Glyburide

Product NDC
82804-150
11-digit product format
828040150
Labeler code
82804
Product ID
82804-150_7378c94f-e2fc-4990-977b-9087a3789e91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA074388
Marketing category
ANDA
Marketing start
1995-08-30
Substance
GLYBURIDE
Active strength
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
GLYBURIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSX6K58TVWC
Rxcui310537

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
82804-150-00Glyburide100 in 1 BOTTLETABLET1002
82804-150-30Glyburide30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-150GLYBURIDE TABLET [PROFICIENT RX LP]1Current NDC, 2 package rows20240927_6f65131c-90df-45ab-95fb-c36f411c6fbe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310537glyBURIDE 5 MG Oral TabletPSN6f65131c-90df-45ab-95fb-c36f411c6fbe2
310537glyburide 5 MG Oral TabletSCD6f65131c-90df-45ab-95fb-c36f411c6fbe2
310537glibenclamide 5 MG Oral TabletSY6f65131c-90df-45ab-95fb-c36f411c6fbe2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-150-0082804015000100 TABLET in 1 BOTTLE (82804-150-00) 100 tablet2024-09-24NoNoCurrent
82804-150-308280401503030 TABLET in 1 BOTTLE (82804-150-30) 30 tablet2025-07-18NoNoCurrent