Glyburide

Product NDC
71209-009
11-digit product format
712090009
Labeler code
71209
Product ID
71209-009_54461b9f-3232-47ce-9e73-a26ab1e44702
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
Cadila Pharmaceuticals Limited
Application
ANDA203379
Marketing category
ANDA
Marketing start
2014-04-26
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
71209-009-05Glyburide100 in 1 BOTTLETABLET1009
71209-009-11Glyburide1000 in 1 BOTTLETABLET10009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71209-009GLYBURIDE TABLET [CADILA PHARMACEUTICALS LIMITED]9Current NDC, Legacy NDC, 2 package rows20221230_ea7a055b-64f0-46bf-aa8e-4a2ef5c3c035.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197737glyBURIDE 1.25 MG Oral TabletPSNea7a055b-64f0-46bf-aa8e-4a2ef5c3c0359
310534glyBURIDE 2.5 MG Oral TabletPSNea7a055b-64f0-46bf-aa8e-4a2ef5c3c0359
310537glyBURIDE 5 MG Oral TabletPSNea7a055b-64f0-46bf-aa8e-4a2ef5c3c0359
197737glyburide 1.25 MG Oral TabletSCDea7a055b-64f0-46bf-aa8e-4a2ef5c3c0359
310534glyburide 2.5 MG Oral TabletSCDea7a055b-64f0-46bf-aa8e-4a2ef5c3c0359
310537glyburide 5 MG Oral TabletSCDea7a055b-64f0-46bf-aa8e-4a2ef5c3c0359
197737glibenclamide 1.25 MG Oral TabletSYea7a055b-64f0-46bf-aa8e-4a2ef5c3c0359
310534glibenclamide 2.5 MG Oral TabletSYea7a055b-64f0-46bf-aa8e-4a2ef5c3c0359
310537glibenclamide 5 MG Oral TabletSYea7a055b-64f0-46bf-aa8e-4a2ef5c3c0359

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71209-009-0571209000905100 TABLET in 1 BOTTLE (71209-009-05) 100 tablet2014-04-260000-00-00NoNoCurrent
71209-009-11712090009111000 TABLET in 1 BOTTLE (71209-009-11) 1000 tablet2014-04-260000-00-00NoNoCurrent