FDA.reportPublic FDA data

Glyburide

Product NDC
68788-4073
11-digit product format
687884073
Labeler code
68788
Product ID
68788-4073_bc8df889-25e0-49a0-bbec-a3dfae8bbb8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA074388
Marketing category
ANDA
Marketing start
2026-01-27
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
68788-4073-1Glyburide100 in 1 BOTTLETABLET1001
68788-4073-3Glyburide30 in 1 BOTTLETABLET301
68788-4073-6Glyburide60 in 1 BOTTLETABLET601
68788-4073-9Glyburide90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4073-1EA - Each68788-4073b2fb7f67-8c98-4829-b46c-139804a77a8f12026-03-17
68788-4073-3EA - Each68788-4073810d8b22-94e6-44a8-b5d1-2d20cd2b97dd12026-03-17
68788-4073-6EA - Each68788-40734dee7563-76fc-494b-9094-677c119d609d12026-03-17
68788-4073-9EA - Each68788-4073991f3eff-baa1-4169-9c0f-ff8e8ab883e412026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310537glyBURIDE 5 MG Oral TabletPSNbc8df889-25e0-49a0-bbec-a3dfae8bbb8a1
310537glyburide 5 MG Oral TabletSCDbc8df889-25e0-49a0-bbec-a3dfae8bbb8a1
310537glibenclamide 5 MG Oral TabletSYbc8df889-25e0-49a0-bbec-a3dfae8bbb8a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-4073-168788407301100 TABLET in 1 BOTTLE (68788-4073-1) 100 tablet2026-01-27NoNoHistorical
68788-4073-36878840730330 TABLET in 1 BOTTLE (68788-4073-3) 30 tablet2026-01-27NoNoHistorical
68788-4073-66878840730660 TABLET in 1 BOTTLE (68788-4073-6) 60 tablet2026-01-27NoNoHistorical
68788-4073-96878840730990 TABLET in 1 BOTTLE (68788-4073-9) 90 tablet2026-01-27NoNoHistorical