Glyburide

Product NDC
66116-360
11-digit product format
661160360
Labeler code
66116
Product ID
66116-360_a53e29b3-7436-419f-ad6c-0a805d97ab1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
MedVantx, Inc.
Application
ANDA074388
Marketing category
ANDA
Marketing start
2011-07-18
Marketing end
0000-00-00
Substance
GLYBURIDE
Active strength
5 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
66116-360-602019-11-13C16284748780-197449f38-b52b-f6ea-e053-dbdaa90aa703GLYBURIDE TABLETS, USP 1.25, 2.5, and 5 mg 8342 8343 8344 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66116-360-60Glyburide60 in 1 BOTTLETABLET601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYBURIDEACTIVE INGREDIENTSX6K58TVWCGLYBURIDE TABLET [MEDVANTX, INC.]1
GLYBURIDEACTIVE MOIETYSX6K58TVWCGLYBURIDE TABLET [MEDVANTX, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLYBURIDE TABLET [MEDVANTX, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLYBURIDE TABLET [MEDVANTX, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLYBURIDE TABLET [MEDVANTX, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLYBURIDE TABLET [MEDVANTX, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GLYBURIDE TABLET [MEDVANTX, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLYBURIDE TABLET [MEDVANTX, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGLYBURIDE TABLET [MEDVANTX, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66116-360GLYBURIDE TABLET [MEDVANTX, INC.]1Legacy NDC, 1 package rows20111114_a53e29b3-7436-419f-ad6c-0a805d97ab1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310537glyBURIDE 5 MG Oral TabletPSNa53e29b3-7436-419f-ad6c-0a805d97ab1a1
310537glyburide 5 MG Oral TabletSCDa53e29b3-7436-419f-ad6c-0a805d97ab1a1
310537glibenclamide 5 MG Oral TabletSYa53e29b3-7436-419f-ad6c-0a805d97ab1a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66116-360-606611603606060 in 1 BOTTLEHistorical