Glyburide

Product NDC
67046-1620
11-digit product format
670461620
Labeler code
67046
Product ID
67046-1620_4573af53-70f9-b5d7-e063-6294a90af2e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA074388
Marketing category
ANDA
Marketing start
2025-12-08
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
67046-1620-3Glyburide30 in 1 BLISTER PACKTABLET301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310534glyBURIDE 2.5 MG Oral TabletPSN4573af7f-3c71-e323-e063-6394a90aa9eb1
310534glyburide 2.5 MG Oral TabletSCD4573af7f-3c71-e323-e063-6394a90aa9eb1
310534glibenclamide 2.5 MG Oral TabletSY4573af7f-3c71-e323-e063-6394a90aa9eb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1620-36704616200330 TABLET in 1 BLISTER PACK (67046-1620-3) 30 tablet2025-12-08NoNoCurrent