f64-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310534glyBURIDE 2.5 MG Oral TabletPSN11925cb1-aa29-2f64-e054-00144ff88e881
310537glyBURIDE 5 MG Oral TabletPSN11925cb1-aa29-2f64-e054-00144ff88e881
310534glyburide 2.5 MG Oral TabletSCD11925cb1-aa29-2f64-e054-00144ff88e881
310537glyburide 5 MG Oral TabletSCD11925cb1-aa29-2f64-e054-00144ff88e881
310534glibenclamide 2.5 MG Oral TabletSY11925cb1-aa29-2f64-e054-00144ff88e881
310537glibenclamide 5 MG Oral TabletSY11925cb1-aa29-2f64-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-232-301054402323030 in 1 BOTTLEHistorical