GLYBURIDE

Product NDC
62135-583
11-digit product format
621350583
Labeler code
62135
Product ID
62135-583_458a6ce1-673d-85c7-e063-6294a90a3577
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLYBURIDE
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA090937
Marketing category
ANDA
Marketing start
2010-10-05
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
62135-583-30GLYBURIDE30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-583GLYBURIDE TABLET [CHARTWELL RX, LLC]2Current NDC, 1 package rows20241030_7e661288-2d24-4403-86a1-754afa1d04ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197737glyBURIDE 1.25 MG Oral TabletPSN7e661288-2d24-4403-86a1-754afa1d04ff3
310534glyBURIDE 2.5 MG Oral TabletPSN7e661288-2d24-4403-86a1-754afa1d04ff3
310537glyBURIDE 5 MG Oral TabletPSN7e661288-2d24-4403-86a1-754afa1d04ff3
197737glyburide 1.25 MG Oral TabletSCD7e661288-2d24-4403-86a1-754afa1d04ff3
310534glyburide 2.5 MG Oral TabletSCD7e661288-2d24-4403-86a1-754afa1d04ff3
310537glyburide 5 MG Oral TabletSCD7e661288-2d24-4403-86a1-754afa1d04ff3
197737glibenclamide 1.25 MG Oral TabletSY7e661288-2d24-4403-86a1-754afa1d04ff3
310534glibenclamide 2.5 MG Oral TabletSY7e661288-2d24-4403-86a1-754afa1d04ff3
310537glibenclamide 5 MG Oral TabletSY7e661288-2d24-4403-86a1-754afa1d04ff3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-583-306213505833030 TABLET in 1 BOTTLE (62135-583-30) 30 tablet2023-05-09NoNoCurrent