glyBURIDE

Product NDC
52817-122
11-digit product format
528170122
Labeler code
52817
Product ID
52817-122_b7928c2d-1e2e-a219-e053-2995a90aedee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glyBURIDE
Dosage form
TABLET
Route
ORAL
Labeler
TruPharma, LLC
Application
ANDA203581
Marketing category
ANDA
Marketing start
2016-06-01
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
2021-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-122-00EA - Each52817-122c55b447a-daca-4e46-9800-a627bb6bcc4912016-09-02
52817-122-10EA - Each52817-122e59d8b86-80ce-4553-970d-886f131d719212016-09-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310537glyBURIDE 5 MG Oral TabletPSN7f45c4ad-aa60-40d7-81f7-90c256f3df9f2
310537glyburide 5 MG Oral TabletSCD7f45c4ad-aa60-40d7-81f7-90c256f3df9f2
310537glibenclamide 5 MG Oral TabletSY7f45c4ad-aa60-40d7-81f7-90c256f3df9f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52817-122-00528170122001000 TABLET in 1 BOTTLE (52817-122-00) 1000 tablet2016-06-010000-00-00NoNoCurrent
52817-122-1052817012210100 TABLET in 1 BOTTLE (52817-122-10) 100 tablet2016-06-010000-00-00NoNoCurrent