Glyburide

Product NDC
50090-3429
11-digit product format
500903429
Labeler code
50090
Product ID
50090-3429_3a55550b-c8a5-4aa4-961e-3ffa88c515d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA074388
Marketing category
ANDA
Marketing start
1995-08-30
Marketing end
0000-00-00
Substance
GLYBURIDE
Active strength
5 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3429-1Glyburide100 in 1 BOTTLETABLET1005
50090-3429-8Glyburide200 in 1 BOTTLE, PLASTICTABLET2005
50090-3429-9Glyburide90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3429-1EA - Each50090-342966d8cf2c-3dbb-40ef-806c-c8bb3d8ade2112019-05-02
50090-3429-9EA - Each50090-342966d7b3e1-3123-4362-bd55-c3e079c5fb0112019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3429GLYBURIDE TABLET [A-S MEDICATION SOLUTIONS]5Legacy NDC, 3 package rows20210115_387dd732-a638-4b4b-b3d3-ee2c541923de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310537glyBURIDE 5 MG Oral TabletPSN387dd732-a638-4b4b-b3d3-ee2c541923de5
310537glyburide 5 MG Oral TabletSCD387dd732-a638-4b4b-b3d3-ee2c541923de5
310537glibenclamide 5 MG Oral TabletSY387dd732-a638-4b4b-b3d3-ee2c541923de5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3429-150090342901100 TABLET in 1 BOTTLE (50090-3429-1) 100 tablet2018-04-060000-00-00NoNoCurrent
50090-3429-850090342908200 TABLET in 1 BOTTLE, PLASTIC (50090-3429-8) 200 tablet2014-11-280000-00-00NoNoCurrent
50090-3429-95009034290990 TABLET in 1 BOTTLE (50090-3429-9) 90 tablet2018-04-050000-00-00NoNoCurrent