glyburide

Product NDC
65841-832
11-digit product format
658410832
Labeler code
65841
Product ID
65841-832_0450d056-3523-44c3-a4cf-f4557e520ce5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glyburide
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA206749
Marketing category
ANDA
Marketing start
2016-06-02
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
65841-832-01glyburide100 in 1 BOTTLETABLET1003
65841-832-05glyburide500 in 1 BOTTLETABLET5003
65841-832-06glyburide30 in 1 BOTTLETABLET303
65841-832-10glyburide1000 in 1 BOTTLETABLET10003
65841-832-16glyburide90 in 1 BOTTLETABLET903
65841-832-30glyburide10 in 1 BLISTER PACKTABLET103
65841-832-77glyburide10 in 1 CARTONTABLET103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-832GLYBURIDE TABLET [ZYDUS LIFESCIENCES LIMITED]3Current NDC, Legacy NDC, 7 package rows20221117_5d0e406f-285d-4716-8971-82f665345517.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197737glyBURIDE 1.25 MG Oral TabletPSN5d0e406f-285d-4716-8971-82f6653455173
310534glyBURIDE 2.5 MG Oral TabletPSN5d0e406f-285d-4716-8971-82f6653455173
310537glyBURIDE 5 MG Oral TabletPSN5d0e406f-285d-4716-8971-82f6653455173
197737glyburide 1.25 MG Oral TabletSCD5d0e406f-285d-4716-8971-82f6653455173
310534glyburide 2.5 MG Oral TabletSCD5d0e406f-285d-4716-8971-82f6653455173
310537glyburide 5 MG Oral TabletSCD5d0e406f-285d-4716-8971-82f6653455173
197737glibenclamide 1.25 MG Oral TabletSY5d0e406f-285d-4716-8971-82f6653455173
310534glibenclamide 2.5 MG Oral TabletSY5d0e406f-285d-4716-8971-82f6653455173
310537glibenclamide 5 MG Oral TabletSY5d0e406f-285d-4716-8971-82f6653455173

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-832-0165841083201100 TABLET in 1 BOTTLE (65841-832-01) 100 tablet2016-06-020000-00-00NoNoCurrent
65841-832-0565841083205500 TABLET in 1 BOTTLE (65841-832-05) 500 tablet2016-06-020000-00-00NoNoCurrent
65841-832-066584108320630 TABLET in 1 BOTTLE (65841-832-06) 30 tablet2016-06-020000-00-00NoNoCurrent
65841-832-10658410832101000 TABLET in 1 BOTTLE (65841-832-10) 1000 tablet2016-06-020000-00-00NoNoCurrent
65841-832-166584108321690 TABLET in 1 BOTTLE (65841-832-16) 90 tablet2016-06-020000-00-00NoNoCurrent
65841-832-306584108323010 in 1 BLISTER PACKHistorical
65841-832-776584108327710 BLISTER PACK in 1 CARTON (65841-832-77) / 10 TABLET in 1 BLISTER PACK (65841-832-30) 10 blister pack2016-06-020000-00-00NoNoCurrent