FDA.reportPublic FDA data

Glyburide

Product NDC
50090-6196
11-digit product format
500906196
Labeler code
50090
Product ID
50090-6196_f05d8f95-7681-41dd-91aa-d859ee049970
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203379
Marketing category
ANDA
Marketing start
2021-10-05
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
50090-6196-0Glyburide30 in 1 BOTTLETABLET304
50090-6196-1Glyburide100 in 1 BOTTLETABLET1004
50090-6196-2Glyburide60 in 1 BOTTLETABLET604
50090-6196-8Glyburide200 in 1 BOTTLETABLET2004
50090-6196-9Glyburide90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6196-0EA - Each50090-6196f620d333-3967-4518-b194-53083e64a48312022-12-07
50090-6196-1EA - Each50090-6196ef2472da-ffa3-493f-a5d8-c4e349d8099812022-12-07
50090-6196-2EA - Each50090-6196ed5d26bc-339d-4b6b-8574-332c93be203f12022-12-07
50090-6196-8EA - Each50090-6196a7cd83dd-1d39-4120-bab3-337eff8e3a7112022-12-07
50090-6196-9EA - Each50090-6196ae799820-79de-47d1-b4f8-1db3d7d4b97d12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6196GLYBURIDE TABLET [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 5 package rows20240103_d090f978-b1a5-4db7-951d-3f32dd06966c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310537glyBURIDE 5 MG Oral TabletPSNd090f978-b1a5-4db7-951d-3f32dd06966c4
310537glyburide 5 MG Oral TabletSCDd090f978-b1a5-4db7-951d-3f32dd06966c4
310537glibenclamide 5 MG Oral TabletSYd090f978-b1a5-4db7-951d-3f32dd06966c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6196-05009061960030 TABLET in 1 BOTTLE (50090-6196-0) 30 tablet2022-10-310000-00-00NoNoCurrent
50090-6196-150090619601100 TABLET in 1 BOTTLE (50090-6196-1) 100 tablet2022-11-040000-00-00NoNoCurrent
50090-6196-25009061960260 TABLET in 1 BOTTLE (50090-6196-2) 60 tablet2022-10-310000-00-00NoNoCurrent
50090-6196-850090619608200 TABLET in 1 BOTTLE (50090-6196-8) 200 tablet2022-11-040000-00-00NoNoCurrent
50090-6196-95009061960990 TABLET in 1 BOTTLE (50090-6196-9) 90 tablet2022-11-040000-00-00NoNoCurrent