Glyburide

Product NDC
76333-154
11-digit product format
763330154
Labeler code
76333
Product ID
76333-154_79776664-132e-45ca-9d74-511ab4edc8ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
Orient Pharma Co., Ltd.
Application
ANDA206483
Marketing category
ANDA
Marketing start
2019-02-26
Marketing end
0000-00-00
Substance
GLYBURIDE
Active strength
1 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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
76333-154-11Glyburide100 in 1 BOTTLETABLET1002
76333-154-12Glyburide1000 in 1 BOTTLETABLET10002
76333-154-13Glyburide500 in 1 BOTTLETABLET5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76333-154GLYBURIDE TABLET [ORIENT PHARMA CO., LTD.]2Legacy NDC, 3 package rows20190226_3152f552-f0ac-4603-8110-3112e4d053b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197737glyBURIDE 1.25 MG Oral TabletPSN3152f552-f0ac-4603-8110-3112e4d053b22
310534glyBURIDE 2.5 MG Oral TabletPSN3152f552-f0ac-4603-8110-3112e4d053b22
310537glyBURIDE 5 MG Oral TabletPSN3152f552-f0ac-4603-8110-3112e4d053b22
197737glyburide 1.25 MG Oral TabletSCD3152f552-f0ac-4603-8110-3112e4d053b22
310534glyburide 2.5 MG Oral TabletSCD3152f552-f0ac-4603-8110-3112e4d053b22
310537glyburide 5 MG Oral TabletSCD3152f552-f0ac-4603-8110-3112e4d053b22
197737glibenclamide 1.25 MG Oral TabletSY3152f552-f0ac-4603-8110-3112e4d053b22
310534glibenclamide 2.5 MG Oral TabletSY3152f552-f0ac-4603-8110-3112e4d053b22
310537glibenclamide 5 MG Oral TabletSY3152f552-f0ac-4603-8110-3112e4d053b22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76333-154-1176333015411100 TABLET in 1 BOTTLE (76333-154-11) 100 tablet2019-02-260000-00-00NoNoCurrent
76333-154-12763330154121000 TABLET in 1 BOTTLE (76333-154-12) 1000 tablet2019-02-260000-00-00NoNoCurrent
76333-154-1376333015413500 TABLET in 1 BOTTLE (76333-154-13) 500 tablet2019-02-260000-00-00NoNoCurrent