FDA.reportPublic FDA data

glyburide

Product NDC
68382-657
11-digit product format
683820657
Labeler code
68382
Product ID
68382-657_1ff75368-1bfd-4173-b0aa-18eca2c97a4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glyburide
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA206749
Marketing category
ANDA
Marketing start
2016-06-02
Substance
GLYBURIDE
Active strength
2.5 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
glyburide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYBURIDE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSX6K58TVWC
Rxcui197737, 310534, 310537

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-657-01glyburide100 in 1 BOTTLETABLET1003
68382-657-05glyburide500 in 1 BOTTLETABLET5003
68382-657-06glyburide30 in 1 BOTTLETABLET303
68382-657-10glyburide1000 in 1 BOTTLETABLET10003
68382-657-16glyburide90 in 1 BOTTLETABLET903
68382-657-30glyburide10 in 1 BLISTER PACKTABLET103
68382-657-77glyburide10 in 1 CARTONTABLET103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-657-01EA - Each68382-657ddb00618-f432-447a-b0ab-cee90da5e95012016-08-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-657GLYBURIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3Current NDC, Legacy NDC, 7 package rows20221117_87781ea8-62ec-483c-a4dd-8c965ce59485.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197737glyBURIDE 1.25 MG Oral TabletPSN87781ea8-62ec-483c-a4dd-8c965ce594853
310534glyBURIDE 2.5 MG Oral TabletPSN87781ea8-62ec-483c-a4dd-8c965ce594853
310537glyBURIDE 5 MG Oral TabletPSN87781ea8-62ec-483c-a4dd-8c965ce594853
197737glyburide 1.25 MG Oral TabletSCD87781ea8-62ec-483c-a4dd-8c965ce594853
310534glyburide 2.5 MG Oral TabletSCD87781ea8-62ec-483c-a4dd-8c965ce594853
310537glyburide 5 MG Oral TabletSCD87781ea8-62ec-483c-a4dd-8c965ce594853
197737glibenclamide 1.25 MG Oral TabletSY87781ea8-62ec-483c-a4dd-8c965ce594853
310534glibenclamide 2.5 MG Oral TabletSY87781ea8-62ec-483c-a4dd-8c965ce594853
310537glibenclamide 5 MG Oral TabletSY87781ea8-62ec-483c-a4dd-8c965ce594853

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-657-0168382065701100 TABLET in 1 BOTTLE (68382-657-01) 100 tablet2016-06-020000-00-00NoNoCurrent
68382-657-0568382065705500 TABLET in 1 BOTTLE (68382-657-05) 500 tablet2016-06-020000-00-00NoNoCurrent
68382-657-066838206570630 TABLET in 1 BOTTLE (68382-657-06) 30 tablet2016-06-020000-00-00NoNoCurrent
68382-657-10683820657101000 TABLET in 1 BOTTLE (68382-657-10) 1000 tablet2016-06-020000-00-00NoNoCurrent
68382-657-166838206571690 TABLET in 1 BOTTLE (68382-657-16) 90 tablet2016-06-020000-00-00NoNoCurrent
68382-657-306838206573010 in 1 BLISTER PACKHistorical
68382-657-776838206577710 BLISTER PACK in 1 CARTON (68382-657-77) / 10 TABLET in 1 BLISTER PACK (68382-657-30) 10 blister pack2016-06-020000-00-00NoNoCurrent