GLYBURIDE

Product NDC
51655-659
11-digit product format
516550659
Labeler code
51655
Product ID
51655-659_4b8239f0-5467-fb1e-e063-6294a90a7679
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLYBURIDE
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA090937
Marketing category
ANDA
Marketing start
2021-03-23
Substance
GLYBURIDE
Active strength
2.5 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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-659-522026-01-29C16284748780-149896155-afd6-586f-e063-e6dba90add90Glyburide Tablets, USP 1.25, 2.5, and 5 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-659-52GLYBURIDE30 in 1 BOTTLE, PLASTICTABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-659GLYBURIDE TABLET [NORTHWIND PHARMACEUTICALS]1Current NDC, 1 package rows20230321_db47a517-f8bb-136f-e053-2a95a90ad8c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310534glyBURIDE 2.5 MG Oral TabletPSNdb47a517-f8bb-136f-e053-2a95a90ad8c55
310534glyburide 2.5 MG Oral TabletSCDdb47a517-f8bb-136f-e053-2a95a90ad8c55
310534glibenclamide 2.5 MG Oral TabletSYdb47a517-f8bb-136f-e053-2a95a90ad8c55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-659-525165506595230 TABLET in 1 BOTTLE, PLASTIC (51655-659-52) 30 tablet2021-03-23NoNoCurrent