Glyburide

Product NDC
0121-0931
11-digit product format
001210931
Labeler code
0121
Product ID
0121-0931_bb1c127b-43e9-1772-e053-2995a90a03ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA206483
Marketing category
ANDA
Marketing start
2021-01-01
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
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0931-90EA - Each0121-0931bba1dfc3-f07e-4d2c-8ea9-f360a0039c7212021-02-05
0121-0931-92EA - Each0121-0931fa96e748-ef90-4de9-a42c-597e25b7d4c612021-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310537glyBURIDE 5 MG Oral TabletPSNc23cfac8-bfa5-95f4-e053-2a95a90aab0f1
310537glyburide 5 MG Oral TabletSCDc23cfac8-bfa5-95f4-e053-2a95a90aab0f1
310537glibenclamide 5 MG Oral TabletSYc23cfac8-bfa5-95f4-e053-2a95a90aab0f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0931-9000121093190100 TABLET in 1 BOTTLE (0121-0931-90) 100 tablet2021-01-010000-00-00NoNoCurrent
0121-0931-92001210931921000 TABLET in 1 BOTTLE (0121-0931-92) 1000 tablet2021-01-010000-00-00NoNoCurrent