FDA.reportPublic FDA data

GLYBURIDE

Product NDC
71335-0150
11-digit product format
713350150
Labeler code
71335
Product ID
71335-0150_5e1bb26d-3543-48d5-9a08-c07f5dd5a688
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLYBURIDE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090937
Marketing category
ANDA
Marketing start
2010-10-05
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
71335-0150-1GLYBURIDE30 in 1 BOTTLETABLET30103
71335-0150-2GLYBURIDE120 in 1 BOTTLETABLET120103
71335-0150-3GLYBURIDE100 in 1 BOTTLETABLET100103
71335-0150-4GLYBURIDE60 in 1 BOTTLETABLET60103
71335-0150-5GLYBURIDE90 in 1 BOTTLETABLET90103
71335-0150-6GLYBURIDE180 in 1 BOTTLETABLET180103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0150-1EA - Each71335-015050c516dd-2561-4ffb-8c23-d48a3a1bc9ef12018-03-08
71335-0150-2EA - Each71335-015005ff37d5-b87d-4ddc-a2e6-fc7ee4f39a3b12018-03-08
71335-0150-3EA - Each71335-015079492804-1a05-4ab2-b9c9-aa6a7b01d88412018-03-08
71335-0150-4EA - Each71335-0150c4014803-05aa-4894-bb05-a8337a7bf94412018-03-08
71335-0150-5EA - Each71335-0150390e4e67-2659-4041-97d5-e99ef23d772512018-03-08
71335-0150-6EA - Each71335-01503514ca31-24cf-406c-9c6a-7473db75163612018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0150GLYBURIDE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 6 package rows20250221_05341afe-5b7a-462a-a196-689cb09f83fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310537glyBURIDE 5 MG Oral TabletPSN05341afe-5b7a-462a-a196-689cb09f83fc103
310537glyburide 5 MG Oral TabletSCD05341afe-5b7a-462a-a196-689cb09f83fc103
310537glibenclamide 5 MG Oral TabletSY05341afe-5b7a-462a-a196-689cb09f83fc103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0150-17133501500130 TABLET in 1 BOTTLE (71335-0150-1) 30 tablet2018-09-040000-00-00NoNoCurrent
71335-0150-271335015002120 TABLET in 1 BOTTLE (71335-0150-2) 120 tablet2025-01-280000-00-00NoNoCurrent
71335-0150-371335015003100 TABLET in 1 BOTTLE (71335-0150-3) 100 tablet2025-01-280000-00-00NoNoCurrent
71335-0150-47133501500460 TABLET in 1 BOTTLE (71335-0150-4) 60 tablet2018-07-230000-00-00NoNoCurrent
71335-0150-57133501500590 TABLET in 1 BOTTLE (71335-0150-5) 90 tablet2018-05-230000-00-00NoNoCurrent
71335-0150-671335015006180 TABLET in 1 BOTTLE (71335-0150-6) 180 tablet2021-02-120000-00-00NoNoCurrent