Glyburide

Product NDC
50090-7408
11-digit product format
500907408
Labeler code
50090
Product ID
50090-7408_7a95fee8-f1a8-475e-94a3-9b79ba87fac7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203379
Marketing category
ANDA
Marketing start
2021-10-05
Substance
GLYBURIDE
Active strength
2.5 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
GLYBURIDE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSX6K58TVWC
Rxcui310534

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
50090-7408-0Glyburide30 in 1 BOTTLETABLET305
50090-7408-2Glyburide200 in 1 BOTTLETABLET2005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7408-0EA - Each50090-7408ee3878b9-ff55-41bf-a569-5ec8e1321a3712024-12-10
50090-7408-2EA - Each50090-74084345aa21-b4bf-4db4-8fd0-894aced0834a12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7408GLYBURIDE TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, 2 package rows20241030_676c0e45-0aa2-4060-ad18-67abb9873a50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310534glyBURIDE 2.5 MG Oral TabletPSN676c0e45-0aa2-4060-ad18-67abb9873a505
310534glyburide 2.5 MG Oral TabletSCD676c0e45-0aa2-4060-ad18-67abb9873a505
310534glibenclamide 2.5 MG Oral TabletSY676c0e45-0aa2-4060-ad18-67abb9873a505

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7408-05009074080030 TABLET in 1 BOTTLE (50090-7408-0) 30 tablet2024-10-24NoNoCurrent
50090-7408-250090740802200 TABLET in 1 BOTTLE (50090-7408-2) 200 tablet2024-10-24NoNoCurrent