FDA.reportPublic FDA data

GLYBURIDE

Product NDC
51655-492
11-digit product format
516550492
Labeler code
51655
Product ID
51655-492_4a29bf9d-a9a0-408a-e063-6394a90af1ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLYBURIDE
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA090937
Marketing category
ANDA
Marketing start
2021-01-07
Substance
GLYBURIDE
Active strength
5 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GLYBURIDE
Listing expiration
2027-12-31

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
51655-492-25GLYBURIDE60 in 1 BOTTLE, PLASTICTABLET604
51655-492-26GLYBURIDE90 in 1 BOTTLE, PLASTICTABLET904
51655-492-52GLYBURIDE30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-492GLYBURIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 3 package rows20240127_d9cb9251-7b31-72a0-e053-2a95a90a4315.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310537glyBURIDE 5 MG Oral TabletPSNd9cb9251-7b31-72a0-e053-2a95a90a43154
310537glyburide 5 MG Oral TabletSCDd9cb9251-7b31-72a0-e053-2a95a90a43154
310537glibenclamide 5 MG Oral TabletSYd9cb9251-7b31-72a0-e053-2a95a90a43154

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-492-255165504922560 TABLET in 1 BOTTLE, PLASTIC (51655-492-25) 60 tablet2022-02-09NoNoHistorical
51655-492-265165504922690 TABLET in 1 BOTTLE, PLASTIC (51655-492-26) 90 tablet2023-11-16NoNoHistorical
51655-492-525165504925230 TABLET in 1 BOTTLE, PLASTIC (51655-492-52) 30 tablet2021-01-07NoNoHistorical