FDA.reportPublic FDA data

GLYBURIDE

Product NDC
23155-056
11-digit product format
231550056
Labeler code
23155
Product ID
23155-056_98ed9f46-1633-4f82-bd51-ff87b0157871
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLYBURIDE
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA090937
Marketing category
ANDA
Marketing start
2010-10-05
Substance
GLYBURIDE
Active strength
1.25 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
GLYBURIDE1.25 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
23155-056-01GLYBURIDE100 in 1 BOTTLETABLET10012
23155-056-10GLYBURIDE1000 in 1 BOTTLETABLET100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-056-01EA - Each23155-0563dee511a-a261-48e7-93a5-98cc956a3dcf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYBURIDEACTIVE INGREDIENTSX6K58TVWCGLYBURIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
GLYBURIDEACTIVE MOIETYSX6K58TVWCGLYBURIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLYBURIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLYBURIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGLYBURIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLYBURIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLYBURIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-056GLYBURIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 2 package rows20241215_33418bba-c5ea-4c0f-9d28-31dc2724c6c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197737glyBURIDE 1.25 MG Oral TabletPSN33418bba-c5ea-4c0f-9d28-31dc2724c6c312
310534glyBURIDE 2.5 MG Oral TabletPSN33418bba-c5ea-4c0f-9d28-31dc2724c6c312
310537glyBURIDE 5 MG Oral TabletPSN33418bba-c5ea-4c0f-9d28-31dc2724c6c312
197737glyburide 1.25 MG Oral TabletSCD33418bba-c5ea-4c0f-9d28-31dc2724c6c312
310534glyburide 2.5 MG Oral TabletSCD33418bba-c5ea-4c0f-9d28-31dc2724c6c312
310537glyburide 5 MG Oral TabletSCD33418bba-c5ea-4c0f-9d28-31dc2724c6c312
197737glibenclamide 1.25 MG Oral TabletSY33418bba-c5ea-4c0f-9d28-31dc2724c6c312
310534glibenclamide 2.5 MG Oral TabletSY33418bba-c5ea-4c0f-9d28-31dc2724c6c312
310537glibenclamide 5 MG Oral TabletSY33418bba-c5ea-4c0f-9d28-31dc2724c6c312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-056-0123155005601100 TABLET in 1 BOTTLE (23155-056-01) 100 tablet2010-10-050000-00-00NoNoCurrent
23155-056-10231550056101000 TABLET in 1 BOTTLE (23155-056-10) 1000 tablet2010-10-050000-00-00NoNoCurrent